ISPE
Annual Meeting
www.ISPE.org/annualmeeting
Thriving In A Survival Environment
8 - 11 November • Manchester Grand Hyatt San Diego • San Diego • California, USA
Exhibit and Sponsorship Opportunities Available
LAST UPDATED 6 May 2009
ISPE 2009 Annual Meeting
Table of Contents
Affiliate/Chapter
Council Activities..............................................27
Annual Meeting Tracks....................................4-6
Career Café.......................................................26
COP Night Activities..........................................25
CPIPTM Workshops.............................................24
Education Schedule.............................................7
Education Sessions........................................8-24
Exhibit Information...........................................27
Event Highlights..........................................26-27
General Information.........................................28
Hotel Reservation Form....................................30
Keynote Session................................................26
Membership Benefits...........................................3
Networking Events............................................25
Poster Presentations.........................................24
Registration Form.............................................29
Registration Information...................................28
Student Activities........................................26-27
Sponsorships....................................................31
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Thriving in a Survival
Environment
In this brochure we proudly present this year’s selection
of education sessions and other can’t miss events
taking place at 2009 Annual Meeting, 8-11 November,
San Diego, California, USA.
Our theme is Thriving in a Survival Environment,
and this sentiment, as well as Annual Meeting itself,
represents what ISPE is about, and what ISPE does
better than any other industry association.
Year after year, ISPE builds upon its primary goal to
provide tools and to share knowledge across silos to
help our industry be more streamlined and efficient
(lean/mean/green). Best practices come directly from
ISPE Members and nonmembers working in the field
each day, and ISPE continues to maintain a strong
base of input and influence incremental industry
changes despite challenges that may arise in our global
economies.
Our Annual Meeting education sessions, keynote
addresses, and critical events allow us to share ways
to work smarter and to thrive, even when in survival
mode. You may find that you need ISPE now more than
ever, and we hope you join us in San Diego.
Registration details and up-to-date information on our
education sessions are also online at
www.ISPE.org/annualmeeting.
Sincerely,
Charles Hoiberg, PhD
Pfizer
Chair, ISPE Intl. Board of Directors, 2008-2009
It’s Easy to Register
Education Delegates
Review this brochure or visit www.ISPE.org/
annualmeeting to select the sessions you would like
to attend.
Then register by completing the Delegate and Hotel
Registration Forms at the back of this brochure and
returning them to ISPE with payment. Visit www.ISPE.
org/annualmeeting to register online.
Exhibiting Companies
Register to exhibit at www.ISPE.org/annualmeeting/
exhibits. Exhibiting companies will receive
confirmation packets by email. These confirmation
packets will include badge, floor plan, and hotel
registration forms.
Annual Meeting Goes Greener
ISPE and the Manchester Grand Hyatt, San Diego, are
working to make 2009 Annual Meeting the greenest
ISPE meeting yet. Steps to reduce our carbon footprint
include:
• Electronic program materials and handouts will
replace paper and be accessible at the Annual
Meeting Web site
• We are providing the 2009 Annual Meeting
Networking Brochure as a downloadable PDF on
the Annual Meeting Web site rather than printing
• Lanyards are made from recycled materials, and a
recycle area will be available for attendees who
wish to recycle lanyards and tote bags
• The Grand Hyatt: recycles all paper, plastic,
aluminum, glass, and cardboard; offers voluntary
towel and sheet reuse program to guests; uses
biodegradable, non-toxic cleansers; and sends
food donations to San Diego Food Bank
North American
Education Committee
and Annual Meeting
Task Team
Deepak Agarwal
Director Pharma Technology
Jacobs Consultancy, USA
Alessandro Anzalone, PhD, NASAAC
Director, Chemical Engineering
Polytechnic University of Puerto Rico,
USA
Mark Butterworth
Project Manager
GlaxoSmithKline, CANADA
Grace Chin
Washington Conference Task Team
Leader
Senior Vice President
Science & Technology
SNC-Lavalin Pharma, CANADA
Paul Crissman
NAEC Immediate Past Chairman
Principal
Biotechnical Solutions, USA
Daniel Franklin
Regional Manager Compliance Services
IPS, USA
Stephan Orichowskyj
Director, Biotechnology
CDI Life Sciences, USA
Keith Gibbs
Corporate Manager Technical
Services, C&Q
Yonkers Industries, USA
Allan Pfitzenmaier
Annual Meeting Task Team Leader
and NAEC Co-Chairman
President
Vectech Pharma Consultants Inc. ,
USA
Michelle Gonzalez
BioPharm Engineering/Consultant, USA
Jerry Guillorn
Vice President
Structure Tone Inc., USA
Mark Hannon
Senior Compliance Specialist
Genentech, USA
Timothy Howard, PE, CPIP
NAEC Chairman
C&Q Business Lead
Commissioning Agents, Inc., USA
Kunal Jaiswal
Director Global Clinical Supply
Schering-Plough Corporation, USA
Jim John
Project Manager
Altus Automation, USA
Joseph De Paul
President
Skye Technical Services, USA
Remitha Jones
Principal Engineer
Abbott Laboratories, USA
Donna DeFreitas
Senior Associate
Genesis Engineers Inc., USA
Gary Knight
Project Manager
Commissioning Agents, Inc., USA
Mike Denault
Tampa Conference Task Team Leader
Principal
Denault Associates, USA
Jeffery Odum
Education Advisor
Principal
NCBioSource, USA
Andrew Signore, PE, CPIP
CEO
IPS, USA
Cheryl Tucker
Alliance Management
Eli Lilly & Co., USA
Rebecca Waterbury
Regulatory Compliance International
Abbott Vascular, USA
Stephanie Wilkins, PE
ISPE Board Liaison
President
PharmaConsult US Inc., USA
More Online
The ISPE 2009 Annual Meeting
Education Brochure includes
program details and presenters to
date. Additional presenters and
important new program
additions will be available at
www.ISPE.org/annualmeeting as
they are confirmed. Visit often
for the latest information.
Your Membership Benefits
As an ISPE Member, you have access to the tools and
resources you need to not only survive, but to thrive in
these tough economic times. Whether you need to increase
your knowledge or skills, collaborate with like-minded
professionals, or further develop your career and build your
business, ISPE can help. Leverage your ISPE membership
benefits to meet your individual needs:
Knowledge
ISPE’s content-rich Body of Knowledge provides timely and
critical information, and innovative solutions:
• Hear from global regulators and industry leaders
• Increase your knowledge and skills via ISPE events
and online learning
• Research solutions with technical documents and
publications
Community
Whether through face-to-face meetings or virtual
communities, there are numerous opportunities to form
professional relationships that enable an open exchange
of ideas and communication:
• Meet Members in your local area through your Affiliate or Chapter
• Participate in Communities of Practice to network
and collaborate with professionals in your area of expertise
• Search the Membership Directory to find
Members for one-on-one relationship building
Profession
Developing your career is a lifelong pursuit, and ISPE has the
tools you need to support your professional advancement
throughout your career:
• Certified Pharmaceutical Industry ProfessionalTM
certification program
• Volunteering at ISPE
• Career Exchange for employment opportunities
Learn more about your ISPE membership benefits by visiting
www.ISPE.org/Members. ISPE … Your Society of Choice.
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ISPE 2009 Annual Meeting Tracks
Track Descriptions
Survival Track
Product Development
Please use the track listing to help locate which
sessions may be of interest to you. Education sessions
fall into multiple tracks so you may see them listed
more than once.
The theme of this year’s ISPE Annual Meeting is Thriving in a
Survival Environment. ISPE education sessions are created by
ISPE Members who work every day in the same environment
that you work and face similar challenges. As Volunteers,
ISPE Member presenters bring their good ideas to the Annual
Meeting table sharing knowledge, insight and application
through these education sessions, aiming to strengthen the
pharma environment through this medium. This track has a lot
to offer! Sessions include:
(CPIP Knowledge Element 1)
Track Color Guide
Used online at www.ISPE.org/annualmeeting.
Survival
Product Development
Facilities and Equipment
Information Systems
Supply Chain Management
Production Systems
Regulatory Compliance
Quality Systems
Investigational Products
Project Management
Supplier-Focused
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• 103 - Combination Products: Considerations for
Entering a New Market
• 104 - Risk Assessment and Risk Management
• 106 - Logistics: Follow the Money/Material and
the Impact on Unit Pricing
• 201 - Case Study: LEAN within Quality Assurance/
Quality Control at H. Lundbeck A/S
• 203 - Survival - From Manufacturer’s Perspective
• 207 - Profitability through Sustainable Design
[Green = Profit]
• 303 - Ensuring the Integrity of the Global Supply Chain
• 404 - Anticounterfeiting – Can Chemistry Trump Bureaucracy?
• 405 - Driving Improvement for Bioprocessing Operations
• 407 - The Ever-changing Face of the Bio-Contract
Manufacturing World
• 502 - Sustainability for Biotech Processes
• 505 - Continuous Pharmaceutical Manufacturing
– Opportunities Now and in the Future
• 506 - Sustainable Projects for Existing Facilities
[Green = Profit]
• 604 - Meeting Regulatory Need: The Challenge
for Generics and CMOs and the Risk of Ignoring
Warning Letters
• 606 - 21st Century Approaches for Reducing
Manufacturing Costs During a Global Economic Crisis
• And all of Project Management: 108 - Case Studies,
208 - Project Conceptualization, 307 - Better Project
Results Through Innovative Collaboration and Outsourcing,
308 - Project Design, 408 - Project Construction, 508 - Project
Commissioning and Qualification, and 608 - Project
Operations
CPIP knowledge element one includes (1) formulation, clinical
phases, and manufacture, (2) technology transfer, and (3)
production scale-up and optimization. Sessions in this track
feature content in these areas. Sessions include:
• 102 - New Technologies in OSD
• 103 - Combination Products: Considerations for
Entering a New Market
• 104 - Risk Assessment and Risk Management
• 201 - Case Study: LEAN within Quality Assurance
/Quality Control at H. Lundbeck A/S
• 203 - Survival - From Manufacturer’s Perspective
• 206 - Process Analytical Technology (PAT) Used
for PQLI® and QbD: Implementation Update, Examples, and Discussion
• 207 - Profitability through Sustainable Design
[Green = Profit]
• 301 - Quality and Regulatory Challenges Relating
to Development, Use, and Approval of Drugs for
Medical Countermeasures
• 401 - A Seamless Approach for Technology Transfer
• 405 - Driving Improvement for Bioprocessing Operations
• 502 - Sustainability for Biotech Processes
• 505 - Continuous Pharmaceutical Manufacturing
– Opportunities Now and in the Future
• 606 - 21st Century Approaches for Reducing
Manufacturing Costs During a Global Economic Crisis
Facilities and Equipment
(CPIP Knowledge Element 2)
CPIP knowledge element two includes (1) design
and construction/installation, (2) commissioning and
qualification as a risk management strategy, (3) operation
and maintenance, and (4) controls and automation. Sessions
include:
• 101 - Facility of the Year Category Award Winner
Presentations
• 104 - Risk Assessment and Risk Management
ISPE 2009 Annual Meeting Tracks
• 202 - Case Study: Cephalon Master Plan and Renovation of Corporate R & D Headquarters, Westchester, PA, USA
• 204 - Good Engineering Practice
• 207 - Profitability through Sustainable Design
[Green = Profit]
• 302 - C&Q COP Pharma Manufacturers Risk Approach Task Team Forum
• 304 - Case Studies in Contained Active Pharmaceutical Ingredients (API) Pilot and Manufacturing Facilities
• 402 - Disposable Manufacturing Strategies, Impact on Design, Operations and the Environment
• 405 - Driving Improvement for Bioprocessing Operations|
• 502 - Sustainability for Biotech Processes
• 504 - The New NIH Design Requirements Manual
for State-of-the-Art Biomedical Research Facilities
• 505 - Continuous Pharmaceutical Manufacturing
– Opportunities Now and in the Future
• 602 - Critical Utilities – Guides, Hot Topics, and Sustainable Design
• And all of Project Management: 108 - Case Studies,
208 - Project Conceptualization, 307 - Better Project
Results Through Innovative Collaboration and Outsourcing,
308 - Project Design, 408 - Project Construction, 508 - Project
Commissioning and Qualification, and 608 - Project Operations
Information Systems
(CPIP Knowledge Element 3)
Sessions include:
• 403 - Infrastructure Compliance Lifecycle
• 503 - Dispelling the Part 11 Myths
• 603 - Life After GAMP® 5: What Comes Next?
