7-10 November
Swan and Dolphin Resort
Orlando, Florida, USA
Table of Contents
Affiliate/Chapter Council Activities..................27
Annual Meeting Tracks...................................5-6
Career Solutions Onsite..................................26
COP Night Activities......................................26
CPIP
TM
Workshops..........................................22
Delegate Registration Form............................31
Education Schedule..........................................4
Education Sessions..................................... 7-22
Exhibit Information.........................................28
Event Highlights......................................... 27-28
General Information........................................29
Guest/Networking Registration Form..............32
Hotel Reservation Form..................................30
Keynote Speakers............................................3
Membership Benefits.......................................2
Networking Events.........................................26
Poster Presentations......................................25
Sponsors.......................................................33
Training.....................................................23-24
Young Professionals Activities.........................27
22
www.ISPE.org/2010AnnualMeeting
Discovering What’s Next:
Reality, Retooling, Growth
How will we know “what’s next” in our industry? How do
we prepare for it? Themed Discovering What’s Next:
Reality, Retooling, Growth, this year’s ISPE 2010 Annual
Meeting will help answer those critical questions and help
prepare each of us for what is to come.
2010 Annual Meeting features dozens of education
sessions, keynote addresses, poster presentations,
networking opportunities - plus special “to be announced”
hot topic sessions - and other “can’t miss” events taking
place 7-10 November in Orlando, Florida, USA.
It’s Easy to Register
Education Delegates
Review this brochure or visit www.ISPE.org/2010
AnnualMeeting to select the sessions you would like
to attend. Then register by either completing the Delegate,
Hotel, and Guest and Networking Events Registration Forms
at the back of this brochure and returning them to ISPE with
payment or register online.
Exhibiting Companies
Register to exhibit at www.ISPE.org/2010Annual
Meeting/Exhibits. Exhibiting companies will receive
confirmation packets by email that will include badge, floor
plan, and hotel registration forms.
Attendees of Annual Meeting will hear directly from
regulators and industry leaders, and get critical first-hand
understanding and important information you need to
face the future successfully. You’ll be able to network with
industry representatives from across the globe. Young
professionals and those new to the industry will have
dedicated events to speed your learning curve. In short, no
matter where you are in your career or what role you play in
the industry, you cannot afford to miss this event.
Membership Has Its Benefits
ISPE continues to reach out to cultivate new relationships
with a variety of industry sectors, while maintaining a level
of quality our Members expect. We trust that you will be
professionally enriched and that your business will grow as
a result of being a part of 2010 Annual Meeting.
Community
Registration details and up-to-date information are available
online at www.ISPE.org/2010AnnualMeeting.
We hope to see you in Orlando!
Sincerely,
Alan Mac Neice
Chair, ISPE International Board of Directors, 2009-2010
Knowledge
• Read Pharmaceutical Engineering, our exclusive
Members-only magazine
• Brush up on important industry topics with Knowledge
Briefs that are free to Members
•Get it done anytime with 24/7 access to our globally
renowned industry information located in the
Members-only section of www.ISPE.org
•Meet like-minded professionals through an Affiliate or
Chapter in your area
• Share ideas and find solutions to real world problems
through our Communities of Practice
• Build a network upon which you can rely for business
contacts, job leads, and friendly advice
Profession
• Demonstrate your competence with CPIPTM certification
• Become part of changing the industry by creating
a Guidance Document or getting involved in critical
initiatives such as PQLI®
• Help others grow professionally by being a Mentor
• Access resources to help you advance — even while the
industry changes around you — through ISPE’s Career
Solutions Center
ISPE...Your Society of Choice!
Keynote
Keynote Speakers
Speakers
2010
Experience the Business Behind the Magic.
Bruce G. Gellin, MD, MPH
Deputy Assistant Secretary for Health
Director, National Vaccine Program Office
Office of Public Health and Science
Office of the Assistant Secretary for Health
U.S. Department of Health and Human Services
As Deputy Assistant Secretary for Health and Director of
the National Vaccine Program Office (NVPO), Dr. Bruce
Gellin is one of our Nation’s top experts on vaccines and
infectious diseases. NVPO was created by Congress to
provide leadership and coordination among Federal agencies
and other immunization stakeholders, including states and
municipalities, health care providers, and private-sector
entities such as vaccine manufacturers.
Don’t let a down economy be a time for caution. This is a
chance to outpace your competition. In “Leading through
Turbulent Times,” explore the proven best practices that
underlie the Disney approach to sustaining excellence
during turbulent times. We will provide you with creative
strategies to weather the economic climate and effectively
meet the challenges of today’s business environment. These
strategies can easily be adapted to any organization or
industry to help retain customers, engage employees, and
position your organization for future ongoing success.
More to Come!
Visit www.ISPE.org/2010AnnualMeeting for
additional keynote presenters to be announced.
2010 Facility of the Year
Awards
The Overall Winner of the 2010 Facility of the Year Awards
program will be announced at the Keynote Session
– don’t miss this exciting announcement! The Overall
Winner will be selected from this year’s six Category
Winners as determined by an independent panel of
global representatives from the pharmaceutical design,
construction, and manufacturing sectors. This year’s
Category Winners include:
•
•
•
•
•
Biogen Idec
Genentech
MannKind Corporation (2 categories)
Pfizer Biotechnology Ireland
Pfizer Ireland Pharmaceuticals
www.ISPE.org/2010AnnualMeeting
3
SUNDAY, 7 NOVEMBER
TUESDAY, 9 NOVEMBER
WEDNESDAY, 10 NOVEMBER
13.00-17.00
08.15-11.30
08.15-12.15
101 - Global Trends in R&D Facilities:
Laboratories of the Future
302 - Designing a cGMP Facility in China
102 - Hygienic Systems
303 - Managing Cleaning Validation
and Assessments
103 - Sustainable Facilities: Sharing Lessons
Learned and Best Practices
105 - Construction Quality, Integrated C&Q and
ASTM E2500: Keys to Time to Market
106 - The Future of Nanotechnology in the
Pharmaceutical Industry
108 - The Science of Project Management (PM):
Defining Consistent Terminology Workshop
08.30-12.00
E01 - Keynote Session
13.30-14.30
CPIP
13.30-17.00
201 - HVAC cGMP Trends
TM
Introduction Workshop
202 - Sterile Manufacturing Facilities Update
203 - Managing Commissioning
204 - Regulatory Town Hall Forum
205 - Water for Injection (WFI)
206 - Commissioning and Qualification (C&Q)
Risk-Based Approach Forum: Process and Practices
208 - The Science of Project Management (PM):
Project Controls Systems
700 - Investigational Products: A Magical Journey to
Explore Reality, Retooling and Growth
15.00-16.00
44
CPIP How-to Workshop
www.ISPE.org/2010AnnualMeeting
501 - Offshoring Chemical and Pharma R&D
Towards Asia
502 - Calibration Management: A Risk-Based
Approach
CANCELLED
504 - Dosage Form Manufacturing: New Process
Technology
304 - Facility of the Year Awards Winner
Presentations
104 - Operational Excellence
MONDAY, 8 NOVEMBER
301 - GAMP® Outsourcing
305 - PQLI®: Pharma Quality Systems
505 - Clinical Manufacturing Implementation of
ASTM E 2500-07
306 - Pharmaceuticals in the Environment
506 - GAMP® Good Practice Guides
308 - Real Time Project: Build a Lab (highly
interactive, two-part session; please register
for both 308 and 408)
507 - Sustainable Design of Critical Utilities
508 - The Science of Project Management:
Construction Partnering
700 - Industrial Products: A Magical Journey to
Explore Reality, Retooling and Growth (Cont.)
700 - Industrial Products: A Magical Journey to
Explore Reality, Retooling and Growth (Cont.)
08.30-09.30
CPIP Introduction Workshop
10.30-11.30
CPIP How-to Workshop
14.00-15.00
CPIP How-to Workshop
TRAINING
14.15-17.15
401 - Working Effectively with the Emerging Markets
TUESDAY, 9 NOVEMBER
402 - Disposable Technologies Role in the Evolving
Biotech Marketplace
08.00-17.00
403 - Advanced Aseptic Processing Utilizing RABS
and Isolators
T07- Basic Principles of Computerized Systems
Compliance
08.30-17.00
T17- Cleaning Validation Principles
404 - Facility of the Year Awards Winner
Presentations
405 - PQLI®: Product Design, Development, and
Realization
406 - Advanced Process Monitoring and Control
407 - Biotech: Capacity, Single-Use, Gaskets
408 - Real Time Project: Build a Lab (highly
interactive, two-part session; please register for
both 308 and 408)
700 - Industrial Products: A Magical Journey to
Explore Reality, Retooling and Growth (Cont.)
09.00-10.00
CPIP How-to Workshop
WEDNESDAY, 10 NOVEMBER
08.00-15.30
T07- Basic Principles of Computerized Systems
Compliance
08.30-17.00
T17- Cleaning Validation Principles
Call For Hot Topics
Do you have a hot topic for a session at Annual Meeting?
The deadline for proposals is 30 June. Download the form
at www.ISPE.org/CallForProposals. Watch for
announcements about these late-breaking sessions.
Track Descriptions
Facilities and Equipment
501 - O
ffshoring of Chemical and Pharmaceutical R&D
towards Asia: Status Quo, Insights, Risks,
and Opportunities
101 - Global Trends in R&D Facilities: Laboratories
of the Future
Retooling for Operational Excellence
102 - H ygienic Systems: Biopharmaceutical
Process Equipment
103 - Sustainable Facilities: Sharing Lessons Learned and Best
Practices - Featuring Pfizer Biotechnology Ireland, Voted
2010 Facility of the Year Award Winner for Sustainability
201 - HVAC cGMP Trends and Developments in Bio/
Pharmaceutical and Medical Device Facilities
202 - Sterile Manufacturing Facilities Update
104 - A
Long Term Platform for Operational Excellence
303 - M
anaging Cleaning Validation and Assessments Sans
Paper - A Case Study C A N C E L L E D
Young Professionals
Young Professionals are an invaluable part of this growing
industry. The following sessions are seen as being applicable
across the industry and contain information that can be
beneficial to individuals at any stage in their career, but are
of particular benefit to professionals who are new to the
industry.
106 - T he Future of Nanotechnology in the Pharmaceutical Industry
304 - F acility of the Year Awards Winner Presentations
304/404 - Facility
of the Year Awards Winner Presentations
401 - Working Effectively with the Emerging Markets of China
and India
308/408 - T
he Science of Project Management (PM): Real
Time Project: Build a Lab (highly interactive, twopart session; please register for both 308 and 408)
404 - F acility of the Year Awards Winner Presentations
406 - A
dvanced Process Monitoring and Control in
Continuous Processing
Information Systems
205 - Water for Injection (WFI): A Changing Paradigm of
Production Methods
504 - Dosage Form Manufacturing: New Process Technology
302 - Designing a cGMP Facility in China for the
Global Market
Successful Delivery
303 - Managing Cleaning Validation and Assessments Sans
Paper - A Case Study
105 - C
onstruction Quality, Integrated C&Q and ASTM E2500:
Keys to Time to Market
506 - GAMP® Good Practice Guides: Updates You Can Use
304 - F acility of the Year Awards Winner Presentations
402 - D
isposable Technologies Role in the Evolving
Biotech Marketplace
403 - Advanced Aseptic Processing Utilizing RABS
and Isolators
404 - F acility of the Year Awards Winner Presentations
407 - Biotech Hot Topics: Capacity, Single-Use, and Gaskets
502 - Calibration Management: A Risk-Based Approach
505 - Clinical Manufacturing Implementation of
ASTM E 2500-07
507 - Sustainable Design of Critical Utilities: Innovative
Processes and Applications
Outsourcing
101 - Global Trends in R&D Facilities: Laboratories
of the Future
301 - GAMP® Outsourcing
302 - D
esigning a cGMP Facility in China for the Global Market
401 - Working Effectively with the Emerging Markets
of China and India
301 - GAMP® Outsourcing
502 - C
alibration Management: A Risk-Based Approach
203 - M
anaging Commissioning: The Evolving Role
of Your Contractor
Hot Topics
505 - Clinical Manufacturing Implementation of
ASTM E 2500-07
106 - T
he Future of Nanotechnology in the
Pharmaceutical Industry
507 - Sustainable
Design of Critical Utilities: Innovative
Processes and Applications
204 - Regulatory Town Hall Forum
Regulatory
205 - Water for Injection (WFI): A Changing Paradigm
of Production Methods
204 - Regulatory Town Hall Forum
302 - Designing a cGMP Facility in China for the
Global Market
206 - C
ommissioning and Qualification (C&Q) Risk-Based
Approach Forum: Process and Practices
401 - Working Effectively with the Emerging Markets of
China and India
305 - P
QLI® – Implementing ICH Q10: Moving a Pharma
Quality Systems Program Forward
407 - Biotech Hot Topics: Capacity, Single-Use, and Gaskets
306 - P
harmaceuticals in the Environment:
A Regulatory Perspective
501 - Offshoring of Chemical and Pharmaceutical R&D
towards Asia: Status Quo, Insights, Risks,
and Opportunities
405 - P
QLI® – Implementing ICH: Product Design,
Development and Realization, a Science- and
Risk-Based Approach to Implementation
www.ISPE.org/2010AnnualMeeting
5
Sustainability
Investigational Products
101 - Global Trends in R&D Facilities: Laboratories of
the Future
700 - Investigational Products – A Magical Journey to
Explore Reality, Retooling and Growth
103 - Sustainable Facilities: Sharing Lessons Learned
and Best Practices - Featuring Pfizer Biotechnology
Ireland, Voted 2010 Facility of the Year Award Winner
for Sustainability
507 - Sustainable Design of Critical Utilities: Innovative
Processes and Applications
Project Management
105 - C
onstruction Quality, Integrated C&Q and ASTM
E2500: Keys to Time to Market
203 - Managing Commissioning: The Evolving Role
of Your Contractor
Project Management Best Practices Series:
The Final Frontier. These are the voyages of the
Project Management Community of Practice.
Its continuing mission: To explore strange
new ideas... To seek out new methods, and
new practices... To Boldly Go Where No One
Project Has Gone Before! The Science of Project
Management series (108, 208, 308/408, 508)
will explore several topics over four distinct and
interrelated sessions.
108 - T
he Science of Project Management (PM): Defining
Consistent Terminology Workshop
208 - The Science of Project Management (PM): Project
Controls Systems & Implementation (PCSI) – An
Integrated Approach
308/408 - Real Time Project: Build a Lab (highly
interactive, two-part session; please register
for both 308 and 408)
508 - The Science of Project Management:
Construction Partnering
6
www.ISPE.org/2010AnnualMeeting
Days and Times for Special
Events
The full 2010 Annual Meeting schedule will be online at www.
ISPE.org/2010AnnualMeeting.
ISPE Community of Practice
(COP) Guide for Session
Descriptions
•A
ctive Pharmaceutical Ingredients (API)
• Biotechnology (Biotech)
•C
ommissioning and Qualification (C&Q)
• Containment
• Critical Utilities (CU)
• Disposables
•E
ngineering Standards Benchmarking (ESB)
•G
AMP®
•G
ood Control Laboratory Practices (GCLP)
•H
eating, Ventilation, and Air Conditioning (HVAC)
• Investigational Products (IP)
• Operations Management (OM)
• Oral Solid Dosage (OSD)
• Packaging
• Process Analytical Technology (PAT)
•P
rocess/Product Development (PPD)
• Project Management (PM)
•S
terile Products Processing (SPP)
• Sustainable Facilities (SF)
Preview. Post. Participate.