Supply Chain Management
(CPIP Knowledge Element 4)
CPIP knowledge element four includes (1) materials
management, (2) operational economics, and (3) warehouse
and distribution management. Sessions include:
• 106 - Logistics: Follow the Money/Material and
the Impact on Unit Pricing
• 203 - Survival - From Manufacturer’s Perspective
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• 303 - Ensuring the Integrity of the Global Supply Chain
• 402 - Disposable Manufacturing Strategies, Impact on Design, Operations and the Environment
• 404 - Anticounterfeiting – Can Chemistry Trump
Bureaucracy?
• 407 - The Ever-changing Face of the Bio-Contract
Manufacturing World
• 700 - Investigational Products – Innovation in a
Regulated Environment
Regulatory Compliance Includes
Drugs, Environmental, Health and
Safety
Production Systems
• 103 - Combination Products: Considerations for
Entering a New Market
• 205 - Regulatory Hot Topics - Town Hall Forum
• 206 - Process Analytical Technology (PAT) used
for PQLI® and QbD: Implementation Update, Examples, and Discussion
• 301 - Quality and Regulatory Challenges Relating
to Development, Use, and Approval of Drugs for
Medical Countermeasures
• 302 - C&Q COP Pharma Manufacturers Risk
Approach Task Team Forum
• 303 - Ensuring the Integrity of the Global Supply Chain
• 305 - Product Quality Lifecycle Implementation (PQLI®)
• 306 - Validation Master Plan Benefits, Application,
and Case Studies
• 406 - Product Quality Lifecycle Implementation (PQLI®)
• 403 - Infrastructure Compliance Lifecycle
• 404 - Anticounterfeiting – Can Chemistry Trump
Bureaucracy?
• 503 - Dispelling the Part 11 Myths
• 504 - The New NIH Design Requirements Manual
for State-of-the-Art Biomedical Research Facilities
• 505 - Continuous Pharmaceutical Manufacturing
– Opportunities Now and in the Future
• 603 - Life After GAMP® 5: What Comes Next?
• 604 - Meeting Regulatory Need: The Challenge
for Generics and CMOs and the Risk of Ignoring
Warning Letters
• 605 - Validating per Annex 1
(CPIP Knowledge Element 5)
CPIP knowledge element five includes (1) production
unit operations - drug (small molecule) and biologics, (2)
production management, and (3) production control. Sessions
include:
• 102 - New Technologies in OSD
• 202 - Case Study: Cephalon Master Plan and Renovation of Corporate R & D Headquarters, Westchester, PA, USA
• 203 - Logistics: Follow the Money/Material and the Impact on Unit Pricing
• 204 - Good Engineering Practice
• 304 - Case Studies in Contained Active Pharmaceutical Ingredients (API) Pilot and Manufacturing Facilities
• 402 - Disposable Manufacturing Strategies,
Impact on Design, Operations and the Environment
• 405 - Driving Improvement for Bioprocessing Operations
• 407 - The Ever-changing Face of the Bio-Contract
Manufacturing World
• 504 - The New NIH Design Requirements Manual for
State-of-the-Art Biomedical Research Facilities
• 506 - Sustainable Projects for Existing Facilities
[Green = Profit]
• 602 - Critical Utilities – Guides, Hot Topics, and Sustainable Design
• 604 - Meeting Regulatory Need: The Challenge for Generics and CMOs and the Risk of Ignoring Warning Letters
(CPIP Knowledge Element 6)
CPIP knowledge element six includes (1) government regulations,
and (2) standards, practices, and guides. Sessions include:
ISPE 2009 Annual Meeting Tracks
Quality Systems
Investigational Products
(CPIP Knowledge Element 7)
The Investigational Products (IP) Community of Practice
(COP) brings together industry professionals for
interactive learning and networking opportunities. This
year’s sessions include educational topics that address
challenges that industry professionals face in their
day-to-day lives, as well as emerging or strategic topics
important for managers and decision-makers. For all
programming in this track, simply register for session 700.
This track’s sessions take place from Monday afternoon
through Wednesday morning. Most registrants sign up
for the full track, but also may wish to select sessions on
Sunday afternoon and Wednesday afternoon. Please see
the overall schedule for session options at those times.
General sessions and breakouts include:
CPIP knowledge element seven includes (1) risk
management and Quality Management System (QMS)
and (2) systems validation (changed from validated
controls). Sessions include:
• 104 - Risk Assessment and Risk Management
• 201 - Case Study: LEAN within Quality Assurance/
Quality Control at H. Lundbeck A/S
• 203 - Survival - From A Manufacturer’s Perspective
• 204 - Good Engineering Practice
• 205 - Regulatory Hot Topics - Town Hall Forum
• 206 - Process Analytical Technology (PAT) Used
for PQLI® and QbD: Implementation Update,
Examples, and Discussion
• 301 - Quality and Regulatory Challenges Relating
to Development, Use, and Approval of Drugs for
Medical Countermeasures
• 302 - C&Q COP Pharma Manufacturers Risk
Approach Task Team Forum
• 304 - Case Studies in Contained Active
Pharmaceutical Ingredients (API) Pilot and
Manufacturing Facilities
• 306 - Validation Master Plan Benefits, Application,
and Case Studies
• 403 - Infrastructure Compliance Lifecycle
• 404 - Anticounterfeiting – Can Chemistry Trump
Bureaucracy?
• 405 - Driving Improvement for Bioprocessing
Operations
• 503 - Dispelling the Part 11 Myths
• 504 - The New NIH Design Requirements Manual
for State-of-the-Art Biomedical Research Facilities
• 505 - Continuous Pharmaceutical Manufacturing
– Opportunities Now and in the Future
• 603 - Life After GAMP® 5: What Comes Next?
• 604 - Meeting Regulatory Need: The Challenge
for Generics and CMOs and the Risk of Ignoring
Warning Letters
• 605 - Validating per Annex 1
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• Adaptive Clinical Trials
• Optimizing the Client Vendor Relationship
• Considerations for Managing and Motivating
Clinical Supplies Personnel
• Concepts for Managing Clinical Supply Inventory
• Extemporaneous Preparation of Clinical Trial
Material (CTM) at the Investigational Site
• Supply Options for Investigator Sponsored Studies
• Panel: Key Success Factors and Strategies for Outsourcing
• Utilization of Simulation for Supply Forecasting
(Case Studies)
• Clinical Supplies in Japan
• Options for Supplying Non-Investigational Medicinal Products
• Evolution and Future Application of Simulation
• Import/Export
• Cold Chain
• Innovative Packaging and Labeling Approaches
• Wild Card session with industry thought leaders and specialists, where attendees will have the opportunity to ask questions and gain perspectives
Project Management
The PM Community of Practice (COP) has chosen two
distinct, large-scale capital projects to feature through six
highly-interactive sessions for the Project Management
Track. Attend the first of these sessions for an in-depth
presentation of each project and then explore each of the
following using the case studies as the basis for discussion
and insight.
• 108 - Case Studies
• 208 - Project Conceptualization
• 307 - Better Project Results Through Innovative
Collaboration and Outsourcing
• 308 - Project Design
• 408 - Project Construction
• 508 - Project Commissioning and Qualification
• 608 - Project Operations
Supplier-Focused
Suppliers are an incredibly important part of this program
and offer a superb knowledge resource. This year, sessions
of particular interest to suppliers are listed as a track
to recognize this important facet of ISPE educational
programming. Sessions include:
• 101 - Facility of the Year Category Award Winner Presentations
• 102 - New Technologies in OSD
• 202 - Case Study: Cephalon Master Plan and
Renovation of Corporate R&D Headquarters,
Westchester, PA, USA
• 307 - Better Project Results Through Innovative
Collaboration and Outsourcing
• 402 - Disposable Manufacturing Strategies,
Impact on Design, Operations and the Environment
• 505 - Continuous Pharmaceutical Manufacturing
– Opportunities Now and in the Future
• 604 - Meeting Regulatory Need: The Challenge
for Generics and CMOs and the Risk of Ignoring
Warning Letters
Schedule At-A-Glance
Education Sessions
SUNDAY, 8 NOVEMBER
TUESDAY, 10 NOVEMBER
WEDNESDAY, 11 NOVEMBER
13.00-17.00
08.15-11.30
08.15-11.15
101 - Facility of the Year Category Award
Winner Presentations
102 - New Technologies in OSD
103 - Combination Products:
Considerations for Entering a New Market
104 - Risk Assessment and Risk Management
301 - Quality and Regulatory Challenges Relating to
Development, Use, and Approval of Drugs for Medical
Countermeasures
302 - C&Q COP Pharma Manufacturers Risk
Approach Task Team Forum
504 - The New NIH Design Requirements Manual for
State-of-the-Art Biomedical Research Facilities
303 - Ensuring the Integrity of the Global Supply Chain
505 - Continuous Pharmaceutical Manufacturing
– Opportunities Now and in the Future
305 - Product Quality Lifecycle Implementation (PQLI )
307 - Better Project Results Through Innovative
Collaboration and Outsourcing
308 - The Real World of Project Management (Part 3 of 6):
The Project Managers Playbook – Project Design
08.30-12.00
E01 - Keynote Session
13.30-14.30
CPIPTM Introduction Workshop
13.30-17.00
201 - Case Study: LEAN within Quality Assurance/
Quality Control at H. Lundbeck A/S
08.30-09.30
CPIP Introduction Workshop
202 - Case Study: Cephalon Master Plan and Renovation of Corporate R&D Headquarters, Westchester, PA
10.30-11.30
CPIP How-to Workshop
14.00-15.00
CPIP How-to Workshop
203 - Survival - From A Manufacturer’s Perspective
14.15-17.15
401 - A Seamless Approach for Technology Transfer
700 - IP: Innovation in a Regulated Environment (Cont.)