Stay connected during the 2010 ISPE Annual Meeting by
regularly visiting the ISPE Blog at ISPE.org/blog, our
Twitter page at twitter.com/ISPEorg, or our Facebook
page at facebook.com/ISPEorg.
Education
101 - Global Trends in R&D Facilities:
Laboratories of the Future
7 November 13.00-17.00
ISPE CEUs: 0.35
There is a global paradigm shift in the relocation of
Research and Development (R&D) facilities to China and
India from Europe and the US. What are the impacts to
R&D facilities of these shifts? What will these facilities look
like and how are they being designed differently? What
are the trends in sustainable laboratory design, green
chemistry, Labs21 in facility design? How are facilities
being redesigned to increase and support discovery?
The speakers in this session will represent owner R&D
engineering leaders from the US, Australia and China.
Leader
• Terry Jacobs, AIA, Principal, Jacobs/Wyper Architects,
LLP, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
•Discuss shifts in research and design facilities on a
global basis
• Understand the latest facility design trends in the
R&D environment
• Construct a global view of R&D from a facility perspective
• List trends in sustainable design for R&D
Who Should Attend
Principals and project managers from the design and the
owner community
ISPE Communities of Practice (COPs)
ESB, GCLP, HVAC, PM, and SF
Speakers to Date
• Norman Goldschmidt, Principal, VP Engineering, Genesis
Engineers Inc., USA
102 - Hygienic Systems: Biopharmaceutical
Process Equipment
Sponsored by the ISPE Commissioning and Qualification
Community of Practice
7 November 13.00-17.00
ISPE CEUs: 0.35
The goal of this session is to introduce the processes
and documentation used to comply with the ASME
BioProcessing Equipment (BPE) 2009 Standard. Attendees
will participate in the lifecycle activities involved in design,
specification, fabrication, and verification of hygienic piping
and bioprocess systems. The following activities will be
addressed:
• End-user requirements for a piping system (HP water or
process/product)
• Piping specification
• Purchase tubing/fittings from vendor
• Receipt inspection of materials
• Material test reports for all incoming materials
• Isometric drawing
• Welding (demonstration planned)
• Assemble document package, organize, review, and audit
• Acceptance by owner
Leader
•D
aniel Franklin, Regional Manager, Compliance Services,
IPS, USA
Sessions
• Understand the purpose of documents used in
fabrication of hygienic systems and how to use, review
and audit those documents
• Apply learning of hygienic systems fabrication and
certification requirements in hands-on workshop exercises
Who Should Attend
Process engineers, project engineers, verification resources
(C&Q), quality unit representatives, manufacturers/suppliers
of hygienic piping and components, hygienic process
system vendors, document control resources
ISPE Communities of Practice (COPs)
Biotech, C&Q, CU, and PM
Speakers to Date
• David Kwilosz, Associate Consultant Engineer, Eli Lilly and
Company, USA
• J ay Ankers, Director-Process Mechanical, LifeTek Solutions, USA
• Ryan Michalak, PE, Senior Process Engineer, Eli Lilly and
Company, USA
103 - Sustainable Facilities: Sharing Lessons
Learned and Best Practices - Featuring Pfizer
Biotechnology Ireland, Voted 2010 Facility of the
Year Award Winner for Sustainability
At the conclusion of this session, participants will be able to:
Sponsored by the ISPE Sustainable Facilities Community of
Practice
7 November 13.00-17.00
ISPE CEUs: 0.35
•U
nderstand the rationale for requirements definition,
relative to hygienic piping systems and process equipment
• Identify documentation requirements for purchase of
hygienic instrumentation and for welding of hygienic piping
and process systems as defined in the ASME BPE2009 Standard
• Understand lifecycle processes for design, specification,
fabrication, verification, and acceptance of hygienic piping
and equipment used for process and critical utilities
This session will focus on case studies and lessons learned
from the biopharm and other industries, including:
• Pfizer Biotechnology Ireland built its Monoclonal
Antibodies (MAbs) Small-scale Facility on a 29-acre site in
County Cork, Ireland, under the direction of a small team.
The facility was built using industry best practices for
sustainability and Pfizer’s green building guidelines.
• Food and Beverage industry lessons learned: Learn what
How You Will Benefit
www.ISPE.org/2010AnnualMeeting
7
methods the leaders in consumer and food products
industries are utilizing for conservation, cost containment,
and even brand recognition.
• US EPA’s Energy Star Challenge for Industry and
Pharmaceutical Focus
• ISO 14001: Environmental Management Systems Successes
Leader
•P
aul Malinowski, PE, PMP, Director, Project Management/
Corporate Engineering, Becton Dickinson and Co., USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Better understand the environmental sustainability
elements employed on Pfizer’s unique project
• Apply creative sustainable ideas from projects outside the
Pharma industry
• Understand the EPA’s new Energy Star Challenge program
• Understand what ISO 14001 is and how your company
can benefit from it
Who Should Attend
Architects, engineers, engineering managers/directors,
sustainability officers, facility engineers/managers,
energy, environmental, and project managers, and
maintenance professionals
ISPE Communities of Practice (COPs)
Biotech, CU, HVAC, OM, PM, and SF
Speakers to Date
• Bob Clark, PE, LEED AP, Senior Process Engineer, Burns
& McDonnell, USA
• Delores Guintu, EHS Consultant, Environmental and
Occupational Risk Management (EORM), USA
• J ames McGlade, Project Manager, O’Brien & Gere, USA
8
www.ISPE.org/2010AnnualMeeting
104 - A Long Term Platform for Operational
Excellence
7 November 13.00-17.00
ISPE CEUs: 0.35
This session will focus on operational excellence (OPEX)
recognizing that achievement of manufacturing excellence
is a long term effort that, to be successful, requires the
integration of multiple disciplines. Success is recognizing
manufacturing as a human activity based on technology
and science. Nothing happens without the long term efforts
of people and organizations. A series of core concepts
dominates the improvement efforts:
• Quality by design/science based approach
• Optimized Supply network
• Organizational alignment
• Lean/Six sigma
• Automation of processes
This cross-functional effort integrates several disciplines,
from process optimization to automation, engineering,
maintenance and quality assurance (GMP). Adopting these
ideas individually is usually a major effort and challenge to
a manufacturer. Ideally OPEX is integrated into the design
of future facilities with early involvement in conceptual and
basic design in order to ensure that the OPEX principles are
integrated into the design.
Leader
•L
asse Mønsted, Partner Global Consulting,
NNE Pharmaplan, DENMARK
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand the integrated elements that contribute to
operational excellence
• Establish goals of business process mapping
Who Should Attend
Managers and all pharmaceutical, biotechnology, contract
and generic manufacturers
ISPE Communities of Practice (COPs)
API, Biotech, GAMP®, OM, PAT, and PPD
Speakers to Date
• Carsten Holm Pedersen, Senior Consultant, Automation &
IT Consulting, NNE Pharmaplan, DENMARK
• Dean Priebe, Senior Consultant, NNE Pharmaplan, USA
105 - Construction Quality, Integrated C&Q
and ASTM E2500: Keys to Time to Market
7 November 13.00-17.00
ISPE CEUs: 0.35
A good CQM (Construction Quality Management) program
and a clear C&Q/Verification strategy, established at the
preconstruction stage of the project, can help translate
good engineering design into field execution/construction,
and help alleviate many of the problems encountered at the
back end of a project. The seminar will discuss some of
the challenges that are encountered from a construction/
field execution perspective and presents risk management
techniques predominantly used in the petrochemical/oil/
gas industries and how they may help the pharmaceutical
industry. Additionally, the session will discuss the new ASTM
2500 guide and how it can be successfully implemented
on a project. The session will concentrate on actual
project case studies and practical experience covering
construction quality, commissioning/qualification and
verification using the ASTM model.
Leaders
• Jay Lad, MD, SPGL (formerly the business of Skanska
Pharmaceutical Group), UNITED KINGDOM
• Bruce Beck, Director, Eli Lilly & Co., USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand why a good CQM Program and a clear
verification strategy, established at the preconstruction
stage, is crucial to the success or failure of a capital project
• Develop and apply a CQM program
• Implement a verification strategy using the new ASTM
E2500 model
• Examine recent examples of pharmaceutical projects
applying risk based techniques and how they transitioned
from traditional approaches to leaner C&Q approaches
Who Should Attend
Those involved in or responsible for the specification, design,
and verification of pharmaceutical and biopharmaceutical
manufacturing systems and equipment: process, project and
plant engineering disciplines, manufacturing operations, QA/
validation, process development and technology transfer
personnel, project managers, construction managers,
commissioning and qualification specialists, engineers,
scientists.
ISPE Communities of Practice (COPs)
Biotech, C&Q, and PM
106 - The Future of Nanotechnology in the
Pharmaceutical Industry
7 November 13.00-17.00
ISPE CEUs: 0.35
Nanotechnology is a growing presence in several
market sectors. From 2007 to 2015, the market for
nanotechnology in manufacturing goods alone is forecast
to expand at a compound annual growth rate of 33% and
a major component of this growth is expected to be in
pharmaceuticals. This session will discuss nanotechnology
approaches developed for pharmaceutical applications
and technologies including: fullerenes (buckyballs) as drug
carriers, nanotubules for drug delivery, nanoparticles
(e.g., liposomes, dendrimers, micelles), nanospheres,
molecular nanotechnology, and the potential integration of
nanotechnology and drug-delivery platforms (i.e. MicroElectro-Mechanical Systems or MEMS). Understanding the
potential strengths and weaknesses of these approaches
along with the regulatory and compliance considerations is
essential to leveraging the full potential of these emerging
technology platforms.
Leaders
•B
ikash Chatterjee, President & CTO, Pharmatech
Associates Inc., USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand the technical, quality, and regulatory
considerations of nanotechnology
• Understand potential applications for nanotechnology
within the lifesciences arena
• Understand the limitations and hurdles to implementing
nanotechnology today
• Discuss challenges facing Pharma today in implementing
nanotechnology
Who Should Attend
Quality, R&D, product development, business development,
process development and regulatory professionals
108 - The Science of Project Management (PM):
Defining Consistent Terminology Workshop
Sponsored by the ISPE Project Management Community of
Practice
7 November 13.00-17.00
ISPE CEUs: 0.35
terms and terminology. Project managers, sponsors,
team members, and end-users all need to speak the same
language to make sure that we get the same outcome!
Come help define the terminology common to our projects,
and identify if these hold their definition at all project
phases. The PM Best Practice Guide will be the playbook for
future Project Managers, and your interest and involvement
in this workshop will be of great benefit to the effort, and
help you as a PM standardize your own project management
vocabulary!
Leader
• Patricia Melton PhD, MBA, Managing Director, MIME
Solutions Ltd., UNITED KINGDOM (Past-Chair PMCOP)
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Identify the areas where conflicting terminology and
misleading communication can most greatly impact the
outcome of a project
Who Should Attend
Project Managers of all types
ISPE Communities of Practice (COPs)
PM
Speakers to Date
• Keith Gibbs, Corporate Manager of Technical Services,
Commissioning and Qualification, Yonkers Industries, Inc.,
USA (Chair, PMCOP)
• Dave Koncak, Director of Engineering, Pfizer Inc., USA
(Co-Chair, PMCOP)
Project Management Best Practices: The Final Frontier.
When you get involved in projects, does it feel like everyone
around you is speaking Klingon? This kickoff session will use
a fast paced, audience interaction strategy to define PM
common language and discuss how often communication
can break down on a project as a result of confusion over
www.ISPE.org/2010AnnualMeeting
9
201 - HVAC cGMP Trends and Developments
in Bio/Pharmaceutical and Medical Device
Facilities
Sponsored by the ISPE HVAC Community of Practice
8 November 13.30-17.00
ISPE CEUs: 0.25
GMPs for pharma HVAC facilities vary across the global
market place. Good operational practices may be the
key to cGMP operations, but a poor facility design can
hamstring even the best operations. Two core HVAC focus
areas are regulation and cleanroom filter standards. This
session explores the latest developments in regulation and
standards with a special focus on misunderstood and often
overlooked issues. The comparison will focus on US FDA,
EMA, WHO, PIC/S, and TGA, among others.
Leader
• Norman Goldschmidt, Principal, VP Engineering, Genesis
Engineers Inc., USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
•D
iscuss recent changes in HVAC related regulations from
around the world
• Understand differences among global HVAC regulations
• Discuss the conflicts between cGMP and other regulations
• Analyze specific standards impacting cleanroom design,
such as changing filter standards, cleanroom testing, and
how they relate to product protection
ISPE Communities of Practice (COPs)
HVAC
202 - Sterile Manufacturing Facilities Update
Sponsored by the ISPE Sterile Products Processing
Community of Practice
8 November 13.30-17.00
ISPE CEUs: 0.25
One of the biggest challenges that the sterile manufacturing
industry faces is the interpretation, harmonization, and
qualification of cleanroom classifications. The session will
address this situation and share examples of how some
manufacturing companies have successfully complied with
the various requirements to get their facilities qualified
and some applied examples of Annex 1 compliance and
interpretation by end users.
Leader
• Bruce Davis, Principal Consultant, Global Consulting,
UNITED KINGDOM
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand different room classification ratings and how
they correlate across regulatory agencies
• Utilize a cross reference for cleanroom specifications to
comply with FDA and EMA requirements
• Apply actual case study examples to their situation
Who Should Attend
Sterile facility and manufacturing engineers, architects,
quality, designers, project managers, and anyone involved
with sterile manufacturing
ISPE Communities of Practice (COPs)
www.ISPE.org/2010AnnualMeeting
203 - Managing Commissioning: The Evolving
Role of Your Contractor
8 November 13.30-17.00
ISPE CEUs: 0.25
A majority of projects that don’t get completed on time
can cite a poorly managed commissioning effort since
commissioning typically doesn’t garner real attention
early enough. However, commissioning can be properly
purchased, managed and accurately scheduled. Some
common industry misconceptions include: commissioning
is purchased with plans and specification, commissioning
occurs at the end of the project, is the last task of a project
schedule, and commissioning and validation are two distinct
processes and cannot work together. There’s been a
tremendous increase in the number of projects that require
some level of commissioning. Major reasons include:
• Heightened focus on occupant/client satisfaction
• Smooth transition to the client takeover of the project
• ‘Speed to Market’ challenges
• Building systems/new technologies are far more complex
and interdependent
The session will address the basic steps to managing a
successful commissioning process.
Leader
• William Lefebvre, LifeScience Center of Excellence
Leader, Gilbane, USA
HVAC and SPP
How You Will Benefit
Speakers to Date
• Effectively purchase commissioning services
• Manage the commissioning process more effectively
• Understand how to connect the commissioning schedule
to the main project schedule
• Establish a common success criteria for projects
• Gordon Farquharson, Principal, Critical Systems Ltd.,
UNITED KINGDOM
• Patrick Poisson, VP Manufacturing, Fill/Finish, United
Therapeutics, USA
10
• Christoph Scheuerlein, Director GMP Compliance, Cilag
AG, SWITZERLAND
At the conclusion of this session, participants will be able to:
Who Should Attend
Facility directors and personnel, project managers,
maintenance and plant managers, and professionals
ISPE Communities of Practice (COPs)
API, Biotech, Containment, CU, HVAC, Packaging, PM, and SF
Speakers to Date
• John Whitfield, Field Operations Manager, Primary
Integration Solutions, USA
• Henry Ford, Program Manager, Primary Integration
Solutions, USA
•R
obert Chew, PE, President, Commissioning Agents, Inc., USA
204 - Regulatory Town Hall Forum
8 November 13.30-17.00
ISPE CEUs: 0.25
The Regulatory Forum will provide an opportunity to
hear from senior leaders of global regulatory agencies.
Each regulatory speaker will provide a brief update on
key developments with which their agency is currently
concerned. A major part of the session will be interactive
and participatory. Attendees will be encouraged to put their
questions to this distinguished panel either by voicing their
questions or by writing them on questions cards submitted
during the first part of the session. The regulatory agency
leaders from both review and inspectorate divisions will
participate.
Leaders
•D
r. Nirdosh Jagota, Senior Director Pharma Technical
Regulatory Genentech, USA
•G
ordon Muirhead, Vice President (Solid Orals),
GlaxoSmithKline, UNITED KINGDOM
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand global regulatory topics and perspectives
• Explain current regulatory initiatives
• A pply insights from industry questions and answers
with regulators
Who Should Attend
Manufacturing industry representatives and regulatory
professionals
ISPE Communities of Practice (COPs)
All
Speakers to Date
• Global regulators representing various regions
The results of industry surveys including an ISPE sponsored
survey on the topic will be presented.
Leader
• Andrew Collentro, Technical Director, Water Consulting
Specialists, Inc., USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Examine the impact of potential monograph changes for
WFI
• Evaluate differences between EP, USP, and other
global compendia
• Determine the viable technologies for WFI generation
• A ssess the risks associated with alternate WFI
generation methods
Who Should Attend
205 - Water for Injection (WFI): A Changing
Paradigm of Production Methods
Sponsored by the ISPE Critical Utilities Community of
Practice
8 November 13.30-17.00
ISPE CEUs: 0.25
The European Pharmacopeia Monograph for Water for
Injection (WFI) currently limits the method of manufacture to
distillation, while the United States Pharmacopeia (USP) was
recently modified to be non-specific on the requirement.
The European Directorate for the Quality of Medicines has
now solicited input from USP and parenteral manufacturers
regarding the expansion of generation methods to reverse
osmosis and possibly alternate technologies. This session
will examine the possibility of using non-distillation
technologies for the production of WFI currently employed
in the United States and generation methods for WFI quality
waters. Presentations will discuss successful operations
as well as the potential concerns and risks associated with
non-traditional generation methods.
Design, process, and utility/facility engineers/project managers
ISPE Communities of Practice (COPs)
C&Q, CU, PM, and SPP
206 - Commissioning and Qualification (C&Q)
Risk-Based Approach Forum: Process and
Practices
Sponsored by the ISPE Commissioning and Qualification
Community of Practice
8 November 13.30-17.00
ISPE CEUs: 0.25
Streamlined C&Q processes based on Risk and Science
approaches can improve compliance (consistent application
of a defined process focusing on product risk and quality),
reduce the capital project timelines (improve ROI), and
reduce lifecycle costs (through reduction of the number
of systems under GMP Change Control). Implementation
of these approaches tends to challenge current culture
and established practice. Users/Owners have made
www.ISPE.org/2010AnnualMeeting
11
varying levels of progress in the transition, but processes,
associated practice and metrics have not been fully
developed and owners/users cannot gauge alignment and
progress. In 2009 a user/owner task team was formed
to compare approaches, identify current practices and
benchmark progress against key principles. At ISPE Annual
Meeting 2009, a forum was held on findings to date and
attendees provided input. The session continues this work
with a task team presentation, new participant survey and
an opportunity for attendees to challenge the panel.
Leaders
•M
ark Rezac, Associate Engineering Director, Merck &
Company Inc., USA
• Steven Wisniewski, Senior Associate Director of
Compliance, IPS, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
•U
nderstand the challenges faced implementing riskbased C&Q approaches
• Examine ideas from other pharmaceutical operating
company professionals currently implementing riskbased methodologies
• Propose the best approach for your organization
Who Should Attend
Project Engineers, Project Managers, Commissioning and
Validation Professionals, Quality Professionals
ISPE Communities of Practice (COPs)
C&Q, CU, GAMP®, HVAC, and PM
Speakers to Date
• Nicholas Andreopoulos, Senior Manager, Pfizer, USA
• David Dolgin, Senior Quality Program Manager, Abbott
Labs, USA
• Rose Mary Dollard, Manager, Commissioning and
Qualification Services, Johnson & Johnson, USA
12
www.ISPE.org/2010AnnualMeeting
• Michelle Whipple, Associate Director, QA Validation,
Bristol-Myers Squibb, USA
208 - The Science of Project Management (PM):
Project Controls Systems & Implementation
(PCSI) – An Integrated Approach
Sponsored by the ISPE Project Management Community
of Practice
8 November 13.30-17.00
ISPE CEUs: 0.25
This session explores how Genentech outlined an
organization-wide integrated project controls system
supporting capital projects through the entire lifecycle.
Through the use of proven and supported off-the-shelf
software components knitted together by an overlying
architecture to insure reliability, an organization can
obtain ease of use and implementation with minimal
training. A common WBS structure designed to allow
data to cascade from the estimating platform to follow-on
scheduling, change control, cost forecasting and unified
portfolio reporting allows Project Managers, estimators,
schedulers, and cost engineers to work in their specialized
spheres yet produce consistent, actionable information
and share data with the entire organization. Contractual
tie-in allows contractor changes to be executed directly in
the change module. Built-in scalability allows all sizes of
projects and levels of detail to be accommodated based
on management discretion. A portfolio approach gives
a complete perspective with data mining capabilities to
provide specific contextualization when required. Agreed
reporting deliverables and a regular reporting cycle
provides all levels of management with clear and concise
data for decision-making. This integrated project controls
approach enhances the overall breadth and depth of
project execution and control.
Leader
• J ohn Honey, Associate Director, Facilities Engineering,
Genentech Inc., USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Identify the elements to consider in common reporting
platforms
• Analyze and organize the common reporting elements
pertinent to their organization
Who Should Attend
Project managers, estimators, schedulers, and cost engineers
ISPE Communities of Practice (COPs)
PM
301 - GAMP® Outsourcing
Sponsored by the ISPE GAMP® Community of Practice
9 November 08.15-11.30
ISPE CEUs: 0.23
This session will focus on the critical elements of outsourcing
where success depends on senior management support,
open communication, and your organization’s ability to
manage the service providers. Professionals in both
organizations require skills in negotiation, communication,
project management, the ability to define and understand
the terms and conditions of contracts and service level
agreements (SLAs), and the willingness to be flexible as
business needs change on either side of the partnership.
These issues become especially challenging when the work
is being done in different countries due to differences in
language, culture, and time zones. There are four basic
phases in an effective strategy: (1) Planning - developing
perspective as to the scope of outsourcing in its activities;
(2) Evaluation and selection - determining outsourcing
projects, and appropriate service providers; (3) Contract
definition - determining the legal, pricing and SLA terms; and
(4) Governance - managing the ongoing working relationships.
Leader
Leader
How You Will Benefit
How You Will Benefit
• Winnie Cappucci, PS Compliance IT Sys NA, Bayer
Healthcare, USA
At the conclusion of this session, participants will be able to:
• Understand the breadth of professional skills needed
among the professionals involved on both sides of the
outsourcing project
• Identify the four major phases of the outsourcing project
• Determine an outsourcing approach for your company
• J ames Dougherty, Senior Vice President, Biokinetics
Foster Wheeler, USA
At the conclusion of this session, participants will be able to:
• Outline some of the challenges with building and
manufacturing strategies for pharma companies
expanding into China
•U
nderstand regulatory challenges as they impact Chinese
manufacturing projects
• More effectively examine proposed projects involving
expansion into China in order to identify areas that may
represent challenges not faced in other countries
on content, while smart technology can take care of
implementing the business and compliance rules
Leader
• Nagesh Nama, President, Valimation Inc., USA
How You Will Benefit
Operations/manufacturing professionals, program and
project managers, senior stakeholders responsible for
international project execution, architects and engineers,
and regulatory and validation professionals
At the conclusion of this session, participants will be able to:
• Analyze how a paperless, automated system can manage
the entire cleaning validation lifecycle
• Discuss the value of a paperless system as it prioritizes
good practices and processes
• Examine how the new paperless platform can save cost
while increasing efficiencies
• Describe how this approach can facilitate collaboration
•Identify how to convert mounds of information collected
during validation efforts into knowledge
• Describe how to implement standards that are typically
buried in SOPs and policies
•T
homas Fuchs, Head Global QA/E-Compliance, Novartis
Pharma AG, SWITZERLAND
ISPE Communities of Practice (COPs)
Who Should Attend
302 - Designing a cGMP Facility in China for the
Global Market
303 - Managing Cleaning Validation and
Assessments Sans Paper - A Case Study
ISPE Communities of Practice (COPs)
Who Should Attend
Anyone whose position requires them to play a role in an
outsourcing project
ISPE Communities of Practice (COPs)
Biotech, C&Q, GAMP®, and GCLP
Speakers to Date
9 November 08.15-11.30
ISPE CEUs: 0.23
Successful execution of projects in China is extremely
complex. This session will explore the strategies and
challenges associated with building manufacturing
facilities in China to meet US FDA and EU EMA, as well as
Chinese SFDA standards. The session will also examine
the role of the Chinese government in these projects. Key
considerations are project execution, the development
of the project team, and integration of various resources
needed to support these project(s). This session will enable
participants to better understand issues and regulatory
challenges, and apply them to their operations.
Who Should Attend
PM
9 November 08.15-11.30
ISPE CEUs: 0.23
CANCELLED
This session demonstrates paperless cleaning validation
and assessments that leverage web 2.0 technologies. This
approach can increase efficiencies while saving dollars
for the FDA regulated industry. Attendees will witness this
paperless platform in action while the status quo is likely to
take the typewriter route. This web seminar will:
• Showcase a live demonstration
• Include web-based automated cleaning assessments,
automated generation of protocols, and online
protocol executions
• Demonstrate that all involved personnel can focus
Validation managers, IT directors and managers, quality
assurance managers, quality control managers, managers
of document management and control
C&Q and GAMP®
Speakers to Date
• Jim McElroy, Manager, Technical Process Leader Contract, Novartis, USA
304 - Facility of the Year Awards Winner
Presentations
9 November 08.15-11.30
ISPE CEUs: 0.23
This session will feature presentations by each of the
Category Winners from the 2010 Facility of the Year Awards
www.ISPE.org/2010AnnualMeeting
13
(FOYA) program. Delegates will have the opportunity to learn
about the latest, state-of-the-art developments being
implemented, learn more about the winning projects, and
see how excellence was delivered via innovative thinking.
Speakers will include representatives from the following
2010 Category Winning companies:
• Biogen Idec, winner of the Facility of the Year Award for
Operational Excellence
•Genentech, winner of the Facility of the Year Award for
Project Execution
• MannKind Corporation, winner of the Facility of the Year
Awards for Equipment Innovation and Process Innovation
• Pfizer Biotechnology Ireland, winner of the Facility of the
Year Award for Sustainability
•Pfizer Ireland Pharmaceuticals, winner of the Facility of the
Year Award for Facility Integration
Leader
• James McGlade, AIA, LEED AP, Project Manager,
O’Brien & Gere, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Explain innovative approaches to solving facilities
challenges and reducing costs
• Develop new philosophies to enable cutting-edge
approaches to complex projects
•Understand novel collaborative partnerships collaborating
not only on a projects
9 November 08.15-11.30
ISPE CEUs: 0.23
Invited regulatory and industry speakers from North
America and Europe will describe current implementation
of the principles of a Pharmaceutical Quality System
(PQS) as described in ICH Q10 in their respective region.
Regulators will be asked to comment if and how a modern
PQS encompassing good manufacturing practice, quality
assurance, quality control, and quality risk management
could assist in reducing risk from hot topic compliance
issues. PQLI® leaders will describe the PQS Program, and
describe how hot topics are being addressed. There will be
opportunities to question regulators and PQLI® Topic Leaders.
306 - Pharmaceuticals in the Environment: A
Regulatory Perspective
Sponsored by the ISPE Containment Community of Practice
9 November 08.15-11.30
ISPE CEUs: 0.23
Who Should Attend
Leader
• Joseph Famulare, Senior Director, External Influence &
Compliance, Genentech Inc., USA
How You Will Benefit
ISPE Communities of Practice (COPs)
ISPE Communities of Practice (COPs)
14 www.ISPE.org/2010AnnualMeeting
• Rob Hughes, Head PPQA, AstraZeneca, UNITED KINGDOM
At the conclusion of this session, participants will be able to:
•U
nderstand practical examples of implementation of a PQS
•U
nderstand if a modern PQS can assist with reducing
compliance risk
• Contribute to the latest thinking on implementation of a
PQS based on the principles as described in ICH Q10
Leader
Senior management from owner companies, project
managers, architects, engineers, members of construction
companies, and vendors
All
Speakers to Date
The US Environmental Protection Agency (EPA) is now
considering pharmaceuticals for potential regulation by
the Safe Drinking Water Act. This session will address the
implications of a recently published list of 104 chemicals
and 12 microbes being considered for regulation along with
several estrogens and the antibiotic Erythromycin which
are additionally on the agency’s Contaminant Candidate
List. For the first time, the list of potential contaminants
includes several widely used pharmaceuticals including
estrogens, pesticides, and two major perfluorinated
compounds. By 2013 the EPA will determine whether to
propose drinking water standards for at least five of them.
Some publically owned treatment works are evaluating the
impact of pharmaceuticals and commercial chemicals on
the operation of their facilities and may require enhanced
monitoring and discharge limits from users. Attend this
session to learn more about this potential regulation and its
impact on the pharmaceutical manufacturing industry.
Every engineer, manufacturing person and CMC professional
is impacted in implementation of a PQS. That is all of us! A
PQS impacts not only those involved in traditional compliance
and QA/QC activities but extends to all those involved in
manufacture, plant design, and regulatory submissions as
well as people developing products and processes.
Who Should Attend
14
305 - PQLI® – Implementing ICH Q10: Moving a
Pharma Quality Systems Program Forward
All
• G
eorge Petroka, Director, BioPharma/EHS Services, IES
Engineers, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand the proposed EPA Rulemaking on the
Regulating of Pharmaceuticals in the Nation’s Drinking
Water Supplies as well as the potential impact to their
facility and operations
• Discuss its potential impact on the pharmaceutical
manufacturing industry
• Utilize additional resources to learn more about
developing regulations
Who Should Attend
Facility and process engineers, formulators, environmental
and safety professionals, and QA/QC professionals
ISPE Communities of Practice (COPs)
Containment and SF
308 - The Science of Project Management (PM):
Real Time Project: Build a Lab
(Highly interactive, two-part session; please register
for both 308 and 408)
Sponsored by the ISPE Project Management Community
of Practice
9 November 08.15-11.30
ISPE CEUs: 0.23
Working with Leaders, participants will be tasked with
providing direction, oversight, and decisions to plan,
design, construct, and commission a laboratory facility.