09.00-10.00
CPIP How-to Workshop
12.45-15.45
602 - Critical Utilities – Guides, Hot Topics, and
Sustainable Design
700 - IP: Innovation in a Regulated Environment (Cont.)
204 - Good Engineering Practice
205 - Regulatory Hot Topics - Town Hall Forum
603 - Life After GAMP®5: What Comes Next?
604 - Meeting Regulatory Need: The Challenge for
Generics and CMOs and the Risk of Ignoring Warning
Letters
605 - Validating Per Annex 1
606 - 21st Century Approaches for Reducing
Manufacturing Costs During a Global Economic Crisis
402 - Disposable Manufacturing Strategies, Impact on
Design, Operations, and the Environment
206 - Process Analytical Technology (PAT) Used for
PQLI® and QbD: Implementation Update, Examples,
and Discussion
403 - Infrastructure Compliance Lifecycle
207 - Profitability through Sustainable Design [Green
= Profit]
405 - Driving Improvement for Bioprocessing Operations
208 - The Real World of Project Management (Part
2 of 6): The Project Manager’s Playbook – Project
Conceptualization
404 - Anticounterfeiting – Can Chemistry Trump
Bureaucracy?
406 - Product Quality Lifecycle Implementation (PQLI®)
608 - The Real World of Project Management (Part 6 of
6): The Project Manager’s Playbook – Project Operations
Days and Times for Special Events
The full 2009 Annual Meeting schedule will be
online at www.ISPE.org/annualmeeting.
407 - The Ever-changing Face of the Bio-Contract
Manufacturing World
700 - Investigational Products (IP): Innovation in a
Regulated Environment
408 - The Real World of Project Management (Part 4 of 6):
The Project Manager’s Playbook – Project Construction
CPIP How-to Workshop
700 - IP: Innovation in a Regulated Environment (Cont.)
ISPE Community of Practice (COP) Guide for Session Descriptions
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508 - The Real World of Project Management (Part 5 of
6): The Project Manager’s Playbook – Project
Commissioning and Qualification
306 - Validation Master Plan (VMP): Preparation,
Applications, and Case Studies
MONDAY, 9 NOVEMBER
Active Pharmaceutical Ingredients (API)
Biotechnology (Biotech)
Commissioning and Qualification (C&Q)
Containment
Critical Utilities (CU)
Disposables
Engineering Standards Benchmarking (ESB)
506 - Sustainable Projects for Existing Facilities [Green
= Profit]
®
108 - The Real World of Project Management (Part 1
of 6): The Project Manager’s Playbook – Case Studies
15.00-16.00
503 - Dispelling the Part 11 Myths
304 - Case Studies in Contained Active Pharmaceutical
Ingredients (API) Pilot and Manufacturing Facilities
106 - Logistics: Follow the Money/Material and the
Impact on Unit Pricing
502 - Sustainability for Biotech Process
Good Automated Manufacturing Practice (GAMP)
Good Control Laboratory Practices (GCLP)
Heating, Ventilation, and Air Conditioning (HVAC)
Investigational Products (IP)
Manufacturing Management (MM)
Oral Solid Dosage (OSD)
Packaging
Process Analytical Technology (PAT)
Process/Product Development (PPD)
Project Management (PM)
Sterile Products Processing (SPP)
Sustainable Facilities (SF)
www.ISPE.org/annualmeeting
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Education Sessions
(101-103)
101 - Facility of the Year Category Award
Winner Presentations
8 November 13.00-17.00
ISPE CEUs: 0.35
This session will feature presentations by each of the
Category Winners from the 2009 Facility of the Year
Awards (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
2009 Category Winning companies:
• Aseptic Technologies, winner of the Facility of the
Year Award for Equipment Innovation
• Centocor Biologics Ireland, winner of the Facility of
the Year Award for Sustainability
• Centocor R&D Schaffhausen, winner of the Facility of
the Year Award for Facility Integration
• hameln pharma, winner of the Facility of the Year
Award for Operational Excellence
• Orchid Chemicals & Pharmaceuticals, winner of the
Facility of the Year Award for Regional Excellence
• Roche Pharma Biotech Production Basel, winner of
the Facility of the Year Award for Project Execution
ISPE Communities of Practice (COPs)
All
Presenters to Date
• Clive Mullins, Vice President, Foster Wheeler,
UNITED KINGDOM (Leader)
• Benoit Verjans, Commercial Director, Aseptic
Technologies, BELGIUM
• Thornton Lewis, Project Director, Centocor
Biologics, IRELAND
• Dr. Claudio Thomasin, Centocor R&D
Schaffhausen, SWITZERLAND
• Dr. Simone Dahlmanns, Operations Director
& New Sterile Facility Project Director, hameln
pharmaceuticals, GERMANY
• Dr. K. Raghavendra Rao, Managing Director, Vice
President, Projects & Engineering, Orchid
Chemicals & Pharmaceuticals Ltd., INDIA
• Daniel Riekert, Project Director, Roche Pharma
Biotech Production Basel, SWITZERLAND
Who Should Attend
From generics, CMOs, and biotech: vice presidents and
senior vice presidents from owner companies, project
managers, architects, engineers, members of construction
companies, and vendors
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How You Will Benefit
At the end of this session, participants will be able to:
• Describe the key phases of CP development
• Understand the business, quality system, regulatory, and operational challenges of CPs
• Analyze the business perspective of entering the
CP market
Who Should Attend
102 - New Technologies in OSD
8 November 13.00-17.00
ISPE CEUs: 0.35
Quality, compliance, and regulatory professionals, as
well as product development scientists
ISPE Communities of Practice (COPs)
GCLP, IP, PPD, and PM
How You Will Benefit
At the end 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
This session will focus on:
• Product development challenges
• Impact and incorporation of product development aspects of medical device in a pharmaceutical product and pharmaceutical development in the medical device design control process
• Regulatory submission considerations for CP
• Business strategy for entering the CP market using a case study approach
• A comprehensive understanding of the topic
through a panel question and answer discussion
103 - Combination Products: Considerations for
Entering a New Market
8 November 13.00-17.00
ISPE CEUs: 0.35
What does it take for pharmaceutical, medical device, and
biologics companies to enter the market of Combination
Products (CP)? Using case studies and real-world problem
solving techniques, you can learn from the successes
and failures of those that have already undergone
this process. The overlapping elements of traditional
pharmaceutical product development stage gates, and
medical device product development prescribed by design
controls create challenges for development scientists,
quality, regulatory, and operations professionals in the
development of a CP.
Presenters to Date
• Rebecca Waterbury, Manager, Regulatory Compliance International, Abbott Vascular, BELGIUM (Leader)
• Philip Russ, Principal Consultant, Innovative
Consultants, LLC, USA
• Susan Slane, Vice President Quality, Compliance
and Analytical Chemistry, Abbott Vascular, USA
• FDA Office of Combination Products, Invited
(104-106)
104 - Risk Assessment and Risk Management
8 November 13.00-17.00
ISPE CEUs: 0.35
This session will address a systematic approach for
performing a risk assessment based on the ICH Q9
pharmaceutical lifecycle principle of a pharmaceutical
product, including product development, technology
transfer, facility design, and operations. Performing
proper risk assessment and risk management will
increase the probability of success to critical projects,
improve GMP compliance, and gain tangible return on
investment for organizations.
The presentation will include the following key items:
• Overview of ICH Q9 and ASTM E2500 Standard as
aligned to the FDA risk-based approach
• Survey of the latest risk assessment tools and
methodologies
• Pitfalls in decision making and how to avoid them
• How to make the right decision based on the
results of risk assessment
How You Will Benefit
At the end of this session, participants will be able to:
• Apply risk assessment process and tools
• Have a deeper understanding of ICH Q9 and
ASTM E2500
Who Should Attend
Project/process engineers, project managers, validation
specialists, pharmaceutical technical development
specialists, quality assurance, environment and health/
safety professionals
• Glenn Jensen, Director Engineering, BE&K, USA
106 - Logistics: Follow the Money/Material and
the Impact on Unit Pricing
8 November 13.00-17.00
ISPE CEUs: 0.35
In today’s highly competitive arena, how do companies
respond to the powerful market drivers of generic and
off-shore unit pricing? To meet these challenges, unit costs
must be reduced, but then product capacity of existing
operations must be increased necessitating upgrades and
additional production lines with limited capital investment.
How do companies concurrently maintain product integrity
and capacity flow while analyzing the existing process
prior to proceeding with the retrofit and/or procurement of
equipment?
The achievement of these goals is a complex matter and
entails careful consideration of the following:
• Every step in the production process
• How and when materials are delivered to points of use
• Identify individual constraints impacting line balance
How You Will Benefit
At the end of this session, participants will be able to:
• Evaluate business and production objectives and weigh
them against existing limitations
• Benchmark current Industry standards for logistics and
their impact on the cost of producing a product and
alternatives to reduce unit cost
• Identify line balance and all line constraints to identify
the limit of the current production and feasible cost
Who Should Attend
Biotech, C&Q, Containment, GAMP, OSD, PM, and SPP
Professionals from production/manufacturing operations,
master planning/engineering, cost control, methods,
marketing, and procurement
Presenters to Date
ISPE Communities of Practice (COPs)
ISPE Communities of Practice (COPs)
• Stephen Yu, Principle Process Engineer, BE&KDelaware, USA (Leader)
9
Presenters to Date
• Walter Motyka, Senior Director, Logistics, Strategic Operations Analysis Facility Planning, Jacobs Consultancy, USA (Leader)
• Brian Egan, AIA, LEED Director of Architecture, Jacobs
Engineering, USA
• Donald Fraser, Senior MES Consultant, Jacobs Consultancy, USA
• Paul Nicholson, VP Engineering, The Beacon Group, USA
108 - The Real World of Project Management (Part 1
of 6): The Project Manager’s Playbook – Case Studies
Sponsored by the ISPE Project Management Community of
Practice (COP)
8 November 13.00-17.00
ISPE CEUs: 0.35
The PM COP has chosen two distinct large-scale capital
projects to feature through six highly interactive sessions for
the Project Management Track.