This will be accomplished by utilizing electronic tags, and
the team will move forward using the majority decisions of
the audience. Three teams will be formed and will interact
with participants to make decisions as the project planning
moves forward:
• Owners Team: Sets the basic business plan, project
criteria, project delivery, and has decision power
• Design Team: Provides Architectural and Mechanical
Electrical Plumbing (MEP) design for the project
• Construction Team: Provides pre-construction and
construction activities.
Among the decisions that the audience might provide are:
• Various owners decisions include most critical project
success criteria, project delivery method, schedule, cost,
and commissioning options
• Various design decisions include adjacencies, lab,
support, and MEP configurations
• Various construction decisions might include schedule
critical path options, value engineering options,
constructability options, and subcontracting strategies
Leaders
•Keith Gibbs, Corporate Manager, C&Q, Yonkers Industries,
USA
• Gerard J. Guillorn, Vice President, Structure Tone Inc., USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
•A
ctively participate in the decision making process
associated with the planning, design, construction, and
commissioning of a laboratory facility
•Better manage capital projects to build a facility in real time
• Appraise how decisions are made by different units and in
some cases, overturned in capital project execution
Who Should Attend
Anyone involved in planning, design, construction, and
commissioning of capital projects, at any level, whether
with an owner organization, a consulting or design firm, or a
construction firm
ISPE Communities of Practice (COPs)
C&Q, GCLP, and PM
401 - Working Effectively with the Emerging
Markets of China and India
9 November 14.15-17.15
ISPE CEUs: 0.25
The pharmaceutical market landscape has been changing
rapidly over the last five years. China and India’s emergence
as major pharmaceutical markets, providing over 40% of
APIs in US pharmaceuticals, has complicated traditional
growth in the US market place. It is becoming inconceivable
that a growth strategy does not include these markets in
the drug development process. This session will discuss
the requirements to operate in these countries considering
the quality, technical, logistical, and cultural challenges
necessary to be successful. The discussion, based on
first-hand experience by the presenters, will distinguish
between the propaganda of the press and the state of these
marketplaces. The focus will include US and Chinese/Indian
driven initiatives, the differences in facility construction, and
process utility design. Understanding these differences is
essential to establishing an effective plan. Given the latest
regulatory actions in India and the potential impact of the
newly updated GMPs in China, understanding the true lay of
the land is essential to crafting an effective strategic and
tactical plan.
Leader
• Bikash Chatterjee, President & CTO, PharmaTech
Associates Inc., USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand the technical, quality, logistical capabilities
necessary to succeed in China and India
• Describe some of the regulatory challenges
• Outline how some of the cultural differences impact pharma
international collaborations
Who Should Attend
Directors, supply chain and quality professionals, technology
transfer, and scale-up professionals
www.ISPE.org/2010AnnualMeeting 15
Speakers to Date
•L
arry Kranking, President, Aveta Lifesciences USA, USA
• Ram Balani, CEO, FDASmart, Inc., USA
402 - Disposable Technologies Role in the
Evolving Biotech Marketplace
Sponsored by the ISPE Disposables and Biotech
Communities of Practice
9 November 14.15-17.15
ISPE CEUs: 0.25
Biotech is experiencing an increase in success rates and
increased yields. Increasing titers are reducing the volume
of bioreactor capacity. More antibodies with smaller market
penetration are lowering product mass requirements.
Collective implications suggest that decreased plant size
will create a need for more flexible facilities and disposable
technologies may have greater application for commercial
supply. However, there are a number of issues that need
to be resolved and this seminar will attempt to address the
following:
and barriers including compatibility issues,
• Hurdles
component interchangeability, supply chain risk,
ergonomics, integration with stainless, and assuring
integrity of disposable systems
in technologies for downstream processing
• Advances
and final filling
• Waste management
analysis tools to help determine where to
• Business
implement disposables throughout the product lifecycle
• Development of a combined roadmap for successful
implementation from phase one to commercial
manufacturing (BPSA, PDA, ISPE, and ASME)
Leader
• Miriam Monge, VP Marketing & Disposables
Implementation, Biopharm Services Ltd., FRANCE
16
www.ISPE.org/2010AnnualMeeting
How You Will Benefit
At the end of this session, participants will be able to:
• Understand the technical and financial tools available for
evaluation in the implementation of disposable technologies
• Apply risk management methodology for evaluating
disposable technologies
•Analyze disposable waste management alternatives
• Understand standards being developed by varying
industry associations
Who Should Attend
Professionals from engineering, process development,
manufacturing, validation, and procurement
ISPE Communities of Practice (COPs)
API, Biotech, Disposables, SPP, and SF
Speakers to Date
Leader
• J ack Lysfjord, Principal Consultant, Lysfjord Consulting
LLC, USA
How You Will Benefit
At the end of this session, participants will be able to:
• Explain updated technologies applicable to advanced
aseptic processing
• Understand what to do and what not to do from those who
have done it before
• Answer questions on advanced aseptic processing issues
Who Should Attend
Engineering professionals, operations, validation, regulatory
and project management personnel, and equipment
vendors involved in aseptic processing
ISPE Communities of Practice (COPs)
•W
ayne Flaherty, President, Compliance Concepts
International, Inc., USA
• Adam Goldstein, Senior Manager, Clinical Operations,
Genentech, USA
• Ernie Jenness, Senior Product Manager, Mobius Solutions,
Millipore Corporation, USA
•David Wolton, VP of Manufacturing, CMC Biologics A/S,
DENMARK
SPP
403 - Advanced Aseptic Processing Utilizing
RABS and Isolators
404 - Facility of the Year Awards Winner
Presentations
Sponsored by the ISPE Sterile Products Processing
Community of Practice
9 November 14.15-17.15
ISPE CEUs: 0.25
This session will discuss the hot topics of RABS and
Isolators for fill finish applications and is an appetizer
version of the June Barrier Isolator Technology Seminar
for state of the art technology updates and case studies.
Advanced Aseptic processing is the cGMP for today’s fill
finish applications.
Program Committee Members
• Charlotte Enghave Fruergaard, PhD, Senior Consultant,
NNE Pharmaplan, DENMARK
• Michael Porter, Director, Technical Operations, Merck &
Company Inc, USA
• Gordon Leichter, PhD, Sales Manager, Belimed, USA
9 November 14.15-17.15
ISPE CEUs: 0.25
See session 304 for details.
405 - PQLI® – Implementing ICH: Product
Design, Development and Realization,
a Science- and Risk-Based Approach to
Implementation
9 November 14.15-17.15
ISPE CEUs: 0.23
There is a need to provide a range of tools for developing
products and their manufacturing processes using the
enhanced, quality by design (QbD) approach described
in ICH guidelines, Q8 (R2), Q9 and Q10. Presentations in
this session will feature the ISPE Product Quality Lifecycle
Implementation® (PQLI®) approach to product design,
development, and realization in a science- and risk-based
fashion. An approach to needed guidance will be described,
a small molecule illustrated example will be provided, as
well as interactive discussion on the topics of (1) critical
quality attributes and critical process parameters, (2)
design space, and (3) control strategy. Active attendee
participation/discussion is encouraged in this session
and ideas generated may be included in the upcoming
development of ISPE guidance documents.
Leader
• Stephen Tyler, Director Strategic Quality & Tech Ops,
Abbott Laboratories, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand the PQLI® approach to implementation of ICH guidelines
• Contribute to an ongoing discussion to identify where
tools and processes are needed to help industry with
effective implementation
• Explain what is meant by critical quality attributes and
process parameters
• Discuss design space
• Examine control strategy
Who Should Attend
Any professional involved in product design, product
realization, process and engineering design scientists,
regulatory professionals, QA/QC/Compliance, validation,
technology transfer and manufacturing professionals;
anyone working with small or large molecules, and in a
small, medium, or large company, innovator, OTC or generic
and at any level
ISPE Communities of Practice (COPs)
API, OM, OSD, PAT, and PPD
Speakers to Date
• John V. Lepore, PhD, Senior Director, Commercialization,
Merck & Co. Inc., USA
•L
ine Lundsberg-Nielsen, PhD, Senior Consultant, NNE
Pharmaplan, UNITED KINGDOM
•R
oger Nosal, Executive Director, Pfizer Inc., USA
• Christopher Sinko, PhD, Vice President, Bristol-Myers
Squibb, USA
406 - Advanced Process Monitoring and Control
in Continuous Processing
Sponsored by the ISPE Active Pharmaceutical Ingredients
and Process Analytical Technology Communities of Practice
9 November 14.15-17.15
ISPE CEUs: 0.25
This session will focus on the use of Process Analytical
Technology (PAT) for advanced process control and
monitoring in continuous processing. It will include:
• Strategies for use of PAT in multivariate statistical
process control, feedback, and feed-forward control of
continuous processing
•C
ase studies displaying the benefits of continuous processing
• Use of PAT can increase process understanding, monitor
and control processes to ensure consistent, high quality
products
• PAT in continuous processing leads to higher process
capability and fewer process upsets
Leader
• Richard McCabe, Senior Manager GMS, Pfizer, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand the importance of PAT in continuous
processing and its use in developing process
understanding and a control strategy that includes
feedback and feed-forward control
• List disciplines considered and departments involved to
execute a successful continuous process
• Transfer case study information from laboratory to pilot
and manufacturing to the benefit of their own company
•Understand state-of-the-art technologies that support
continuous processing
Who Should Attend
Management, production, and development engineers,
production managers, development chemists, process
development, validation, and quality professionals,
automation and engineering professionals, professionals
interested in PAT/ QbD/PQLI®
ISPE Communities of Practice (COPs)
API and PAT
Speakers to Date
• Theodora Kourti, PhD, Senior Technical Director,
GlaxoSmithKline, UNITED KINGDOM
• David McAlonan, Associate Director, Abbott Laboratories, USA
• Sarah Mancini, Senior Manager / TL Mfg Technology - API,
Pfizer, USA
• Steve Hammond, Director/Team Leader, Process
Analytical Sciences Group, Pfizer Global Manufacturing, USA
407 - Biotech Hot Topics: Capacity, Single-Use,
and Gaskets
9 November 14.15-17.15
ISPE CEUs: 0.25
ISPE’s Biotech COP will showcase best-in-class
presentations made at the Chapter and Affiliate level. Topics
www.ISPE.org/2010AnnualMeeting
17
are selected based on their timeliness and importance
to the biotech community, as judged by the Steering
Committee of the COP. This year is focused on long term
strategy but also addresses the hot topic of gasket material
selection.
•B
iomanufacturing Capacity: The Bottleneck Moves
Downstream: The industry is struggling to rebalance
upstream and downstream processing. Why and how?
Implication on world capacity?
•Bugs on Wheels: Advances in single-use processing
steps are shifting the way that the industry thinks about
capital investment in manufacturing facilities. Is this the
technology of the future? What are the issues?
•E
PDM Gaskets – What Debate? With careful consideration,
and good polymer engineering, the performance of seals
for such applications can reach new heights. Extractables,
performance, and manufacturing regimes and testing will
be discussed.
Leader
• Tom Moss, Biotech COP Steering Committee, President,
Applied Process Solutions, Inc., Hingham, MA, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Analyze implications of high titer fermentation
• Describe capacity analysis
• Explain what is driving the debottlenecking of downstream
processing and emerging technologies to address this
• Discuss what is driving the emphasis on single-use
manufacturing systems and the implications single-use
systems have on future plant design
• Understand the “great debate on gasket materials”
Who Should Attend
Plant, general, quality, maintenance, financial and operation
managers, manufacturing and process engineers, and
capacity planners
18
www.ISPE.org/2010AnnualMeeting
ISPE Communities of Practice (COPs)
Biotech
Speakers to Date
• Tom Ransohoff, VP Bioprocess Technology Consultants,
USA
• Parrish Galliher, Founder & Chief Technology Officer,
Xcellerex, USA
• John Toynbee, Senior Development Technologist, James
Walker & Company Limited, UNITED KINGDOM
408 - The Science of Project Management (PM):
Real Time Project: Build a Lab
(Highly interactive, two-part session; please register
for both 308 and 408)
Sponsored by the ISPE Project Management Community of
Practice
9 November 14.15-17.15
ISPE CEUs: 0.25
See session 308 for details.
501 - Offshoring of Chemical and
Pharmaceutical R&D towards Asia: Status Quo,
Insights, Risks, and Opportunities
10 November 08.15-12.15
ISPE CEUs: 0.35
The centre of global pharmaceutical industry is shifting and
offshoring of chemical and pharmaceutical R&D to Asia
is challenging all companies. In order to understand the
phenomenon, we need to understand and examine:
• The reasons, drivers and necessity for Big Pharma to
go East
• How to select the right partners
• The importance and benefits for clinical R&D
• Intellectual property risks
• Different organizational models
• Cross-cultural aspects
Additionally, the importance goes far beyond cost saving and
includes issues such as shortening cycle times, tapping into
talent pools in India and China, penetrating new, emerging,
and huge markets as well as developing products for local
markets in close proximity to customers. Furthermore,
offshoring suggests a powerful tool to cope with the current
productivity challenges in multinational Big Pharma.
Leader
• Frank Floether, VP Business Development Asia-Pacific,
Johnson & Johnson Global Chemical & Pharmaceutical
Development (retired), now Dr. Floether Consulting,
SWITZERLAND
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand rationale for Big Pharma R&D to go East
• Learn about opportunities and risks in key countries like
India, China and Singapore
• Understand operating models for doing R&D in Asia
Who Should Attend
R&D employees, management, decision makers;
regulatory; managers from chemical and pharmaceutical
manufacturing, QA/QC and project managers; everybody
who is confronted with current challenges in pharma
R&D, cost saving needs and with the ambition to assist in
penetrating new markets
ISPE Communities of Practice (COPs)
API, IP, OSD, PAT, PM, and PPD
Speakers to Date
• Ramendra Pandey, Retired Research Fellow and Technical
Team Leader for Outsourced Projects, USA
502 - Calibration Management: A Risk-Based
Approach
Sponsored by the ISPE GAMP® Community of Practice
10 November 08.15-12.15
ISPE CEUs: 0.35
Calibration is an essential element to ensure success. If
neglected, calibration is capable of compromising both
product and plant, and dramatically increasing costs. This
session will provide guidance in setting up a calibration
management system which will give a structured, riskbased, approach required to set up instrument risk, impact
and criticality assessment, management, documentation
and corrective actions essential to regulatory compliance.
It will cover production, process, and system/laboratory
instrumentation. The process of setting up clear
procedures and carrying out formal criticality assessment
will allow calibration activities to be managed to
concentrate resources where they are most needed. This
interactive session will demonstrate a pragmatic approach,
based on a criticality assessment, to provide effectiveness
and regulatory compliance as cost effectively as possible.
Leader
• Mark Foss, Sciurus Consultancy, Formally Head of
Engineering, Boehringer Ingelheim Ltd., UNITED KINGDOM
How You Will Benefit
At the end of this session, participants will be able to:
•U
nderstand the regulatory requirements for calibration
• Focus calibration effort concentrating on regulatory risks
and patient safety
• Apply information from internal and external auditing of
systems and the use of supplier systems and documentation
•A
pply errors of uncertainty calculations and assumptions
• Understand physical labeling and tagging schemes
• Utilize risk based interval setting
• Interpret reference standards and traceability, as well as
tolerance, alert and action limits
• Analyze adjustment (within range, out of range)
Who Should Attend
Regulators, plant designers, QA compliance and auditors,
compliance document control managers, engineering
managers, control and instrument engineers, calibration
and control technicians
ISPE Communities of Practice (COPs)
C&Q, CU, ESB, GAMP®, HVAC, and PM
504 - Dosage Form Manufacturing: New Process
Technology
Sponsored by the ISPE Oral Solid Dosage Community of
Practice
10 November 08.15-12.15
ISPE CEUs: 0.35
Are you aware of the latest improvements in Oral Solid
Dosage (OSD) process technology? This session will review
and compare technologies that dramatically impact the
way dosage forms are made featuring proven innovations,
as well as blue sky technologies. The OSD Community
of Practice (COP) is calling for presentations on the ISPE
website:
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand the latest developments in OSD manufacturing
• Apply advanced manufacturing process while
maintaining compliance
Who Should Attend
Operations, engineering/maintenance, quality, and
safety professionals
ISPE Communities of Practice (COPs)
Containment, CU, HVAC, OSD, and PAT
Program Committee Members
• Jeffrey Biskup, President, CRB Consulting Engineers, Inc., USA
• Paul Egee, Product Manager, IMA North America, USA
• Robert Matje, Senior Director, Pfizer, USA
• Sunil Chand Singhai, Vice President, Dr Reddy’s
Laboratories Ltd., INDIA
• Stephen Sirabian, Executive Vice President, Glatt Air
Techniques Inc., USA
www.ISPE.org/cs/communities_of_practice_
section/communities_of_practice_overview
505 - Clinical Manufacturing Implementation of
ASTM E 2500-07
Leader
This session will present case studies on the application
of ASTM E 2500-07 for effective change. One case study
will present how Amgen’s Clinical Operations, responsible
for quickly and efficiently moving clinical products
through the development pipeline while complying with
regulatory requirements, leveraged the verification process
outlined by the ASTM E 2500-07, thus tailoring the clinical
operating standard and SOPs and introducing the use
of engineering-owned business practices for verification
activities which resulted in a net reduction in the number
of SOPs. By establishing formal verification business
Selection will be reviewed by Subject Matter Experts who
are COP leaders. Where practical there will be show and
tell sessions so delegates can interface with technology.
The call-for is primarily interested in the following, but other
subjects are also welcome: direct compression, continuous
blending and fluidizing process, advanced PAT, and
continuous release technology application.
• Jack Chu, PE, Manager, Merck & Co Inc., USA
10 November 08.15-12.15
ISPE CEUs: 0.35
www.ISPE.org/2010AnnualMeeting
19
practices describing good engineering practices and
defining an appropriate level of quality unit involvement,
the organization cultivated cultural change and encouraged
staff to collaborate more closely, placing responsibility for
activities with the appropriate function or group. Based on
historical clinical projects, the new process is designed to
deliver savings in time and labor.
Leader
• Patricia Stewart-Flaherty, M.Sc., CQA, Senior Advisor,
Regulatory & Quality Affairs, Health & Human Services
ASPR/BARDA, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Describe the strategy and procedure by which Clinical
GMP systems are verified
• Outline the key principles of Clinical Manufacturing
Verification (CMV)
• Delineate the roles and responsibilities within Clinical
Operations, as well as requirements and deliverables
• Explain how implementation of ASTM E 2500-07 can
be effectively applied to reduce effort and streamline
verification activities
506 - GAMP® Good Practice Guides: Updates
You Can Use
10 November 08.15-12.15
ISPE CEUs: 0.35
This session will present case studies from several GAMP®
Good Practice Guides (GPGs) followed by small group,
interactive discussions, based on topics of interest to
attendees in the room. Participants will learn which GPGs
are currently being updated and why, current hot topics,
and small group discussions will be facilitated by GAMP®
Subject Matter Experts (SMEs). Through this process,
participants needs and discussion will be taken into
consideration as potential content and topics for future
Good Practice Guides.
Leader
•K
evin Martin, Vice President, CimQuest Vantage LLC, USA
How You Will Benefit
Validation, quality assurance, facilities, engineering, and
operation professionals
At the conclusion of this session, participants will be able to:
•O
utline the subject matter covered by GAMP® Good
Practice Guides
• Understand their applicability to your company’s needs
• Incorporate the ideas from GPGs in their company
procedures and day to day operations
• Identify opportunities to participate in a GAMP® Special
Interest Group to help shape future projects and guidance
ISPE Communities of Practice (COPs)
Who Should Attend
Who Should Attend
C&Q and ESB
Speakers to Date
• Gregory Tewalt, PhD, Director Quality Assurance,
Amgen Inc., USA
• Nicholas Haycocks, Principal Engineer, Amgen Inc., USA
Engineers, validation engineers, quality, computer
system developers
ISPE Communities of Practice (COPs)
GAMP
®
Program Committee Members
• GAMP® Steering Committee Members and GAMP®
SIG Members
20
www.ISPE.org/2010AnnualMeeting
• Michael Rutherford, Quality Consultant - Lab Informatics,
Global Quality Labs, Eli Lilly & Co., USA
• Arthur D. Perez, PhD, Executive Expert, QA, Novartis
Pharmaceuticals Corporation, USA
507 - Sustainable Design of Critical Utilities:
Innovative Processes and Applications
Sponsored by the ISPE Critical Utilities Community of
Practice
10 November 08.15-12.15
ISPE CEUs: 0.35
This session will feature case studies on innovative
processes and new applications for existing technologies
in critical utilities systems. Presentations will focus on
real world examples on the application of new technology
and process, sustainable design and conservation of
raw materials, and retrofit projects for existing systems.
Equipment end of life, disposable technologies, and
equipment reuse will also be discussed.
Leader
• Andrew Collentro, Technical Director, Water Consulting
Specialists, Inc., USA
How You Will Benefit
At the end of this session, participants will be able to:
• Execute cost reduction strategies
• Explore hidden costs within critical utility systems
• Maximize efficiency of existing processes
Who Should Attend
Design, process, and utility/facility engineers and
project managers
ISPE Communities of Practice (COPs)
Biotech, CU, PM, SF, and SPP
508 - The Science of Project Management:
Construction Partnering
Sponsored by the ISPE Project Management Community of
Practice
10 November 08.15-12.15
ISPE CEUs: 0.35
Partnering is a controversial process heavily utilized in
public sector construction projects and to a degree in
our industry between owners and contractors involved
in construction projects. Think outside the box as we
use video to inform and educate PMs about partnering
while focusing in on risks and benefits for both owners
and contractors. We’ll visit a project team involved in a
construction project with, and without, partnering. We’ll
visit team members as they are engaged in partnering
workshops and will explore both a smooth and rough
project completion (lessons learned). We will present
interviews conducted with people experienced in
partnering. A secondary purpose will be to demonstrate
the use and value of video as an educational tool. We
plan on “measuring” comprehension and retention of the
information provided. Additionally, we will explore the use of
web based interactive training. Join us for this unusual type
of learning opportunity.
Leaders
• Leo Hura, Commercial Mediator, Retired, USA
• Keith Gibbs, Corporate Manager, C&Q, Yonkers Industries, USA
How You Will Benefit
At the end of this session, participants will be able to:
• Define and discuss the elements of partnering
• Identify the risks and benefits of partnering
• List lessons learned from those exploring construction
partnering innovations
Who Should Attend
API, Biotech, C&Q, OM, and PM
ISPE Communities of Practice (COPs)
PM
700 - Investigational Products – A Magical
Journey to Explore Reality, Retooling and
Growth
Sponsored by the ISPE Investigational Products Community
of Practice
Monday 8 November 13.30-17.00
Tuesday 9 November 08.15-11.30
Tuesday 9 November 14.15-17.15
Wednesday 10 November 08.15-12.15
ISPE CEUs: 12.25 ACPE Credits
The three days of Investigation Products education
sessions at the ISPE Annual Meeting will address topics
covering challenges that industry professionals face in their
day-to-day lives, as well as a crystal ball look into potential
changes in the pharma industry and how it may impact the
planning and execution of clinical supplies. Sessions include
a variety of presentation types and opportunities to discuss
and interact so that participants may provide their own
perspectives as well as take away actionable solutions.
General Sessions will bring everyone together and will be
anchored by the keynote on What IP Professionals Should or
Could do Differently Tomorrow.
Sessions include:
• Identifying, hiring and creating clinical supply wizards
• Challenges of integrating two supply chains, a 360 degree
review from industry and contractor perspectives
• Application of Lean Six Sigma in a clinical supply
organization
• Successes and challenges in the quest to have expiry
dates removed from clinical labels
• Getting more done with less in a changing environment
(identifying processes and tools we are going to need)
•D
ealing with emergencies and the magic required to work
through them
• New tools and sprinkling fairy dust to enhance “old ones”
(IVRS standards)
• Obtaining support and funding for software tool
acquisition and implementation
• What happens when others cast spells on clinical supplies
(i.e. regulatory, distribution and customs changes of
“Epcot” proportions)
• Single source comparator strategies for global studies
• Clinical perspective on use of clinical supplies at sites
• Update of EMA positions on GMP/GCP interface and
Annex 13
A favorite, the wildcard discussion, will focus on questions
from workshop, case study topics, keynote, and attendee
questions and interests.
Join these three days of intensive offerings that can benefit
your company and your practice. Learn about how the
ISPE Investigational Products Community of Practice can
continue to help you online and throughout the year. In
addition to the education opportunities, attend special
networking events just for clinical professionals.
Leader
• Neal Gordon, Director, Schering-Plough Research
Institute, USA
How You Will Benefit
At the end of this session, participants will be able to:
• Discuss the benefits and risks of strategically entering
emerging or new markets
• Evaluate tools/solutions for forecasting and managing
clinical supplies
• Address challenges and duty implications faced in
importing clinical supplies
• Optimize the client-vendor relationships
• Advance supply chain capabilities and performance
www.ISPE.org/2010AnnualMeeting
21
Who Should Attend
Investigational products professionals from all levels of the
pharmaceutical, biotechnology industry, pharmaceutical
companies, generics, and third party vendors.
ISPE Communities of Practice (COPs)
IP and Packaging
Program Committee Members
• Timothy Brewer, Vice President Global Logistics, Fisher Clinical
Services Inc., USA
• Kristen DeVito, Director of Operations, Aptuit Inc, USA
• Matthew Gilson, Computer Systems Compliance Manager,
GlaxoSmithKline, USA
• Kunal Jaiswal, Director, Global Clinical Supply, Schering-Plough
Corporation, USA
•M
ichael Ku, PharmD, VP, Clinical Pharmacy Services, Genzyme
Corp., USA
• Steven Yoder, Director, Clinical Trial Materials Management, Eli
Lilly & Co., USA
Certified Pharmaceutical Industry
ProfessionalTM (CPIPTM) Certification Program
Workshops
Introduction Workshops
8 November 13.30-14.30
9 November 08.30-09.30
These complimentary, one hour workshops provide an
overview of the CPIPTM, a pharmaceutical industry focused,
international competency-based credential made available
through the ISPE Professional Certification Commission.
Topics include: CPIPTM introduction, eligibility criteria, and
the application and examination processes explained.
How-to Workshops
8 November 15.00-16.00
9 November 10.30-11.30
9 November 14.00-15.00
10 November 09.00-10.00
These complimentary, one hour workshops provide
guidance on how to submit a CPIPTM eligibility application
and prepare for the CPIPTM examination. Topics include:
obtaining a university transcript, completing the
professional experience forms, using the CPIPTM Study
Guide resources, and organizing CPIPTM study groups.
Learn more about this certification program at
www.ISPE-PCC.org.
What is the CPIPTM certification program?
The Certified Pharmaceutical Industry ProfessionalTM
credential is for industry professionals around the
world working in and supporting product development
through manufacturing.
How can Becoming a CPIPTM help me?
• Professional development – acquisition of
knowledge and skills
• Industry-wide recognition – enhanced credibility
• Career advancement – increased opportunities
Benefits of Certification
The Certified Pharmaceutical Industry ProfessionalTM
program…
• Establishes standards of competency for
pharmaceutical industry professionals
• Assesses the competences (knowledge and skills)
demonstrated by pharmaceutical professionals
• Encourages growth and innovation in the
pharmaceutical industry
• Formally recognizes individuals who meet the
requirements established by ISPE PCC
• Serves the public and pharmaceutical industry
employers by improving the competence, quality,
and effectiveness of pharmaceutical professionals
• Contributes to pharmaceutical industry innovation
How do I get it?
Anyone working in the pharmaceutical industry can
apply.
1. Apply for and obtain eligibility
2. Prepare for the exam
3. Apply for, take, and pass the exam
22
22
www.ISPE.org/2010AnnualMeeting
Basic Principles of Computerized Systems
Compliance: Applying the GAMP® 5 Guide:
A Risk-based Approach to Compliant GxP
Computerized Systems (T07)
9-10 November 2010
Tuesday 08.00-17.00, Wednesday 08.00-15.30
ISPE CEUs: 1.3
Level: Fundamental
Course Description
This fundamental course introduces participants to
regulatory requirements for computerized systems in
the pharmaceutical industry and explores tried, tested,
and internationally recognized methods of meeting those
requirements. GAMP guidance provides a pragmatic and
effective framework for achieving computerized systems
that are fit for intended use and meet current regulatory
requirements, by building upon existing industry good practice
in an efficient and effective manner. The course does not aim
to cover detailed and highly technical aspects of software
and hardware engineering, but rather gives the principles
and an overview of the overall computer systems compliance
process, including a scaleable and efficient system lifecycle,
Quality Risk Management applying ICH Q9, updated GAMP
categories, supplier assessment, and the selection of
appropriate specification and verification activities.
Course topics include:
• W
hat are the US FDA and EU regulatory requirements for
GxP computerized systems?
• How do investigators approach a computer systems
inspection?
• O
verview of GAMP® 5 Guide: A Risk-based Approach to
Compliant GxP Computerized Systems
• GAMP system lifecycle and specifications - URS, FS, and
design
• Key themes and concepts
• Quality Risk Management for computerized systems
• Computerized system validation framework - plans and
reports
• Risk Assessment method
• S
calable specification and verification based on risk
• U
pdated GAMP Categories
• Role of users and suppliers - assessment and cooperation
and leveraging supplier activities and documentation
• T
esting in GAMP - principles and practical approaches
• Verification approaches and qualification terminology and
concepts
• P
olicies, procedures, and plans required for effective
governance
• P
ragmatic and efficient practices - cost effective
compliance
• New special interest topics, including control of
spreadsheets and end-user databases
• O
peration, control, and maintenance of systems
This course was developed by members of the ISPE GAMP
Community of Practice. GAMP was established by industry
leaders to interpret and improve the understanding of
regulations governing the use of computerized systems in
pharmaceutical manufacturing.