In 2006, Genentech purchased a 75-acre property 20
miles west of Portland in Hillsboro, Oregon, USA, for the
construction and development of a new state-of-the-art
fill/finish facility. Genentech broke ground on the facility
in December 2006. The new Oregon site is expected to be
licensed and operational in 2010 and to employ approximately
300 employees by 2015. The Hillsboro site is also the location
for a new west coast warehouse and distribution center and
was operational in July 2008.
The Schering-Plough Global Clinical Supply Facility project
involved the conceptualization, design, construction,
commissioning, and qualification of a new state-of-the-art
260,000 sq. ft. clinical supply facility. The facility supports
R&D and provides drug product for world wide clinical studies.
The project was cost driven and schedule sensitive. The
complexity of the design is attributed to the changing nature
and diversity of product development, whereby the facility
design is not based on known products and defined scales,
but on drug product dosage forms and available or expected
process technology.
API, CU, Packaging, PPD, PM, and SF
www.ISPE.org/annualmeeting
9
Education Sessions
(201-202)
How You Will Benefit
At the end of this session, participants will be able to:
• Evaluate lessons-learned from two successful projects and apply to their daily work process
Who Should Attend
Project managers
ISPE Communities of Practice (COPs)
Biotech, OSD, and PM
Presenters to Date
• Keith Gibbs, Yonkers Industries, Inc., Corporate
Manager of Technical Services, Commissioning and
Qualification, USA (ISPE PM COP Steering Committee
Chair, Leader)
• Michael Cirello, Director, Clinical Manufacturing,
Schering Corporation, USA
• Jeffrey Sheppard, Project Manager, Schering-Plough, USA
• Andrew Cunningham, Principal, Flad Architects, USA
• Joseph Miller, Senior Architect, Genentech, USA
• James Gazvoda, Principal, Flad & Associates, USA
201 - Case Study: LEAN within Quality Assurance/
Quality Control at H. Lundbeck A/S
9 November 13.30-17.00
ISPE CEUs: 0.25
This session will describe a case study of the
transformation of H.Lundbeck A/S, QA/QC organization
from traditional GMP/quality group to a high performance
team within the supply operations. We will discuss how,
why, and what was done as well as the benefits of these
actions to date. After the presentation we will devote time
for a question and answer, and interactive discussion with
participants. Topics will include:
• Cultural change and technical solutions
• Results achieved and how we practice LEAN today
10 www.ISPE.org/annualmeeting
10
• Suggestions for how to get started with lean in
your QA/QC department
How You Will Benefit
At the end of this session, participants will be able to:
• Understand one way to successfully implement LEAN
in administrative and laboratory environments,
transforming into a high performance team
• Address the culture change that this type of
transformation brings about
• Involve and motivate employees in the transition
• List possible technical solutions
• Outline savings that can be realized by this change
Who Should Attend
Vice presidents, divisional directors, department heads,
and key people working with LEAN and QA/QC
ISPE Communities of Practice (COPs)
C&Q and GCLP
Presenters to Date
• Lene Andersen, Divisional Director Quality
Production, H. Lundbeck A/S, DENMARK (Leader)
• Mikael Rasmussen, Head of Department, Quality
Bulk Production, H. Lundbeck A/S, DENMARK
202 - Case Study: Cephalon Master Plan and
Renovation of Corporate R&D Headquarters,
Westchester, PA, USA
9 November 13.30-17.00
ISPE CEUs: 0.25
Learn how to create a state of the art multi-function
laboratory facility through renovation of an existing
facility, while it is in operation. In August 2009,
Cephalon will have completed a four phase renovation
of their entire R&D headquarters, a $40 million
project that touched 75% of their 160,000 sq. ft. site.
Renovation projects in a tight economic environment
are a way to control costs and address greenfield
issues. This case study will examine project drivers
and issues relating to maintaining operations while
renovating and expanding laboratory operations.
Taking three years, it was also designed to meet the
needs of the scientists, as well as to incorporate GMP
issues in the laboratory environment.
This unique case study will be a collaborative
presentation by: owner, architect, engineer, and
construction manager and will offer time for interactive
discussions. We will share lessons learned, review
costs, understand key drivers, and address cGMPs as
well as lab environment impacts.
How You Will Benefit
At the end of this session, participants will be able to:
• Describe how a renovation can be accomplished
while maintaining operation of a facility
• Delineate the advantages of renovation
• Outline the collaborative partnership among key
professionals in such a renovation
• Understand key drivers in renovation projects
Who Should Attend
Owners considering renovation, lab users, construction
managers, architects, engineers, and commissioning
and qualification personnel
ISPE Communities of Practice (COPs)
Biotech, C&Q, Containment, GCLP, HVAC, and PM
Presenters to Date
• John Holton, PE, Associate Director Engineering,
Cephalon, USA (Leader)
• Daniel Capello, Project Manager, HSC Builders &
Construction Mgrs, Inc., USA
• Anthonius Kley, Project Engineering Manager,
Cephalon, USA
• Terry A. Jacobs, AIA, Principal, Jacobs/Wyper
Architects, LLP, USA
• Michael Southwick, Pharma Division Manager, RPA
Associates, Inc., USA
(203-205)
203 - Survival - From a Manufacturer’s
Perspective
9 November 13.30-17.00
ISPE CEUs: 0.25
The pharmaceutical industry is currently going through an
industry wide transformation. Global economic conditions,
regulator oversight, and increased competition are just a
few drivers that are mandating change. This session will
ask the question “Will your plant survive?” and provide
valuable insights and strategies that can not only help
you survive but actually thrive and grow, despite the
challenges in today’s markets.
The following 10 topics will provide a strategic roadmap to
position your organization for the future by achieving best
in class status to maintain a competitive advantage.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Understanding your competition
Developing your key performance indicators
Identifying where you need to be
Measuring the efficiency of your quality
programs
Implementing Six Sigma
Starting process optimization
Implementing lean manufacturing
Utilizing risk management
Minimizing infrastructure
Managing management
Who Should Attend
Plant, general, quality, maintenance, financial and
operational managers, and manufacturing/process
engineers
ISPE Communities of Practice (COPs)
API, Biotech, OSD, SPP, and SF
Presenters to Date
• Robert Piccirillo, Director of Technology, PharmaBio Practice, Jacobs Consultancy, USA (Leader)
• Deepak Agarwal, Director, Pharma Technology, Jacobs Consultancy, USA (Leader)
11
204 - Good Engineering Practice
205 - Regulatory Hot Topics - Town Hall Forum
9 November 13.30-17.00
ISPE CEUs: 0.25
Good Engineering Practice (GEP) is defined as the
minimum set of processes and documentation that meet
end user expectations and relevant regulations covering
the construction, commissioning, operation, maintenance,
and decommissioning of an asset. This session will
provide an interactive overview of the new ISPE Good
Practice Guide: Good Engineering Practice (GEP) and
give examples of how the suggested methodologies and
templates may be used to significantly reduce the cost
and improve operation efficiency in both project and
maintenance activities.
Sponsored by the ISPE Regulatory Affairs Committee
9 November 13.30-17.00
ISPE CEUs: 0.25
This Town Hall Forum will provide participants the
opportunity to hear brief panel presentations on
relevant CMC and Quality topics by a panel of global
regulators. Participants will have the opportunity to ask
questions of the panel. Questions can be submitted to
ISPE before the conference, but question cards will be
available in the session. This is a rare opportunity to hear
discussion not only on hot topics, but discussion among
regulators representing different regions, regulations, and
approaches. There will be an update on the ICH working
group current efforts. Submit questions to Malika Hamm
at mhamm@ispe.org. Please put Regulatory Town Hall
Forum Question in the subject line of your email.
How You Will Benefit
At the end of this session, participants will be able to:
• State a clear definition of good engineering practice
• Have a common understanding of the concept
and principles of GEP
• Explain how GEP concepts may be applied in the
healthcare industry
• Balance expenditure and activity against the associated risks and benefits of a defined scope of work
At the end of this session, participants will be able to:
• Understand global regulatory topics and perspectives
• Explain current ICH initiatives
• Describe regional regulatory activities related to
CMC review and GMP inspections
Who Should Attend
Who Should Attend
Professionals in quality assurance, operations
management, and engineering management
Manufacturing industry representatives and regulatory
professionals
ISPE Communities of Practice (COPs)
API, Biotech, C&Q, Containment, CU, ESB, GAMP, GCLP,
HVAC, Packaging, PPD, PM, SPP, and SF
Presenters to Date
• Mark Foss, Head of Engineering, Boehringer
Ingelheim Ltd., UNITED KINGDOM (Leader)
• Christopher Derrett, Manager, Equipment
Technology, Schering-Plough Corp., USA
How You Will Benefit
ISPE Community of Practice (COP)
All
Presenters to Date
• Robert Baum, PhD, Executive Director, Pfizer Inc., USA
(Chair, ISPE Regulatory Affairs Committee, Leader)
• Regulators representing Europe, Japan, and the
United States will be participating
www.ISPE.org/annualmeeting
11
Education Sessions
(206-208)
206 - Process Analytical Technology (PAT) Used
for PQLI® and QbD: Implementation Update,
Examples, and Discussion
9 November 13.30-17.00
ISPE CEUs: 0.25
There is a stated need by industry for concrete PAT/
QbD examples. PQLI and PAT concepts are well defined;
however, there are still more questions than answers
on how to successfully implement and why the industry
would want to devote resources to these concepts. The
groundwork has been laid, and now the time has come
to determine how to successfully use the experience of
others. The intent is not to stand up and teach the right
answer, but to lead a discussion for discovery. This session
will address the following topics:
• Description and discussion of the four PAT tools
• Benefits and value of PAT
• Examples showing the combination of the PAT tools
in one system, with a description of realized benefits
• Question and answer session
This session content is rated advanced as attendees should
understand the definitions, current guidance, and theory
behind PAT, QbD, and PQLI.