Immediately apply the course objectives using the
complimentary copy of GAMP® 5: A Risk-Based Approach to
Compliant GxP Computerized Systems.
Take Back to Your Job
• E
xplain the regulatory requirements and expectations
for computerized systems used in pharmaceutical
manufacturing
• Apply GAMP principles to specific systems and cases
• Describe the GAMP approach to computerized system
compliance
• Apply these ideas to systems within your own organization
Attendance Suggested For
• Q
uality assurance and quality control specialists, validation
specialists, manufacturing supervisors, technical support
personnel, engineers, MIS professionals and all levels of
management who need a fundamental understanding of
computerized system compliance and regulations
• Computer system vendors or consultants, engineering
contractors, and validation service companies
Community of Practice (COP)
www.ISPE.org/COPs
This training course is of particular interest to existing and future
members of the ISPE GAMP Community of Practice (COP).
CPIP™ Technical Knowledge and Competency Elements
Some courses contain knowledge related to the
CPIP™ Technical Knowledge and Competency Elements. For
complete information concerning the knowledge elements or
the CPIP™ Credential, please visit www.ISPE-PCC.org. The
ISPE Professional Certification Commission does not endorse
any of these resources, products, or services offered relative
to the CPIP certification program.
Instructor
Sion Wyn, Director, Conformity Ltd., is an
acknowledged expert in computer system
validation and compliance and international
regulations in this field. He is currently
assisting the FDA with its re-examination of
21 CFR Part 11, and is a member of the team
that produced the FDA Guidance on 21 CFR
Part 11 Scope and Application. He is the
technical content expert for the FDA’s ORA Virtual University
online training modules on computerized systems validation
and compliance. He has received the FDA Group Recognition
Award for work on Part 11. Wyn is the editor of ISPE’s
GAMP® 5 Guide - A Risk-Based Approach to Compliant GxP
Computerized Systems, and is a member of the ISPE GAMP
Council, GAMP Editorial Board, and the GAMP Europe Steering
Committee. At Conformity Ltd., Wyn provides computer
validation and compliance consultancy to the pharmaceutical
and other regulated healthcare industries. Wyn received the
2006 ISPE Professional Achievement Award, which honours an
ISPE Member who has made a significant contribution to the
pharmaceutical manufacturing industry.
www.ISPE.org/2010AnnualMeeting
23
Cleaning Validation Principles (T17)
9-10 November 2010
Tuesday 08.30 - 17.00, Wednesday 08.30 - 17.00
ISPE CEUs: 1.3
Level: Intermediate
Course Description
As cleaning technology and detection methodology advance,
so do the challenges associated with establishing, managing,
and maintaining a scientifically sound cleaning validation
program. US FDA’s risk-based regulatory initiatives focus new
attention on the risks of cross-contamination. The solution
is to understand life cycle management techniques for an
effective cleaning validation program.
This course will cover elements of a cleaning validation
program from start to finish, exploring such concepts as
the determination of residues to be targeted, selection
of analytical and sampling methods, determination
of appropriate limits in various pharmaceutical and
biotechnology processes, and establishment of scientific
rationales acceptable to regulatory inspectors. For
mature cleaning validation programs, concepts such as
understanding process control, capability, learning to
effectively self-audit a cleaning validation program, and
documentation will be essential takeaways.
Take Back to Your Job
• Identify and characterize potential residues including
product, processing aids, cleaning agents, and
adventitious agents
• Apply appropriate analytical methodology for selected
residues
• Determine suitable sampling techniques and the selection
of sampling locations that present a challenge for the
cleaning process
• Calculate residue limits that meet all necessary regulatory
requirements
• C
reate scientifically sound rationales, validation protocols,
and reports
• Manage the challenges of multi-product facilities in
the establishment of limits, determination of validation
24
www.ISPE.org/2010AnnualMeeting
strategies, and maintaining the validated state
• U
nderstand campaign-based production strategies for
effective and scientifically sound validation
• Differentiate the requirements for cleaning validation when
using manual, semi-automatic, and automatic cleaning
technologies
• Determine scientific grouping or bracketing approaches
• Comprehend the pitfalls inherent in cleaning after the
production of biopharmaceutical and pharmaceutical
products
• Accomplish analytical method validation and recovery
study requirements in cost-effective studies that provide
the necessary assurance of an analytical system
• Evaluate cleaning practices, limit calculations, scientific
rationales, and validation documents through internal
self-audits to ensure compliance with ever-changing
regulatory needs
• P
ractice hands-on exercises designed to reinforce core
competencies and job-focused skills
Attendance Suggested For
• P
rofessionals responsible for all aspects of cleaning
validation programs, including development, deployment,
and maintenance
• Quality assurance specialists, quality control technicians,
regulatory affairs professionals, pharmacologists and
toxicologists, validation scientists, and validation service
personnel
• Manufacturing supervisors, technical support personnel,
and engineers responsible for evaluating cleaning systems,
reviewing equipment, and supporting the cleaning
validation program on the plant floor
• All levels of management who need to understand the
science of cleaning and cleaning validation including
the aspects of residue selection, sampling method
and analytical detection method validation, limits
determination, and strategies for managing multi-product
facilities
Instructor
Rebecca Brewer has more than 18 years
experience in validation and compliance within
the pharmaceutical, biopharmaceutical and
medical device industries. She joined Dober
Group as Director, Consultancy Services,
Validation and GMP Compliance in order to
provide Dober’s cleaning chemical customers
with cleaning validation consultation and
general compliance and validation assistance. Prior to
joining Dober, Becky was a senior consultant with Raytheon
Engineers & Constructors’ Validation Services Department
(now Washington Group). As a consultant, Becky has had
the opportunity to audit, develop and provide training in
validation and compliance programs for a large variety of
companies and products. Becky’s work in cleaning validation
has led to the development of procedures and policies in
some of the most challenging environments, including:
potent compound facilities, isolation suites, research and
development, contract manufacturers and suppliers. Becky
is the instructor for the ISPE Cleaning Validation Course and
is a frequent instructor for University of Wisconsin, IVT and
Barnett. Prior to joining Raytheon, Becky worked for
Bristol-Myers Squibb in New Brunswick, New Jersey where
she participated in the development of their cleaning
validation program, supervised the validation microbiology
laboratory and conducted computer system validation,
among other activities. Becky has specific expertise in
cleanroom design and construction, aseptic processing,
isolation technology, cleaning and sterilization.
North American
Education
Committee and
Annual Meeting
Task Team
Allan Pfitzenmaier
NAEC Chairman
President
Vectech Pharma Consultants Inc., USA
Grace Chin
Annual Meeting Task Team Chair
Senior VP, BioPharmaceuticals
SNC-Lavalin Pharma, CANADA
Deepak Agarwal
Director, Pharma Technology
Jacobs Consultancy, USA
Paul Crissman
Principal
Biotechnical Solutions, USA
Donna DeFreitas
Senior Associate
Genesis Engineers Inc., USA
Michael Denault
Tampa Conference Chairman
Principal
Denault Associates, USA
Daniel Franklin
Regional Compliance Manager
IPS, USA
Keith Gibbs
Corporate Manager, C&Q
Yonkers Industries, USA
Michelle Gonzalez
BioPharm Engineering/Consultant,
USA
Gerard Guillorn
Vice President
Structure Tone Inc., USA
John Hannon
Principal, Computer Systems
Commissioning Agents Inc., USA
Mark Hannon
Senior Compliance Specialist
Genentech, USA
Timothy Howard, PE, CPIP
NAEC Immediate Past Chairman
Director, Commissioning/Validation
Commissioning Agents, Inc., USA
James John
Project Manager
Altus Automation, USA
Remitha Jones
Manager, Operations Engineering
Services
Abbott Molecular, USA
Gary Knight
Project Manager
Commissioning Agents, Inc., USA
Daniel Lachapelle
President
Lachaps, CANADA
Stephan Orichowskyj
Washington Conference Chairman
Director Biotechnology
CDI Life Sciences, USA
Patricia Stewart-Flaherty, MSc,
CQA
Senior Advisor, Regulatory
& Quality Affairs
Department of Health & Human
Services ASPR/BARDA, USA
Cheryl Tucker
Alliance Management
Eli Lilly & Co., USA
Stephen Williams
Director
Seer Pharma Pty Ltd., AUSTRALIA
Call for Hot Topics
Due 30 June 2010
Do you have a hot topic for a session at Annual Meeting?
Several time slots have been saved for late breaking ideas.
Submit yours by downloading form at www.ISPE.org/
CallForProposals and submit to gphillips@ISPE.org with
the subject line Hot Topic Proposal.
Call for Poster Presentations
Due 30 June 2010
What is a Poster Presentation?
More Online
The ISPE 2010 Annual Meeting
Brochure includes program details
and presenters at the time of
printing. Additional presenters
and important new program
additions will be available at www.
ISPEorg/2010AnnualMeeting
as they are confirmed. Visit often for
the latest information.
Posters present information pictorially and with written
documentation. They are an effective means of sharing
a new application or approach, a creative solution, or a
collaboration that worked.
Eligibility
Professionals from the pharmaceutical, biotechnology or
medical device industry, and university faculty and graduate
students submit abstracts for review. Abstracts are reviewed
for sound technical content and avoidance of commercial
intent. Submissions will be accepted from any ISPE Member
or professional in the pharmaceutical industry or academia.
Review Criteria
Technical relevance, merit, organization, clarity, and
avoidance of commercial intent.
How to Submit and More Information,
www.ISPE.org/PosterProposal
Posters are featured at the Tuesday afternoon and
Wednesday morning break times.
www.ISPE.org/2010AnnualMeeting 25
Easy Steps to Register for Networking Events
Option 1: Online Registration - Get registered for all ISPE
2010 Annual Meeting Networking Events online at www.
ISPE.org/2010AnnualMeeting or Option 2: Fax, Email,
or Mail the Guest and Networking Events Registration Form
on page 30 with payment information, and return to ISPE via
fax, email, or mail (fax: +1-813-264-2816; email: ask@ispe.
org; mail: 3109 W. Dr. Martin Luther King Jr. Blvd., Ste. 250,
Tampa, Florida, 33607 USA).
Sunday Welcome Reception in the Exhibit Hall
Greetings and salutations! All 2010 Annual Meeting delegates
are invited to the Exhibit Hall on 7 November to network over
hors d’oeuvres and catch up with old friends and meet new
ones. More than 250 suppliers will be on hand to answer
questions and share industry knowledge. Don’t miss out;
sponsorship opportunities are available.
Special Guests: FOYA Category Winners
Representatives from each of the 2010 Facility of the Year
Award-winning companies will also be in attendance at the
Sunday Welcome Reception to discuss their innovative
facilities and celebrate their achievements with attendees. Be
sure to stop by the Facility of the Year Awards booth in the
Exhibit Hall to meet them.
ISPE 2010 Communities of Practice Night
Monday, 8 November
COP Night Beach Bash and General Reception
17.30-19.00
Price: US$20 (not included with any package fees)
Join us at the Beach for ISPE’s third annual COP Night.
Attendees can network with friends and colleagues sharing
similar interests while enjoying tasty appetizers and cold
drinks, and relaxing along the white sand beach of the Swan
and Dolphin Resort.
ISPE’s 19 Communities of Practice (COPs) are teaming up to
offer attendees an experience customized to their interests.
26
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www.ISPE.org/2010AnnualMeeting
Participating COPs include: Active Pharmaceutical
Ingredients, Biotechnology, Commissioning and Qualification,
Containment, Critical Utilities, Disposables, Engineering
Standards Benchmarking, GAMP®, Good Control Laboratory
Practices, HVAC, Investigational Products, Operations
Management, Oral Solid Dosage, Packaging, Process
Analytical Technology, Process/Product Development,
Project Management, Sterile Products Processing, and
Sustainable Facilities.
Register for Networking Events on the Guest and Networking
Events Registration Form found on page 30, or online at
www.ISPE.org/2010AnnualMeeting. Guests may also
register for these events using this form.
Registration for the COP Night Beach Bash General Reception
is required. The Guest and Networking Events Registration
Form can be found on page 30 of this brochure or at www.
ISPE.org/2010AnnualMeeting in the networking
section.
Get to know your fellow ISPE Members over food, drinks,
and fun! Visit www.ISPE.org/2010AnnualMeeting for
details. Sponsorship opportunities available.
COP Night Beach Bash General Reception
Sponsorship Opportunities
We do not have a formal Guest program this year. You are
invited to register for the Sunday Reception, Monday COP
Reception, Monday COP Dinner, Tuesday Night Party, and/
or the Wednesday lunch with the delegates. Registration
on page 30. There are many options for things to do in the
Orlando area including Disney theme parks, shopping, and
other activities. Disney discounted ticket information is on
page 26. See the concierge for more options. (Stop by ISPE
Registration to put your name on a contact list so other
guests can get in touch with you.)
ISPE’s COP Night Reception provides exclusive, cost
effective, and targeted sponsorship opportunities. Contact
John Phillips at jphillips@ispe.org or Valerie Adams at
vadams@ispe.org for specific details.
COP Night Dinners
19.30-21.30
Price: US$70 (not included with any package fees)
At the conclusion of the COP Night Beach Bash General
Reception, several COPs will offer Annual Meeting attendees
a customized social dinner event. The evening offers
attendees an opportunity to dine at two of the hotel’s
signature restaurants. Attend the GAMP® and Engineering
Standards Benchmarking COP Dinner at Shula’s Steak House
in the Dolphin Resort or the Active Pharmaceutical
Ingredients, Biotechnology, and PAT COP Dinner at Todd
English’s Blue Zoo. Look for a list of participating COPs online
when registering for your favorite COP Dinner.
Registration for the COP Dinners is required. Register
for either of these COP Night Dinners at www.ISPE.
org/2010AnnualMeeting in the networking section or
on page 30.
Tuesday Night Party
Tuesday, 9 November
19.00-22.00
Price included in Full Education Delegate Fee. A la carte:
US$200 (includes dinner and entertainment)
Guests
Career Solutions Onsite
Attention Job Seekers, the ISPE 2010 Annual Meeting Career
Solutions Job Board features job postings, and you may have
the opportunity to meet with prospective employers who are
exhibiting at the event.
Employers, gain exposure to a highly-targeted and
experienced audience – all 2010 Annual Meeting delegates,
students, speakers, committee volunteers, and exhibitors. A
variety of featured employer packages are available. Please
visit www.ISPE.org/CareerSolutions to view Featured
Employer packages for this event or contact Valerie Adams
at vadams@ispe.org for more information.
Unemployed Members
If you are unemployed, but would like to attend the
conference to network with other professionals, contact
Member Services for details about options available to you.
Email memberservices@ispe.org or call +1-813-960-2105.
Cyber Café (Sponsored by Commissioning
Agents, Inc.)
Access the Internet at the Cyber Café located in the Exhibit
Hall - open during exhibit hours (see page 26).
Volunteer Lounge
Volunteers are vital to the success of ISPE and we greatly
appreciate your dedication and support as an ISPE Volunteer.
In recognition of your commitment, we invite you to join us in
the Volunteer Lounge, available exclusively to ISPE Volunteers.