How You Will Benefit
At the end of this session, participants will be able to:
• Understand how to communicate the concepts to
stakeholders
• Research and develop process data gathering
projects using PAT/PQLI
• Determine a path forward for utilization of process
data for process improvement
• Understand and determine the application of process
improvement tools and methods in a validated
environment
Who Should Attend
Professionals from process development, validation,
quality, manufacturing, automation, and engineering
12 www.ISPE.org/annualmeeting
12
ISPE Communities of Practice (COPs)
ISPE Communities of Practice (COPs)
Biotech, C&Q, GAMP, OSD, PAT, PPD, and PM
CU, HVAC, PM, and SF
Presenters to Date
Presenters to Date
• Nathan Temple, Project Manager, Commissioning
Agents Inc., USA (Leader)
• John Levins, PhD, Senior Director, Wyeth, USA
• Stephen Tyler, Director Strategic Quality & Technical
Operations, Abbott Laboratories, USA
207 - Profitability through Sustainable Design
[Green = Profit]
This session will feature the Facility of the Year Award
Category Winner for Sustainability: Centocor Biologics
Ireland, “BioCork”
9 November 13.30-17.00
ISPE CEUs: 0.25
This complex project was completed ahead of schedule,
under budget, and exceeded capability requirements
in all areas, most especially in sustainability. Built on a
greenfield site, the project provided traffic mitigation
alternatives, utilized advanced membrane waste water
treatment, captured rainwater for recycling, and installed
a biomass (woodchip) boiler for base steam load. BioCork
is 40% more energy-efficient than internal benchmark
biotech facilities and there was a 90% reduction in the
carbon footprint versus fossil fuel.
How You Will Benefit
At the end of this session, participants will be able to:
• Better understand the environmental sustainability
elements employed on this unique project
• Apply creative sustainable ideas to their projects
Who Should Attend
Facilities managers, plant engineers/managers, energy
managers, process engineers, architects, and design
engineers
• Paul Malinowski, Director of Project Management
and Corporate Engineering, Becton, Dickinson and Company, USA (Leader)
208 - The Real World of Project Management (Part
2 of 6): The Project Manager’s Playbook – Project
Conceptualization
Sponsored by the ISPE Project Management Community of
Practice (COP)
9 November 13.30-17.00
ISPE CEUs: 0.25
The PM COP has chosen two distinct, large-scale capital
projects to feature through six highly-interactive sessions
for the Project Management Track. See Session 108 for case
study information.
In Session 208, project team members will explore the
project management requirements at the conceptualization
phase. This interactive, discussion-focused session will
give delegates the opportunity to debate and discuss the
approach taken on two successful projects, and determine
applicability to their own projects back in the Real World. In
addition, this session will explore the handoff to design.
Concepts to be explored include: project drivers, project
delivery, project controls, and cost models.
How You Will Benefit
At the end of this session, participants will be able to:
• Evaluate lessons-learned from two successful
projects and apply to their daily work process
Who Should Attend
Project Managers
ISPE Communities of Practice (COPs)
Biotech, OSD, and PM
(301-302)
Presenters to Date
• John Honey, Associate Director, Facilities Engineering, Genentech Inc., USA (Leader)
• Keith Gibbs, Yonkers Industries, Inc., Corporate
Manager of Technical Services, Commissioning and Qualification, USA (ISPE PM COP Steering Committee Chair, Leader)
• Michael Cirello, Director, Clinical Manufacturing,
Schering Corp., USA
• Gary Schoenhouse, Director, Engineering, Genentech, USA
• Joseph Miller, Senior Architect, Genentech Inc., USA
301 - Quality and Regulatory Challenges Relating
to Development, Use, and Approval of Drugs for
Medical Countermeasures
10 November 08.15-11.30
ISPE CEUs: 0.23
The Department of Health and Human Services (HHS)
leads the research, development, acquisition, deployment,
and use of effective medical countermeasures against
terrorism and emerging diseases. The Biomedical
Advanced Research and Development Authority (BARDA)
within Office of the Assistant Secretary of Preparedness
and Response (ASPR) is the leader within HHS in the
development of vaccines and drugs to prevent or mitigate
adverse health effects caused by pandemic flu and
emerging diseases, and exposure to chemicals, biological,
nuclear, or radiation agents (CBRN).
The effort is a resource laden and time consuming process
that presents unique challenges to regulatory and quality
personnel both in industry and within the government.
• Brief history of the evolution of ASPR/BARDA
• Multi-Agency Interaction (FDA, CDC, NIH, DOD, DHS)
• Targeted Products
• Regulatory Challenges
- Aggressive drug development timelines
- Alternative labeling
- Emergency Use Authorization (EUA)
13
• Quality Challenges
- Ensuring product quality throughout the lifecycle
- Compliance expectations
- Auditing
How You Will Benefit
At the end of this session, participants will be able to:
• Understand the role of MCM
• Describe new regulatory strategies to support the labeling and use of IND products during an emergency
• Understand how strong quality systems help in early phase development to allow acceptance into the Strategic National Stockpile (SNS) and use as MCM
Who Should Attend
Professionals from regulatory affairs, quality assurance,
product development, and clinical affairs/operations
ISPE Communities of Practice (COPs)
API, Biotech, IP, Packaging, and PM
Presenters to Date
• Patricia Stewart-Flaherty, Senior Advisor, Director,
Regulatory and Quality Affairs, Department Health &
Human Services (ASPR/BARDA), USA (Leader)
• Debra Yeskey, Director, Regulatory and Quality Affairs, Department Health & Human Services (ASPR/
BARDA), USA
• Alan Liss, PhD Deputy Director Regulatory and Quality Affairs, Department Health & Human Services (ASPR/
BARDA), USA
processes based on risk and science approaches can
improve compliance, reduce the capital project timelines,
and reduce lifecycle costs. Implementation tends to
challenge current culture and established practice resulting
in varying levels of progress in transitioning from the
current state to the desired future state. Metrics to measure
progress have not been developed and owners/users cannot
gauge alignment with industry trends and best practices.
The C&Q Community of Practice (COP) chartered a user/
owner task team to compare approaches, identify best
practices, and benchmark progress against key principles
in the process of transitioning from the original ISPE
Baseline Guide: Volume 5-Commissioning and Qualification
to the new one, Science and Risk-Based Approach for
the Delivery of Facilities, Systems, and Equipment. This
session will report on progress through a presentation of
metrics and findings by this task team and will include: (1)
process overview, (2) recommend best practices, and (3)
a discussion forum with an opportunity for attendees to
challenge the panel.
How You Will Benefit
At the end of this session, participants will be able to:
• Understand the challenges to be faced in
implementing risk-based C&Q approaches
• Understand challenges and get new ideas from other pharmaceutical operating company professionals currently implementing risk-based methodologies
• Better determine the best approach(es) for your
organization
Who Should Attend
Project engineers, project managers, commissioning and
validation professionals, and quality professionals
302 - C&Q COP Pharma Manufacturers Risk
Approach Task Team Forum
Sponsored by the ISPE Commissioning and Qualification
Community of Practice (COP)
10 November 08.15-11.30
ISPE CEUs: 0.23
Streamlined commissioning and qualification (C&Q)
ISPE Communities of Practice (COPs)
API, Biotech, C&Q, CU, HVAC, OSD, PM, and SPP
www.ISPE.org/annualmeeting
13
Education Sessions
(303-305)
Presenters to Date
• Mark Rezac, Associate Engineering Director,
Merck & Co., Inc., USA (Leader)
• Steven Wisniewski, Senior Associate Director of
Compliance, IPS, USA (Leader)
303 - Ensuring the Integrity of the Global
Supply Chain
10 November 08.15-11.30
ISPE CEUs: 0.23
Ensuring the integrity of the pharmaceutical supply
chain has recently become a focus area for industry
and regulators. Over the past several years, the supply
chain has become more complex, the opportunities for
economically motivated adulteration have increased.
Consequently, the industry is facing increasing legislative
scrutiny and guidance on ensuring the quality of its
products throughout their entire lifecycle. The FDA, the
European Commission, and WHO have issued recent
guidance documents to address these challenges while
regulatory agencies around the world are in the process
of reviewing their regulations in an attempt to assure
safe, efficacious drug supply from the manufacturer to
the final delivery to the patient.
How You Will Benefit
At the end of this session, participants will be able to:
• Understand the regulations and guidance relating to supply chain management and anticounterfeiting
• Describe anticounterfeiting measures
• Develop a quality management system for assuring supply chain integrity and for ensuring public health and safety
• Design auditing programs for suppliers, distributors and shippers
Who Should Attend
Professionals from logistics and distribution, purchasing,
warehousing, manufacturing, quality assurance,
14 www.ISPE.org/annualmeeting
14
regulatory affairs, research and development, senior
experts, corporate security, regulators, suppliers, and
patient organizations (pharmacists, physicians, and
distributors)
Who Should Attend
ISPE Communities of Practice (COPs)
API, Containment, CU, Disposables, GCLP, HVAC, IP, OSD,
PAT, PPD, PM, SPP, and SF
API, Biotech, C&Q, Containment, ESB, GAMP, GCLP, IP,
OSD, Packaging, PAT, PPD, PM, SPP, and SF
Engineers, process engineers, architects, and professionals in
MEP, HVAC, operations, and API
ISPE Communities of Practice (COPs)
Presenters to Date
• Janeen Skutnik, Director, Pfizer, UNITED KINGDOM (Leader)
• Brian Rubin, Technical Consultant, BLR Engineering,
USA (Leader)
• Julian Wilkins, Vice President, PharmaConsult US Inc.,
USA (Leader)
304 - Case Studies in Contained Active
Pharmaceutical Ingredients (API) Pilot and
Manufacturing Facilities
305 and 406 - Product Quality Lifecycle
Implementation (PQLI®) Moves Forward into
Change and Knowledge Management
Presenters to Date
This is sponsored by the ISPE Active Pharmaceutical
Ingredients (API) and Containment Communities of
Practice (COPs)
10 November 08.15-11.30
ISPE CEUs: 0.23
This session will address contained API pilot and small
scale manufacturing facilities. Through case studies,
participants will learn about:
• Containment strategies
• Exposure risk from equipment (Is the closed process closed?)
• New build and retrofits
• Rigid vs. flexible
• Process innovations
How You Will Benefit
At the end of this session, participants will be able to:
• Understand the latest trends in API system design
• Describe small scale API production systems
(high value and potency) and therefore high hazard
• Explain the trend to small scale continuous process
• Discuss the issue of cost reduction and quality improvement
10 November 08.15-11.30
ISPE CEUs: 0.23
Topics that are new to PQLI will be introduced as the project
expands to understand how the ICH Quality Vision can
be implemented globally. Challenges that companies face
introducing or adapting change management and knowledge
management in a pharmaceutical quality system will be
discussed from the viewpoint of both industry and regulators
whether or not an ‘enhanced,’ quality by design approach is
used. Regulators from FDA, EU and Japan will be invited to
provide their findings reviewing applications and inspecting
companies. Leading industry speakers will be asked to
summarize their experiences. Opportunities will be given for
participants to interact with regulators and industry colleagues.
Topics to be discussed will be:
• Change management
• Knowledge management
• Risk management in the manufacturing environment
Progress of existing topics relating to QbD roadmap, quality
attributes/critical process parameters, design space, control
strategy and QbD for existing products will be illustrated with
examples of practical implementation.
(306-307)
How You Will Benefit
At the end of this session, participants will be able to:
• Contribute to the latest thinking on implementation of ICH Quality Vision and FDA’s Quality Initiative
• Describe the latest global developments
• Contribute to PQLI’s new activities
• Understand practical examples of implementation
• Better understand the perspectives of compliance
regulations
Who Should Attend
Any professional in a quality discipline.
Don’t be shy, there will something for scientists involved
in chemical process development and analysis, formulation
and packaging development and analysis, CMC project
management, technology transfer, validation, CMC
regulatory, compliance, manufacturing, quality control,
quality assurance, process control, engineering, biotech
process development and analysis. Have we missed a CMC
professional. It could be you?
components of a typical VMP are identified to integrate
with existing plant quality support systems. Case studies
provide real-life experience.
• Overview, history, benefits of, and applications for the
VMP
• Project integration – advantages of VMP development
• VMP Web resources, case studies, and question and
answer
How You Will Benefit
At the end of this session, participants will be able to:
• Know when and how to benefit from a VMP
• Locate VMP templates from provided web resources
• Customize a VMP to suit new technologies
Who Should Attend
Validation scientists, engineers, project managers, and
senior management
ISPE Communities of Practice (COPs)
C&Q, PM, and SF
Communities of Practice (COPs)
API, Biotech, GCLP, IP, Packaging, PAT, PPD, PM, and SPP
Presenters to Date
• Christopher Potter, PhD, Consultant, CMC Pharmaceutical Consultant, UNITED KINGDOM (Leader)
• Speakers from FDA, EU EMEA, and Japan will be invited
306 - Validation Master Plan Benefits, Application,
and Case Studies
10 November 08.15-11.30
ISPE CEUs: 0.23
This session will communicate background and value of
a Validation Master Plan (VMP), as well as benefits when
integrated with project management. We also help define
when and how to use VMP to support facility renovation
or introduction of new technologies. Recommended
15
Presenters to Date
• Gary Campbell, Senior Project Manager, Pharma,
M+W Zander, USA (Leader)
• Gim Crew, Senior Project Manager, Pharma, M+W Zander
307 - Better Project Results Through Innovative
Collaboration and Outsourcing
Sponsored by the ISPE Suppliers Advisory Council (SAC)
Community of Practice
10 November 08.15-11.30
ISPE CEUs: 0.23
Collaboration and outsourcing are now essential to meet
manufacturing challenges. Leaner, in-house projectoriented professionals must team up and reach out for
partners to conceive and deliver capital projects, contract
for manufacturing, and establish sustainable relationships
with alliance partners.
This session will focus on owners’ core partnering
activities and will feature innovative technology and
other supplier community resources to effectively
supplement the owners’ team to deliver projects, improve
operations and comply.
An interactive discussion among presenters and members
will focus on trends and solutions to enhance effectively
collaborations. A forthcoming Supplier Advisor Council
white paper on Procurement Practices will be presented.
How You Will Benefit
At the end of this session, participants will be able to:
• Seek and capture greater benefits from the Pharma Manufacturing Supplier Community
• Achieve greater value from leveraged relationships
• Better identify sources of manufacturing innovation and
increased network
• Attain more value from future partnerships and procurement practices
Who Should Attend
Project managers, operations managers, architects,
engineers, constructors, validators, procurement agents,
vendors, suppliers, and senior management
ISPE Communities of Practice (COPs)
API, Biotech, Disposables, OSD, PAT, PPD, PM, SPP, and SF
Presenters to Date
• Andrew Signore, PE, CPIP, CEO, IPS, USA (Leader)
• Russ Somma, PhD, President, SommaTech, LLC., USA
• Hal Baseman, COO/ Principal, ValSource LLC., USA
• Robert Chew, PE, President, Commissioning Agents, Inc., USA
• Gert Moelgaard, Vice President, Consulting, NNE
Pharmaplan, DENMARK
www.ISPE.org/annualmeeting
15
Education Sessions
(308-402)
308 - The Real World of Project Management
(Part 3 of 6): The Project Manager’s Playbook –
Project Design
Sponsored by the ISPE Project Management Community of
Practice (COP)
10 November 08.15-11.30
ISPE CEUs: 0.23
The PM COP has chosen two distinct large-scale capital
projects to feature through six highly-interactive sessions
for the Project Management Track. See Session 108 for
case study information. Project team members will explore
the project management requirements at the design
phase. This interactive, discussion-focused session will
give delegates the opportunity to debate and discuss the
approach taken on two successful projects, and determine
applicability to their own projects back in the Real World.
In addition, this session will explore the handoff from
project conceptualization and to project construction.
Concepts to be explored include:
• Collaborative design reviews
• Structured sequencing of milestones to align with construction
• Associated design bid packages
• Technology and visualization tools to aid approval
• Specification of materials based on delivery,
availability, and cost
• Flows
How You Will Benefit
At the end of this session, participants will be able to:
• Evaluate lessons-learned from two successful
projects and apply to their daily work process
Who Should Attend
Project Managers
ISPE Communities of Practice (COPs)
Biotech, OSD, and PM
Presenters to Date
ISPE Communities of Practice (COPs)
• James McGlade, Project Manager, O’Brien & Gere,
USA (Leader)
• Keith Gibbs, Yonkers Industries, Inc., Corporate Manager of Technical Services, Commissioning and Qualification, USA (ISPE PM COP Steering Committee Chair, Leader)
• Mirko Hofmann, Senior Engineering Manager,
Schering-Plough, USA
• Andrew Cunningham, Principal, Flad Architects, USA
• Joseph Miller, Senior Architect, Genentech, USA
• James Gazvoda, Principal, Flad & Associates, USA
All
401 - A Seamless Approach for Technology
Transfer
10 November 14.15-17.15
ISPE CEUs: 0.25
Technology transfer is one of the key elements of the
drug development process that requires simplicity and
efficiency. It is a must for molecule to market process
in the competitive drug development environment. This
session will first present logistics using ten principles which
are proven to assure successful scale-up, optimization,
manufacturing, packaging, and commercial launch of the
product. Next, it will elaborate on one of the ten principals,
Concurrent Database Collection (CDbC). CDbC facilitates
data sharing resulting in an accurate and rapid report of
tech transfer processes. In addition, this process could
very well fit into PAT criteria. PAT is part of the FDA’s
Pharmaceutical Quality for the 21st Century – A Risk-Based
Approach.
How You Will Benefit
At the end of this session, participants will be able to:
• Perform a seamless technology transfer process
resulting in quick and successful submissions
• Apply data sharing techniques for efficiency
Who Should Attend
Personnel from R&D, manufacturing, project management,
pilot plant, analytical, quality, and information technology
16 www.ISPE.org/annualmeeting
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Presenters to Date
• Adnan Sabir, Principal Consultant, Pharma
Consulting Services, USA (Leader)
402 - Disposable Manufacturing Strategies,
Impact on Design, Operations and the
Environment
Sponsored by the ISPE Disposables Community of
Practice (COP)
10 November 14.15-17.15
ISPE CEUs: 0.25
In the fast-evolving area of disposable technologies,
this session provides an update on the latest
developments and the state of technology as we
strive for the total disposable process. We will
address:
• As disposables become mainstream, how do they impact on manufacturing in terms of
the optimization of material flows using
lean techniques and the use of RFID for
tracking disposables throughout manufacturing?
• Ever present is concern for the environment and the latest findings on how disposables contribute
to sustainability in relation to stainless steel facilities
• Issues surrounding the retrofitting of disposables
• Practical issues surrounding implementation
• The latest information on applications
How You Will Benefit
At the end of this session, participants will be able to:
• Understand the methodology for carrying out a
carbon footprint analysis for a facility based on
stainless steel versus disposable technologies
• Evaluate the relative benefits of disposables versus stainless from an economic and lean manufacturing standpoint
(403-404)
• Understand the main differences to take into account when evaluating new facility design for disposables implementation versus retrofitting of facilities
Who Should Attend
Professionals from engineering, process development,
manufacturing, validation, and procurement
ISPE Communities of Practice (COPs)
Biotech, Disposables, PPD, and SF
Presenters to Date
• Miriam Monge, Vice President, Marketing &
Disposables Implementation, Biopharm Services
Ltd., FRANCE (ISPE Disposables COP Co-Chair, Leader)
• Adam Goldstein, Senior Manager, Clinical
Operations Purification Development, Genentech, USA
(ISPE Disposables COP Co-Chair, Leader)
• Deepak Agarwal, Director, Pharma Technology,
Jacobs Consultancy, USA
• Lindsay Leveen, Lytics Prod Management Team Lead,
Genentech, USA
• Andrew Sinclair, Managing Director, Biopharm
Services Ltd., UNITED KINGDOM
403 - Infrastructure Compliance Lifecycle
10 November 14.15-17.15
ISPE CEUs: 0.25
Infrastructure lifecycle management describes a
scalable, cost-effective approach to infrastructure
qualification. The focus is on adopting a risk-based
approach, highlighting platform qualification
which enables reuse of pre-qualified technologies.
Maintenance, operations, and retirement phases are
highlighted to complete the activities of the lifecycle
process.
How You Will Benefit
At the end of this session, participants will be able to:
• Clearly understand the paradigm shift in infrastructure
qualification
• Describe an effective approach to infrastructure
qualifications and implementation
• Execute a practical implementation of infrastructure risk assessment
Who Should Attend
Information systems and information technology engineers,
validation/qualification managers, and quality assurance
professionals
ISPE Communities of Practice (COPs)
C&Q and GAMP
How You Will Benefit
At the end of this session, participants will be able to:
• Understand how repackaging and counterfeiting
interact
• Describe which covert and forensic features are
at risk when disclosed and which are not
• Evaluate the burden of compliance against the
ease with which a determined counterfeiter can
defeat a protective method
• Evaluate packaging-based and product-based
anticounterfeiting measures by cost, complexity,
and effectiveness
• Develop a cost-effective, phased-in supply chain
integrity program
Presenters to Date
Who Should Attend
• Kofi Frimpong, Senior Manager, Methodologies,
Merial Inc., USA (Leader)
• Sion Wyn, Director, Conformity Ltd., UNITED KINGDOM
Professionals from logistics and distribution, purchasing,
warehousing, manufacturing, quality assurance,
risk management, regulatory affairs, research and
development, senior experts, corporate security,
regulators, suppliers, and patient organizations
(pharmacists, physicians, and distributors)
404 - Anticounterfeiting – Can Chemistry Trump
Bureaucracy?
10 November 14.15-17.15
ISPE CEUs: 0.25
Counterfeiting, diversion, and economically motivated
adulteration are growing threats. Increasingly skilled
counterfeiters can now defeat protective features in six to nine
months. Mass serialization offers a way to verify that a package
is genuine, but it imposes a tracking burden at each stage in
the supply chain, and one weak link can compromise legitimate
product as well. Repackaging is a challenge: it removes tamperproofing and complicates tracking. Tagging and tracking the
product itself could keep patients safe … if it can be done
simply and inexpensively with open standards. This session
explores new methods of anti-counterfeiting that blur the
traditional lines between overt, covert, and forensic methods.