Downloads
Visit the Downloads Page at
www.ISPE.org/2010AnnualMeeting to view
registration forms, the delegate roster (available 20
October), presentation handouts, exhibitor forms, and more.
ISPE Knowledge Center
of distinguished industry judges and attendees are able to
view the posters throughout the meeting. ISPE announces
the international graduate and undergraduate winners at
the Annual Meeting Membership Luncheon and Awards
Ceremony on Tuesday, 9 November.
Winners receive a monetary prize and recognition in
ISPE publications. Participants have the opportunity to
publish an article based on their poster presentations in
Pharmaceutical Engineering magazine. Visit www.ISPE.
org/CampusConnection for details.
Young Professionals’ Schedule
Sunday, 7 November
12.30-15.00
Young Professional Lunch/Orientation with Industry Speakers
15.00-16.00
Student Poster Set Up
Monday, 8 November
13.30-17.00
Student Poster Competition
19.30-22.00
Young Professionals’ Networking Event (off-site)
The ISPE Knowledge Center offers details on ISPE
Membership, joining a COP, the CPIPTM certification program,
future Annual Meetings, and local interests and activities. While
you are there, also visit the ISPE Bookstore where you will
receive a 20% discount onsite as an ISPE Member. An ISPE
staff person will be available to answer all of your questions.
Tuesday, 9 November
11.45-13.45
Membership Luncheon and Awards Ceremony
• Student Poster Competition Winners Announced
• Student Chapter of the Year Announced
14.00-17.00
Affiliate/Chapter/Student Chapter* Workshops for North and
South America/Europe/Asia Pacific
Young Professionals at Annual Meeting
Affiliate/Chapter Council Activities
Annual Meeting offers many opportunities for you to meet
and greet other industry professionals and students, learn
about industry trends, and make valuable connections to
boost your career potential.
Sunday, 7 November
08.30-11.30
North America South America Affiliate Council Meeting
Open Sunday afternoon to Wednesday
ISPE International Student Poster Competition
Student poster finalists from around the world showcase
visual displays of their research or program highlights. These
talented Student Members present their work before a panel
Keynote Session
Monday, 8 November
08.30-12.00
The ISPE 2010 Annual Meeting Keynote Session features three
exciting speakers from a variety of backgrounds. See page 3
for details.
Membership Luncheon and Awards Ceremony
Tuesday, 9 November
11.45-13.45
It’s time to thank those who made incredible achievements
in 2010 and to look ahead to 2011. Hear ISPE leadership and
colleagues provide insights on Society accomplishments and
look ahead to 2011 goals. Special recognition awards will
be presented to Members, Affiliates, Chapters, committees,
companies, authors, and students.
Charity 5K Run/Walk (Sponsored by Belimed)
Sunday, 7 November
07.00
Plan your travel to participate in the ISPE 2nd Annual Charity
5K Run/Walk (3.1 miles). “5K for 5K” - Help us raise US$5,000
for Doctors Without Borders/Médecins Sans Frontières (MSF).
Doctors Without Borders/Médecins Sans Frontières (MSF) is
an international medical humanitarian organization. The event
is for the whole family. Register online or use the Guest and
Networking Events Registration Form on page 30.
New Member/First Time Attendee
Orientation Breakfast
Monday, 8 November
07.00 – 08.15
New Members and first-time attendees are cordially invited to
this special networking breakfast hosted by the Membership
Development Committee (MDC). Meet fellow Society Members
and Annual Meeting attendees to foster new relationships; learn
about ISPE and how to make the most out of your membership.
Bring plenty of business cards for this high-impact networking
event! Please be sure to sign up on the 2010 Annual Meeting
Delegate Registration Form.
Monday, 8 November
13.30-17.00
Joint Affiliate Councils’ Meeting - North and South America/
Europe/Asia Pacific
www.ISPE.org/2010AnnualMeeting 27
Event
Tuesday, 9 November
About Orlando
Swan and Dolphin Resort
In the heart of the Walt Disney World® Resort, the
award-winning Walt Disney World Swan and Dolphin is
the gateway to Central Florida’s greatest theme parks
and attractions. The resort is located in between Epcot ®
and Disney’s Hollywood Studios™ and near Disney’s
Animal Kingdom® Theme Park and Magic Kingdom® Park.
Complimentary scheduled transportation to Walt Disney
World® Theme Parks and attractions, including water taxis
to Disney’s Hollywood Studios™, Epcot ®, and Disney’s
BoardWalk entertainment district is also available.
Discounted Disney Park Tickets
Advance purchase of specially priced Disney Meeting/
Convention Theme Park tickets is available at www.
disneyconventionear.com/ISPE. Orders must be
in advance by 7 November.
There’s an App for That
The Walt Disney World Swan and Dolphin recently
developed two iPhone Apps featuring information about
the resort and restaurants. The Resort iPhone App and
the Restaurant iPhone App are available for download at
www.swandolphin.com/aboutus/iphone.html.
08.30-11.30
Asia Pacific Affiliate Council Meeting
11.45-13.45
Membership Luncheon and Awards Ceremony
14.00-17.00
Affiliate/Chapter/Student Chapter* Workshops for North and
South America/Europe/Asia Pacific
Sunday, 7 November 17.00-19.00
Monday, 8 November 07.00-16.15
Tuesday, 9 November 07.00-11.00
*Student Chapter Workshops are for Faculty and Industry
Advisors and Affiliate/Chapter/Student Affairs Chairs;
optional for Students
How to Register
Showcase Your Products and Services
at the Table Top Exhibition
Want to get noticed? Showcase your products and services at the
ISPE Annual Meeting Table Top Exhibition. Attended by thousands of
industry and regulatory leaders, this is a “must-attend” event. Gain
access to and interact with key decision makers and buyers from
the global pharmaceutical and biotech manufacturing industry.
ISPE is the world’s largest not-for-profit association dedicated
to educating and advancing pharmaceutical manufacturing
professionals. The ISPE Annual Meeting attracts professionals from
a wide range of disciplines, including facility engineers/managers,
project engineers/managers, process engineers, manufacturing
engineers, validation and quality professionals, as well as regulatory
affairs, computer and process control personnel, scientists,
operations, and investigational products professionals.
The price for each table top is US$2,950 and includes two
complimentary exhibitor badges. The two complimentary
exhibitor badges include access to continental breakfasts,
refreshment breaks, the Sunday Welcome Reception held in the
Exhibit Hall, and the Monday lunch. Additional exhibitor badges are
available for purchase. Contact John Phillips at jphillips@ispe.org
or Valerie Adams at vadams@ispe.org to reserve a space.
Only registered sponsors, exhibitors, committee members,
speakers, education delegates, or guests may walk through
the Exhibit Hall.
We no longer offer exhibit walk through badge.
28
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www.ISPE.org/2010AnnualMeeting
Exhibit Hall Hours
The Sunday Welcome Reception, Continental breakfasts,
vendor sessions, and breaks are in the Exhibit Hall. Stop
in for a great opportunity to network with colleagues and
suppliers.
Education delegates, committee members, speakers,
government and university faculty, and ISPE Student
Members may register:
Online: Visit www.ISPE.org/2010AnnualMeeting
Via Fax: Complete the registration forms in this brochure
and fax to: +1-813-264-2816
Via Mail: Complete the registration forms in this brochure
and mail with payment to: ISPE Headquarters, 3109 W. Dr.
Martin Luther King Jr. Blvd., Ste. 250, Tampa, Florida 33607 USA
Questions? Call ISPE Member Services,
tel: +1-813-960-2105 or email: ask@ispe.org
Payment must be included with registration; complete credit
card information is required for all registrations. We accept
American Express, VISA, or MasterCard. Payments made by
check must be in US dollars and drawn on a US bank. Wire
transfers are accepted - please contact ISPE for details. Hotel
accommodations are not included in the registration fee.
Full conference registration includes access to all four days of
conference educational sessions, continental breakfast, breaks,
lunches (Monday – Wednesday), Sunday Welcome Reception, and
the Tuesday Night Party. Alternately, you may also purchase a
one-day pass to attend daytime education on Sunday, Monday,
Tuesday, or Wednesday. The one-day pass does not include
evening events, which may be purchased a la carte.
Information
Hotel Accommodations, Information and
Reservations
Headquarters Hotel
The Swan and Dolphin Resort is the headquarters hotel for
the ISPE 2010 Annual Meeting. ISPE reservations will be at
the Dolphin.
Airport Transportation
The closest airport to the Swan and Dolphin Resort
is the Orlando (MCO) Airport – 22.1 mi/35.6 km –
about 28 minutes. Discount transportation from
the airport can be organized though https://
secure.mearstransportation.com/Default.
asp?Referrer=380772079 and select the Dolphin
Swan and Dolphin Resort
1500 Epcot Resorts Blvd, Lake Buena Vista, FL 32830 USA
Tel: +1-407-934-4000, Fax: +1-407-934-4884
Disney Hotel. This shuttle makes stops at other hotels on the
way to the Dolphin hotel.
Reservations need to be made through ISPE.
Guests can enjoy the convenience of on-site car rental
service through National and Alamo. Located in the guest
services area of the Dolphin, guests can make arrangements
for automobile pickup and drop-off. Contact National Car
Rental at 1-800-CAR-RENT or Alamo at 1-800-GO-ALAMO.
www.swandolphin.com
The Swan and Dolphin Resort offers ISPE meeting attendees
a discounted hotel rate of US$269 (resort fee included). This
rate is good until 7 October 2010 or until the room block is full,
whichever comes first. In order to qualify for the discounted
ISPE hotel rate, each delegate must be fully registered for the
Annual Meeting as an education delegate, active committee
member, speaker, or exhibitor. See Hotel Registration Form on
page 28 for more information. Cancellation fees apply.
Please be advised that ISPE has only one contracted hotel
for the ISPE 2010 Annual Meeting. We urge you to make all
room reservations for the ISPE 2010 Annual Meeting through
the ISPE Web site, or by faxing or mailing ISPE Headquarters
directly (Fax: +1-813-264-2816; Mail: ISPE Headquarters, 3109
W. Dr. Martin Luther King Jr. Blvd., Suite 250, Tampa, Florida
33607 USA). This will secure you the ISPE rate at the hotel
as well as help ISPE to fulfill its rooming commitment to the
Swan and Dolphin Resort. The Resort Service Package is $10
per day and is included in the ISPE rate. The Resort Service
Package offers the following: up to 60 minutes free local
telephone calls, toll free and credit card access calls (.10 cents
per minute after 60 minutes); 20 minutes of domestic long
distance per day; unlimited access to the resort’s health club
facilities; in room high-speed Internet access; and 2 bottles of
water daily.
Hotel Parking
Self parking is US$11 and valet US$18 for overnight guests.
For those not staying at the hotel, parking is US$12 for self
parking and valet US$15 for each time parking.
National and Alamo Car Rental Desk
Disney Transportation
Complimentary scheduled transportation to Walt Disney
World® Theme Parks and attractions, including water taxis
to Disney’s Hollywood Studios™, Epcot ®, and Disney’s
BoardWalk entertainment district, is also available.
Dress is Business Casual
Education Program and Exhibit Badge
Cancellations
Education program and exhibit badge cancellations will
be accepted only in writing. If received by 18 October
2010, a full refund, minus a 10% handling fee (maximum of
$100) will be issued. No refunds after that time. Telephone
cancellations will not be accepted.
Education Handouts
Registered Education Delegates will have online access to
session handouts for a limited time before and after Annual
Meeting. Reminders will be emailed. If you wish to take notes
directly on handouts, we recommend you print handouts prior
to your arrival.
Notice Regarding Speakers
Speakers selected to present programs are leading
professionals in their fields. However, it may be necessary to
make substitutions. If so, every possible effort will be made to
substitute a speaker with comparable qualifications. Agendas
are subject to change without notice. Every precaution
is taken to ensure accuracy, but ISPE cannot accept
responsibility for information distributed or contained in the
programs or for any opinion expressed.
All ISPE Annual Meeting delegate functions are business casual.
The evening functions are casual. Typical autumn weather in
Orlando calls for high temperatures around 78°F/25°C and lows
around 57°F/13°C. Temperatures in meeting rooms tend to be
cool, so bring a light jacket or sweater.
ACPE CEUs
Substitutions
ISPE CEUs and Accreditation
Substitutions for education delegates are accepted and
may be made by contacting ISPE in writing. Nonmembers
substituting for Members are required to pay the difference in
all Member fees.
Exhibit Cancellations
Exhibit cancellations must be made in writing. Any cancellation
made on or before 5 September 2010 will result in a US$1,000
fee. Exhibitors are responsible for the full Table Top fees for
cancellations made in writing after 5 September 2010.
ACPE CEUs are awarded only for educational offerings
that relate to Investigational Product topics. Application
for these credits is pending. Please check www.ISPE.
org/2010AnnualMeeting for updates.
ISPE provides ISPE Continuing Education Units (CEUs).
These nationally-recognized units of achievement have been
designed for those individuals continuing their education in
their chosen fields or professions. Delegates will receive ISPE
CEU certificates six to eight weeks following the program.
ISPE has been named a continuing education provider by the
Florida Board of Professional Engineers. Although ISPE is not
an American Institute of Architects (AIA) continuing education
provider, AIA members may submit their ISPE conference
sessions by completing the Self-Report Form located on the AIA
Web site, www.aia.org.
www.ISPE.org/2010AnnualMeeting
29
Please Send This Form To ISPE
FAX: +1-813-264-2816
MAIL: ISPE, 3109 W. Dr. Martin Luther King Jr. Blvd., Suite 250,
Tampa, Florida, 33607 USA
Official Hotel Headquarters for
ISPE 2010 Annual Meeting
Swan and Dolphin Resort
All reservations must be made through ISPE.
The Swan and Dolphin Resort offers ISPE meeting attendees
a discounted hotel rate of US$269 (resort fee included). This
rate is good until 7 October 2010 or until the room block is full,
whichever comes first. In order to qualify for the discounted
ISPE hotel rate, each delegate must be fully registered for the
Annual Meeting as an education delegate, active committee
member, speaker, or exhibitor.
How to Make a Hotel Reservation
1. Use a credit card and register completely online for the
event at www.ISPE.org/2010AnnualMeeting.
Once you have registered for the event online, you will receive a confirmation email. You may then make your hotel reservations through the link provided in the email.
2. Or, mail or fax your reservation request with credit card
information to ISPE, or send a check or money order covering
the first night’s stay (US$302.63 including taxes) drawn on a
US bank and payable to Swan and Dolphin Resort.
ISPE 2010 Annual Meeting Hotel Reservation Request Form
Hotel accommodations will book fast! Early registration is strongly recommended.
This form will not be processed unless preceded or accompanied by an ISPE Annual Meeting Registration Form.
Reservation requests need to be sent to ISPE directly, and not the hotel.
Official Meeting Dates: Sunday, 7 November to Wednesday, 10 November
Group rate valid three days before and after event. For other dates, contact ISPE.
Primary Attendee:
Name (print)________________________________________________________ISPE ID #___________________________________
Email Address_____________________________________________________ Company____________________________________
Please reserve one (1) room for _____________ people for Arrival on __________________ Departure on _____________________
Room Type Preferred:
Handicapped
King Bed
Double Beds (all rooms non-smoking)
Estimated Time of Arrival _______________________________________
Please notify us in writing if you have any special requirements.