These methods do not need to be kept secret in order to be
effective because criminals cannot reverse engineer them. They
use simple detectors, usable by field testers, so forensic does
not have to mean “takes weeks for the lab to provide results.”
ISPE Communities of Practice (COPs)
API, Biotech, C&Q, Containment, ESB, GAMP, GCLP, IP,
OSD, Packaging, PAT, PPD, PM, SPP, and SF
Presenters to Date
• Sharon Flank, PhD, CEO, InfraTrac, USA (Leader)
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Education Sessions
(405-407)
405 - Driving Improvement for Bioprocessing
Operations
Sponsored by the ISPE Product Process Development
(PPD) Community of Practice
10 November 14.15-17.15
ISPE CEUs: 0.25
Pharma continues to face challenges and the need for
process improvements in operations. This session will
address opportunities such as:
• Understanding the key concepts of facility design
that impact pure cultures
• Improving the operation of existing bioprocess
facilities to avoid contamination
• Managing an effective investigation of process
contamination when it does happen
How You Will Benefit
At the end of this session, participants will be able to:
• More effectively and efficiently control
bioprocessing operations
• Avoid foreign growth in bioprocess operations
• Conduct meaningful investigations
Who Should Attend
Engineers, quality control representatives, and
development chemists who are involved in operations
or process development for bioprocessing of pharma
products
ISPE Communities of Practice (COPs)
Biotech and PPD
Presenters to Date
• Cheryl Tucker, Alliance Management, Eli Lilly &
Co., USA (Leader)
• Ryan Schad, PE, Team Leader, Bioprocess
Development Pilot Plant, Eli Lilly & Co., USA
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406 and 305 - Product Quality Lifecycle
Implementation (PQLI®) Moves Forward into
Change and Knowledge Management
10 November 14.15-17.15
ISPE CEUs: 0.25
See session 305 for description.
407 - The Ever-changing Face of the Bio-Contract
Manufacturing World
10 November 14.15-17.15
ISPE CEUs: 0.25
This session explores current trends and shifts in contract
manufacturing for biopharmaceutical products. According
to the 6th Annual Report and Survey of Biopharmaceutical
Manufacturing, the current global budget climate has
created significant shifts in how biopharmaceutical
companies are outsourcing new projects. Expert panelists
will discuss how economics are playing a greater role
in the strategic outsourcing decisions. This session will
cover trends found in this global study, and the panel will
evaluate options for managing decision-making in the
current economic environment. Coverage will include:
Current industry capacity utilization and five-year trends;
Differences in expectations between U.S. vs. Western
European manufacturers; Current range of titres for MAb
production; Current capacity constraints and trends;
Expected capacity constraints by 2013; Factors creating
future capacity constraints; Key areas to address; Capacity
expansion plans; Current outsourcing, by production
system; Critical outsourcing issues; Trends in selecting a
CMO; and Difficulty in finding a CMO.
How You Will Benefit
At the end of this session, participants will be able to:
• Effectively determine the best approach to
outsourcing for their organization
• CMOs will better understand their clients explicit
concerns and problems
•Assess how current trends may affect participants’
organizations
• Describe which countries are attracting the most
outsourcing and why
• Understand current trends in outsourcing and
how to manage these shifts
• Implement an outsourcing strategy based on
current and future projected economic factors
Who Should Attend
Directors and managers of technology, downstream
purification, operations, manufacturing, and facility
design. Engineers, process development directors, and
scientists, and clinical and commercial manufacturing
staff. Staff at CMOs and Biotherapeutic developers
involved in outsourcing decisions.
ISPE Communities of Practice (COPs)
Biotech, Disposables, ESB, PPD, PM, and SPP
Presenters to Date
• Eric Langer, Managing Partner, BioPlan Associates, Inc., USA (Leader)
• Jerold Martin, Senior VP, Global Scientific Affairs,
Pall Life Sciences, USA
408 - The Real World of Project Management
(Part 4 of 6): The Project Manager’s Playbook –
Project Construction
Sponsored by the ISPE Project Management (PM)
Community of Practice (COP)
10 November 14.15-17.15
ISPE CEUs: 0.25
The PM COP has chosen two distinct large-scale capital
projects to feature through six highly-interactive sessions
for the Project Management Track. See Session 108 for
case study Information.
In 408, project team members will explore the project
management requirements at the construction phase. This
interactive, discussion-focused session will give delegates
the opportunity to debate and discuss the approach taken
on two successful projects, and determine applicability to
their own projects back in the “Real World.” In addition,
(408-503)
this session will explore the handoff from project design
to project commissioning and qualification.
Concepts to be explored include:
• Developing the least cost scope budget
• Work sequencing which allows for fast track
schedule and owner’s early integration
• Usage of BIM to minimize cost and improve schedule
• Advantages of design/build concept
How You Will Benefit
At the end of this session, participants will be able to:
• Evaluate lessons-learned from two successful
projects and apply to their daily work process
Who Should Attend
Project Managers
ISPE Communities of Practice (COPs)
Biotech, OSD, and PM
Presenters to Date
• John Postiglione, National Accounts Manager,
Spirax Sarco Inc., USA (Leader)
• Keith Gibbs, Yonkers Industries, Inc., Corporate
Manager of Technical Services, Commissioning
and Qualification, USA (ISPE PM COP Steering
Committee Chair, Leader)
• Jeffrey Sheppard, Project Manager, Schering-Plough,
USA
• Darin MacKenzie, Manager, Hoffman
Construction Company, USA
• Nathan Moroney, Project Manager, Hoffman
Construction Company of Oregon, USA
•Cliff McDonald, Project Manager, Hoffman
Construction Company of Oregon, USA
502 - Sustainability for Biotech Processes
Sponsored by the ISPE Biotech Community of Practice (COP)
11 November 08.15-11.15
ISPE CEUs: 0.25
This session will examine ways in which companies are
greening up their production processes and shop floors
to improve the environmental and energy profile of their
production processes. Traditionally the focus is usually
on facility aspects including energy efficiency related to
HVAC, lighting and recycling (green building materials are
typically discussed). Targeting these systems is impactful,
but only scratches the surface on improving the green
profile of a biomanufacturing plant. Disposables, larger
equipment requiring larger CIP/SIP, and critical utilities
increase up energy and waste stream costs. An interactive
discussion will involve attendees directly in problemsolving ideas.
How You Will Benefit
At the end of this session, participants will be able to:
• Examine new ways that pharma may green
critical utilities
• Discuss long-term and sustainable utility
conservation projects
• Recognize that increased capacity probably increases energy and waste costs and identify interventions to add conservation measures
Who Should Attend
Engineers, project managers, as well as maintenance,
operations, and environmental professionals
ISPE Communities of Practice (COPs)
Biotech, Containment, CU, Disposables, ESB, PM, and SF
Presenters to Date
• Charles Clerecuzio, PE, CPIP, VP PharmBio &
Chemicals, AMEC Power & Process Americas, USA
(Leader)
19
503 - Dispelling the Part 11 Myths
Sponsored by the ISPE GAMP Community of Practice (COP)
11 November 08.15-11.15
ISPE CEUs: 0.25
As part of its cGMPs for the 21st Century initiative, the
FDA re-examined 21 CFR Part 11 (electronic records and
signatures) as a result of concern that interpretations (by
the Agency and industry) could lead to unnecessary controls
and costs, thus discouraging innovation and technological
advances without providing added benefit to public health.
Subsequently published FDA Guidance on Part 11 Scope and
Application clearly describe the current FDA interpretation
and inspection approach, and present a pragmatic and
risk-based approach to Part 11 compliance. Myths and
misunderstandings still abound in the industry. Unnecessary
costs and impractical measures are still common, and the
benefits of innovation and technological advances are not
being fully gained.
This session aims to dispel common myths and fears, and
give companies the confidence to move forward with
practical and effective electronic record and signature
approaches. Case studies of effective and efficient Part 11
compliance will be shared. The course leader was a member
of the team that wrote the FDA Guidance on Part 11 Scope
and Application.
How You Will Benefit
At the end of this session, participants will be able to:
• Understand the real requirements for Part 11 compliance
• Avoid common pitfalls and unnecessary costs
• Achieve effective and efficient compliance for
electronic records and signatures
Who Should Attend
Computer validation practitioners, quality assurance and
quality control management, regulatory compliance and
regulatory affairs personnel, information technology and
information systems analysts, systems engineers, and
maintenance engineers
www.ISPE.org/annualmeeting
19
Education Sessions
(504-505)
ISPE Communities of Practice (COPs)
C&Q, GAMP, and PM
Presenters to Date
• Sion Wyn, Director, Conformity Ltd., UNITED
KINGDOM (Leader)
504 - The New NIH Design Requirements
Manual for State-of-the-Art Biomedical Research
Facilities
11 November 08.15-11.15
ISPE CEUs: 0.25
This session will guide attendees through the maze
of requirements, rules, and regulations that govern
biomedical and animal research facility planning,
programming, design, and construction efforts. The
presentation will introduce attendees to the New Design
Requirements Manual (DRM) and instruct on its use and
the organization of its contents. The DRM includes design
guidelines, health and safety information and biological
containment and safety requirements for the planning,
programming, and design of biomedical and animal
research facilities. Compliance with the DRM ensures that
NIH owned and funded facilities will be of the highest
quality and provides the minimum standards for other
institutions around the world.
• Planning, programming, and design of NIH
laboratory and animal research facilities
• NIH requirements for BSL/ABSL-3
• Building Automation Systems Design Consideration
• Commissioning and Decommissioning Philosophy
• Enhanced Vibration and Noise Criteria
• Caulking Checklist for Containment
• Sustainability Philosophy and Requirements
How You Will Benefit
At the end of this session, participants will be able to:
• Design and construct facilities that meet the
special needs of biomedical, animal research
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20
laboratory, and high-performance facility designers, engineers, owners, and facility managers
• Understand the requirements and the
recommendations of the DRM
• Apply up-to-date information and guidance
• Understand the minimum documentation
requirements to be presented at the completion
of the design and construction phases of a job
Who Should Attend
Individuals involved in design, construction, operation,
safety, and facility compliance of biomedical research
laboratories including: project managers/directors,
program managers/directors, project planners,
designers, contracting officers, architects and engineers
(tenured or new to industry), biological safety officers,
safety professionals, commissioning and validation
professionals, laboratory managers, construction
managers, and facility managers
ISPE Communities of Practice (COPs)
Biotech, Containment, CU, ESB, HVAC, PM, and SF
Presenters to Date
• Ricardo Herring, FAIA, Chief of Standards and
Policy Branch, Division of Technical Resources,
ORF, National Institutes of Health (NIH), USA
(Leader)
• Gabor Konkoly-Thege, Project Officer, Office of
Research Facilities, Division of Technical Resources,
NIH, USA (Leader)
• Alamelu Ramesh, PE, Chief, Technical Support
Branch, Division of Technical Resources, Office of
Research Facilities at NIH, USA (Leader)
• Antonio Ramis, PE, Senior Mechanical Engineer,
Office of Research Facilities, Division of Technical
Resources, Technical Support Branch, NIH, USA
(Leader)
505 - Continuous Pharmaceutical Manufacturing
– Opportunities Now and in the Future
11 November 08.15-11.15
ISPE CEUs: 0.25
Continuous manufacturing methodologies offer
prospects for improving the efficiency of pharmaceutical
manufacturing operations while enhancing quality
assurance. This session will discuss important scientific
and regulatory issues associated with continuous
pharmaceutical manufacturing.