We encourage you to make your hotel reservation
immediately upon receiving your confirmation email (an
acknowledgement email will be sent to you when your
reservation is received). Changes may be made by following
the directions from your hotel acknowledgement email. If
contacting ISPE with changes, please send them in writing.
There is a processing period for all reservations from ISPE into
the hotel system. Please do not contact the hotel regarding
your reservation until after 15 October 2010. A confirmation
email will be sent by the hotel after 15 October 2010.
Address_______________________________________________________________ City ______________________________________
Nonrefundable Deposit
Expiration Date______________________________________________________________________________________________
A deposit of one night (US$302.63 including taxes) is required
to hold your room reservation and is nonrefundable after 13
October 2010. Credit cards will be charged one night as of 14
October. Please complete the credit card information in full.
ISPE has only one contracted hotel for the ISPE 2010
Annual Meeting. We urge you to make all room reservations
for the ISPE 2010 Annual Meeting at www.ISPE.
org/2010AnnualMeeting or by fax or mail to ISPE
Headquarters directly. This will secure you the ISPE rate at
the hotel, as well as help ISPE to fulfill its contracted rooming
commitment to the hotel.
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30
www.ISPE.org/2010AnnualMeeting
State/Province___________________ Zip+4/Postcode _______________Country _________________________________________
Tel ______________________________________________________________ Fax _________________________________________
Name(s) of person(s) sharing accommodations________________________________________________________________________
Credit Card Type________________________________ Credit Card Number______________________________________________
I authorize the Swan and Dolphin Resort to charge my account for one night’s deposit plus applicable taxes as of 13 October.
Signature_________________________________________________________________________________
Signature is required in order to be processed.
Swan and Dolphin Resort will not accept any reservations sent directly to them. If you would like to pay by check, please contact
ISPE Member Services to make arrangements, tel: +1-813-960-2105, or email ask@ispe.org.
Cancellation Policy for the Swan and Dolphin Resort
Guests cancelling their stay after 15.00, 24 hours prior to check in, will be charged their full stay.
Please note that if you do not arrive on the first day of your room reservation, the Swan and Dolphin Resort will charge you a
no-show fee equal to one night and may not have a hotel room available when you arrive. Please remember to contact the
hotel if you are delayed.
ISPE 2010 Annual Meeting Education Delegate Registration
Attach Hotel Reservation Request Form and Guest and Networking Events Registration Form, and submit both
to ISPE. Photocopy to register additional people.
Please type or print clearly.
Check here if you were previously an ISPE Member.
ISPE ID # _______________________________________________
First Name _______________________________________MI___________Last Name_________________________________
Informal Badge Name ______________________________Chapter/Affiliate__________________________________________
Job Title______________________________________________ Email Address_______________________________________
Company______________________________________________ Business Address_____________________________________
State/Province________________________ Zip+4/Postcode_________________________ County_______________________
Business Tel____________________________________________ Business Fax_______________________________________
ONLINE: www.ISPE.org/2010AnnualMeeting
FAX: +1-813-264-2816
MAIL: ISPE, 3109 W. Dr. Martin Luther King Jr. Blvd., Suite 250, Tampa, Florida, 33607 USA
Emergency Phone: Cell Phone _______________________________ or Home Phone________________________________
FULL EDUCATION FEES
No refunds after
18 October
On/Before After
11 October 11 October
(T07) GAMP (T17) Cleaning
Pricing Shown as On or Before
11 October and After 11 October
TOTAL
US$
I wish to keep my data confidential and it is given
only for use by ISPE and its local Chapters and
Affiliates.
I do not wish my information to be printed in the
Membership Directory or on Conference Attendee
Listings.
Current Member
$1,400
$1,700
$1,510/ $1,810
$1,410/ $1,710
$
New Member
(Fee includes oneyear ISPE Membership, a $215 value)
$1,615
$1,915
$1,725/ $2,025
$1,625/ $1,925
$
Nonmember
$1,695
Committee
$ 750
I’m a new ISPE Member.
$2,010
$1,810/ $2,125
$1,705/ $2,020
$
$
PLEASE SELECT SEMINARS OF CHOICE
308 - Real Time Project (Part 1 of 2)
Government
$ 850
$755
$755
$
CPIPTM Certification Program Introduction Workshops
Tues 08.30-09.30
(Complimentary) Mon 13.30-14.30
CPIPTM Certification Program How-to Workshops
Tues 10.30-11.30
(Complimentary) Mon 15.00-16.00
Tues 14.00-15.00 Weds 09.00-10.00
700 - Investigational Products (Part 2 of 4)
Emerging Economy
$ 700
$755/ $905
$705/ $855
$
Academia Member
$ 700
$755/ $905
$705/ $855
$
Student Member
$ 475
$755/ $905
$705/ $855
$
Sunday, 13.00-17.00
401 - Working with Emerging Markets
402 - Disposable Technologies
403 - Advanced Aseptic Processing
101 - Global Trends R&D Facilities
404 - Facility of the Year (2)
102 - Hygienic Systems
405 - PQLI®: Product Design, Development, Realization
103 - Sustainable Facilities
406 - Advanced Process Monitoring
104 - Operational Excellence
407 - Biotech: Capacity, Single-Use, Gaskets
105 - Construction Quality
408 - Real Time Project (Part 2 of 2)
106 - Nanotechnology
108 - Science of PM: Consistent Terminology
Monday, 13.30-17.00
700 - Investigational Products (Part 3 of 4)
Wednesday, 08.15-12.15
501 - Offshoring R&D Towards Asia
Keynote Session - Mon 08.30-12.00
502 - Calibration Management
201 - HVAC cGMP Trends
504 - Dosage Form Manufacturing
202 - Sterile Manufacturing Faciliites
505 - Implementation of ASTM E 2500
203 - Managing Commissioning
506 - GAMP® Good Practice Guides
204 - Regulatory Town Hall Forum
507 - Sustainable Design Critical Utilities
205 - Water for Injection
206 - C&Q Forum: Risk-Based Approach
208 - Science of PM: PCSI
700 - Investigational Products (Part 1 of 4)
Tuesday, 08.15-11.30
508 - Science of PM: Construction Partnering
700 - Investigational Products (Part 4 of 4)
Wednesday, 12.45-15.45
602 - Hot Topic (TBD)
603 - Hot Topic (TBD)
301 - GAMP® Outsourcing
302 - Designing a cGMP Facility in China
303 - Managing Cleaning Validation
Tuesday, 14.15-17.15
CANCELLED
304 - Facility of the Year (1)
605 - Hot Topic (TBD)
606 - Hot Topic (TBD)
Training Tuesday and Wednesday (Single day fees do not apply)
305 - PQLI®: Pharma Quality Systems
Basic Principles of Computerized Systems Compliance (T07)
306 - Pharmaceuticals in the Environment
Cleaning Validation (T17)
Early Bird
11 October
FULL DAY EDUCATION MEAL FUNCTIONS
Full delegate registration includes all events listed below, plus the Sunday
Welcome Reception, continental breakfasts, and breaks. Please check
functions you plan to attend so that we can arrange for sufficient meals.
I will not attend any meals, receptions, or parties
I will attend the New
Monday Lunch
Member/First-time ISPE
Tuesday Membership Lunch and Awards Ceremony
Annual Meeting Attendee
Tuesday Party
Orientation Breakfast
Wednesday Lunch
on Monday. Details page 25.
Special Meal Requirement
Kosher
Vegetarian
Gluten Free
SINGLE DAY FEES*
Sun. to Weds., check
days you will attend.
On or Before
11 October
After 11 October
TOTAL
US$
Half Day
Sunday
Member
$ 255
*Nonmember $ 295
Member
$ 305
*Nonmember $ 345
$
One Day
Monday
Tuesday
Wednesday
Member
$ 485
*Nonmember $ 575
Member
$ 585
*Nonmember $ 675
$
1 1/2 Day
Sunday/Monday
Member
$ 740
*Nonmember $ 870
Member
$ 890
*Nonmember $1,020
$
Two Day
Monday/Tuesday
Tuesday/Weds
Member
$ 970
*Nonmember $1,150
Member
$1,170
*Nonmember $1,350
$
2 1/2 Day
Sun/Mon/Tues
Member
$1,225
*Nonmember $1,445
Member
$1,475
*Nonmember $1,695
$
PAYMENT METHOD
Registrations only accepted with payment or credit
card information. Please contact ISPE regarding wire
transfers.
Substituting for______________________________
If you are a nonmember substituting for a
Member, the nonmember registration fee is
required in advance.
Check #____________________________________
enclosed payable to ISPE (US Dollars only, drawn
on a US bank) in the amount
of $ ___________
Bill My Credit Card - Circle Type:
VISA
MASTERCARD
AMEX
_____________________________________________
CArd Number
_____________________________________________
Expiration Date
_____________________________________________
Name of Cardholder (as it appears on card)
SINGLE DAY EDUCATION MEAL FUNCTIONS
Single day fees include continental breakfast, lunch, and breaks for the days
registered. The Tuesday Night Party must be purchased a la carte. Please check
functions you plan to attend so that we can arrange for sufficient meals.
I will not attend any meals, receptions, or parties
I will attend the New
Monday Lunch
Member/First-time ISPE
Tuesday Membership Lunch and Awards Ceremony
AM Attendee Orientation
Wednesday Lunch
Special Meal Requirement
I’m a first-time ISPE Annual Meeting attendee.
Kosher
Vegetarian
Breakfast. Details page 25.
Gluten Free
Tues Party
$200
$
Tues Lunch/Awards (Non Delegate/Committee Member)
$50
$
TOTAL US$ $
_____________________________________________
Cardholder Signature
*Join ISPE now and save! Visit
www.ISPE.org/Join to learn about the
benefits of membership.
Cancellations must be made in writing.
Refunds will be given minus a 10% handling fee
(maximum of $100) if received on or before 18
October. No refunds thereafter.
Please send Annual Meeting
registration and hotel reservation forms with
payment to: ISPE Headquarters
3109 W. Dr. Martin Luther King Jr. Blvd., Suite 250
Tampa, Florida 33607, USA
Tel: + 1-813-960-2105, Fax: +1-813-264-2816
www.ISPE.org - FEIN #59-2009272
31
ISPE 2010 Annual Meeting
Guests
Guest and Networking Events Registration Form
Please type or print clearly.
Member ID: ________________________________________________
Primary Attendee
First Name ___________________________________________________MI____________Last Name_________________________________________________
Email Address___________________________________________________________________________
Job Title___________________________________________________________ Company __________________________________________________________
We do not have a formal Guest program this year. Use this form for
the Sunday Reception, Monday COP Reception, Monday COP Dinner,
Tuesday Night Party, and/or the Wednesday lunch with the delegates.
There are many options for things to do in the Orlando area including
Disney theme parks, shopping, and other activities. Disney discounted
ticket information is on page 26. See the concierge for more options.
(Stop by ISPE Registration to put your name on a contact list so other
guests can get in touch with you.)
Business Address_______________________________________________________________________________City____________________________________
State/Province_______________________________________________ Zip+4/Postcode___________________________Country _________________________
Business Tel______________________________________________________Business Fax__________________________________________________________
Emergency Phone: Cell Phone ______________________________________________or Home Phone________________________________________________
Guest 1 Name __________________________________________________________________Email__________________________________________________
Guest 2 Name __________________________________________________________________Email__________________________________________________
Payment Method
Registrations will not be accepted without payment or credit
card information. Please contact ISPE regarding wire transfers.
Check #____________________enclosed payable to
ISPE (must be in US Dollars, drawn on a US _bank) in the amount of
$ ________________________
Bill My Credit Card - check type:
PLEASE SELECT THE EVENT(S) YOU WILL ATTEND
FEE
Charity 5K Run/Walk (Sunday morning)
$25
each
$0
each
Monday Night COP Beach Bash General Reception, 17.3019.00 at the Beach
includes beer, wine, soft drinks, appetizers, and
Community Networking Activities
$20
each
*Monday Night COP Dinner Events, 19.30-21.30
(Choose only one event)
GAMP® and Engineering Standards Benchmarking
COP Dinner
Shula’s Steak House (Dolphin Resort) – includes appetizer,
entrée, dessert, beer, wine, and soft drinks
$70
Sunday Night Reception
QTY TOTAL
Wednesday Delegate/Guest Lunch
each
www.ISPE.org/2010AnnualMeeting
AMEX
_____________________________________________________________
Card Number
_____________________________________________________________
Expiration Date
______________________________________________________________
Name of Cardholder (as it appears on card)
_____________________________________________________________
FEI #59-2009272
Please submit your hotel reservation form on page 28 with this form.
Cancellations accepted in writing. Refunds will be given minus
a 10% handling fee (maximum of $100) if received on or before
18 October. No refunds thereafter.
Please send Annual Meeting registration and hotel reservation
$200 each
$45 each
Total US$ __________
32
MASTERCARD
Cardholder Signature
Active Pharmaceutical Ingredients, Biotechnology,
PAT COP Dinner
Todd English’s Blue Zoo (Dolphin Resort) – includes salad or
appetizer, entrée, dessert, beer, wine, and soft drinks
Tuesday Night Party
VISA
forms with payment to:
ISPE Headquarters
3109 W. Dr. Martin Luther King Jr. Blvd., Suite 250
Tampa, FL 33607 USA
Tel +1-813-960-2105, Fax +1-813-264-2816
www.ISPE.org
*If minimum number of guests is not met, individual
COP Dinner Events may be cancelled. Please
register early or the dinner events may have to be
cancelled 60 days prior to the event.
Host Sponsor
Lanyard Sponsor
Annual Meeting Sponsorships
Foster New Business, Offer Targeted Messages,
Get Your Business Noticed!
COP Night Sponsor
Platinum Sponsors
Hotel Key Cards Sponsor
5K Charity Run/Walk Sponsor
As an Annual Meeting sponsor, ISPE provides the resources
and relationships that guarantee your company a wide
exposure to key decision makers in pharmaceutical and
biotech manufacturing, with a minimum investment of your
time and personnel. ISPE’s knowledgeable sales force
gives you the flexibility to customize a program that works
for you. We offer a range of sponsorship opportunities
designed to build greater brand awareness, strengthen your
company image, and increase your exhibit traffic.
Sponsorships available include Platinum, Gold, Silver, and
Bronze as well as specialty item sponsorships for tote bags,
exhibit hall giveaways, room drops, and much more. Other
opportunities include Communities of Practice (COP) Night
on Monday, 8 November. COP Night offers unparalleled
exposure to a targeted audience providing cost-effective
sponsorship. Additional onsite advertising opportunities are
available.
Contact John Phillips at jphillips@ispe.org or Valerie Adams
at vadams@ispe.org to secure your sponsorships.
Exhibit Hall Give-Away Passport Sponsors
Cyber Café Sponsor
www.ISPE.org/2010AnnualMeeting 33
NOVATION
3109 W. Dr. Martin Luther King Jr. Blvd.,
Suite 250 | Tampa, FL 33607
NON-PROFIT ORG.
U.S. POSTAGE
PAID
TAMPA, FL
PERMIT NO. 2661
www.ISPE.org/2010AnnualMeeting