Current and future opportunities for continuous
manufacturing, including the use of innovative and
advanced technologies, will be discussed by industry and
academic leaders. Regulatory issues unique to continuous
processing will also be discussed.
How You Will Benefit
At the end of this session, participants will be able to:
• Understand the value of continuous pharmaceutical
manufacturing
• Describe approaches and technologies currently
available to implement continuous manufacturing of
pharmaceutical products
• Outline future trends and opportunities in continuous
manufacturing
• Analyze the quality, validation, and regulatory issues
associated with continuous processing
Who Should Attend
Any professional in a quality discipline, scientists
and engineers involved in pharmaceutical process
development and analysis, technology transfer,
validation, CMC regulatory, compliance, manufacturing,
quality control, quality assurance, process control, and
engineering
ISPE Communities of Practice (COPs)
API, Biotech, C&Q, GAMP, IP, OSD, PAT, PPD, and PM
(506-602)
506 - Sustainable Projects for Existing Facilities
[Green = Profit]
11 November 08.15-11.15
ISPE CEUs: 0.25
How can your company thrive and continue to grow
while others fight for survival? One effective means
is to find a way to improve facility productivity by
reducing usage of raw materials, solvents utilities,
and energy. This is both environmentally sound and
good business. This session will discuss a number of
sustainability projects through case studies which
involve more efficient usage of raw materials, solvents,
steam, compressed air, and water for injection
(WFI), among other utilities. Using a six sigma type
implementation process, this session will discuss how
to maximize a project’s results and explain how to
benchmark facility consumption and improvements.
Further, utility companies and governments are
providing special rebates for projects that reduce
energy and/or water consumption. The session will
also discuss what may be available to you and what
you need to know about taking advantage of these
opportunities to significantly reduce the cost of your
sustainability project.
How You Will Benefit
At the end of this session, participants will be able to:
• Identify sustainability projects at their facility
• Use a six sigma approach to maximize and
benchmark their project
• Understand where to look to find rebates from
the government and local utilities
• Review existing processes for ways to reduce
critical and non-critical utility usage
Who Should Attend
Presenters to Date
Presenters to Date
• John Postiglione, National Accounts Manager,
Spirax Sarco Inc., USA (Leader)
• Greg Spanel, Senior Manager, Business Development, Propharma Group, USA (Leader)
• Keith Gibbs, Yonkers Industries, Inc., Corporate
Manager of Technical Services, Commissioning
and Qualification, USA (ISPE PM COP Steering
Committee Chair, Leader)
• Charles Mandala, Director, New Jersey Solid Dose
Manufacturing, Schering-Plough Corp., USA
• Christian Lamont, Manager, Engineering &
Technical Services, Schering-Plough Corp., USA
• Albert Dyrness, Vice President, Advent Engineering Services Inc., USA
• John Hughes, Manager, Operations, Total Validation Services Inc., USA
508 - The Real World of Project Management
(Part 5 of 6): The Project Manager’s Playbook –
Project Commissioning and Qualification
Sponsored by the ISPE Project Management (PM)
Community of Practice (COP)
11 November 08.15-11.15
ISPE CEUs: 0.25
The PM COP has chosen two distinct large-scale capital
projects to feature through six highly-interactive
sessions for the Project Management Track. See
Session 108 for case study information. In 508, project
team members will explore the project management
requirements at the commissioning and qualification
phase. This interactive, discussion-focused session will
give delegates the opportunity to debate and discuss
the approach taken on two successful projects, and
determine applicability to their own projects back in
the Real World. In addition, this session will explore the
handoff from project construction to project operation.
Concepts to be explored include: qualification strategy,
C&Q tracker, system test matrix, deviation handling,
and Factory Acceptance Testing (FAT) leveraging.
How You Will Benefit
At the end of this session, participants will be able to:
• Evaluate lessons-learned from two successful
projects and apply to their daily work process
Who Should Attend
Project Managers
Facilities managers, plant engineers/managers, energy
managers, and process engineers
ISPE Communities of Practice (COPs)
ISPE Communities of Practice (COPs)
Biotech, OSD, and PM
CU, HVAC, PM, and SF
21
602 - Critical Utilities – Guides, Hot Topics, and
Sustainable Design
Sponsored by the ISPE Critical Utilities Community of
Practice (COP)
11 November 12.45-15.45
ISPE CEUs: 0.25
The ISPE Critical Utilities Community of Practice (COP) is
finalizing the development of three guides scheduled for
release in 2010:
• ISPE Baseline® Guide: Volume 4 – Water and
Steam Systems (Revision)
• ISPE Good Practice Guide: Ozone Sanitization of
Pharmaceutical Water Systems
• ISPE Good Practice Guide: Process Gases
The leaders of all three guides will present an overview
on the content of each and discuss the potential impact
of these publications. Additional chapter leaders and
contributors will discuss hot topics associated with
critical utilities. The impact on sustainable design issues
incorporated into each Guide will also be discussed.
www.ISPE.org/annualmeeting
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Education Sessions
(603-606)
How You Will Benefit
At the end of this session, participants will be able to:
• Understand current trends, hot topics, and impact on sustainable design on critical utility systems
Who Should Attend
• Identify some common problems faced by
industry in the implementation of GAMP 5
• Explore possible solutions to challenges
Who Should Attend
Process engineers, design and equipment engineers,
facilities and maintenance personnel, and QA/QC
professionals
Computer validation practitioners, quality assurance and
quality control management, regulatory compliance and
regulatory affairs personnel, information technology and
information systems analysts, systems engineers, and
maintenance engineers
ISPE Community of Practice (COP)
ISPE Communities of Practice (COPs)
CU
Presenters to Date
• Andrew Collentro, Technical Director, Water
Consulting Specialists, Inc., USA (Leader)
• Cameron Sipe, Kinetics, USA
• Philip Sumner, PE, Manager, Global Engineering, Pfizer, USA
• Chad Larrabee, Category Manager, Ingersoll-Rand,
USA
603 - Life After GAMP® 5: What Comes Next?
Sponsored by the ISPE GAMP Community of Practice (COP)
11 November 12.45-15.45
ISPE CEUs: 0.25
GAMP 5 was published in 2008 to great acclaim around
the world. Just having the guide published does not mean
the benefits it offers will automatically be achieved. This
seminar will look at some of the corporate and culture
challenges to effective implementation. The seminar will
include workshop elements to explore challenges and how
they might be resolved.
How You Will Benefit
At the end of this session, participants will be able to:
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This session will address the real world implementation
of these requirements. What changes from past practices
are required for on-going and periodic revalidation
of facilities? Case studies from pharma company
implementations of the revised guidance for requirements
during capping will be discussed.
How You Will Benefit
C&Q, GAMP, and PM
At the conclusion of this session, participants will be able
to:
• Apply knowledge of the changing regulatory
environment to validation of sterile pharmaceutical
operations in the EU
Presenters to Date
Who Should Attend
• Paige Kane, Director Knowledge Management &
COP, Wyeth Pharmaceuticals, USA (Leader)
• Guy Wingate, PhD, Quality Director,
GlaxoSmithKline, UNITED KINGDOM (Leader)
Professionals who are responsible for designing, reviewing,
testing, operating, qualifying or validating equipment and
systems for sterile pharmaceutical manufacturing
ISPE Communities of Practice (COPs)
604 - Meeting Regulatory Need: The Challenge
for Generics and CMOs and the Risk of Ignoring
Warning Letters
C&Q, Containment, HVAC, and SPP
Presenters to Date
11 November 12.45-15.45
ISPE CEUs: 0.25
• Vincent Cebular, Vice President Compliance Ops., IPS, USA
605 - Validating Per Annex 1
606 - 21st Century Approaches for Reducing
Manufacturing Costs During a Global Economic
Crisis
Sponsored by the ISPE SPP Community of Practice (COP)
11 November 12.45-15.45
ISPE CEUs: 0.25
Annex 1 to the EU GMP Guidelines, covering sterile
medicinal products, was revised and updated in 2008. The
revisions updated four main areas:
• Classification of environmental cleanliness of clean
rooms, and associated text
• Guidance on media simulations
• Guidance on bio-burden monitoring
• Guidance on capping of freeze-dried vials
11 November 12.45-15.45
ISPE CEUs: 0.25
Times of economic crisis present opportunities to
streamline operations and implement cost saving
technologies. A recent Georgetown University report
confirms that there are billions of dollars to be recouped
by modernizing pharmaceutical manufacturing operations
and reducing non-value-added practices. Principles of lean
manufacturing, operational excellence, and innovative
manufacturing technologies can improve manufacturing
(608-700)
efficiency and lower the cost of production. While other
sessions at Annual Meeting will look at some of these
issues in detail, this session will overview a number of
opportunities to consider.
In this session we will specifically focus on:
• Reducing capital investment through disposables
• Learning from lean contract manufacturers –
how do they do things more economically?
• Continuous processing to reduce foot print, equipment costs while debottlenecking downstream operations
• How recent risk-based regulatory guidance (E 2500, ICH Q9) can streamline the qualification process and lower start-up costs
Who Should Attend
Professionals from manufacturing operations,
engineering, quality assurance, and finance
to their own projects back in the “Real World.” In
addition, this session will explore the handoff from
Project Commissioning and Qualification and explore
the end-game of a successful project and inheritance
of that project by the site or corporate entity. Concepts
to be explored include: operational efficiency, lean
design, and how it impacts operations, staffing
strategies, and BioG (OE).
How You Will Benefit
At the end of this session, participants will be able to:
• Evaluate lessons-learned from two successful
projects and apply to their daily work process
Who Should Attend
Project Managers
ISPE Communities of Practice (COPs)
Presenters to Date
Biotech, OSD, and PM
• Peter Watler, PhD, Principal Consultant and
CTO, Hyde Engineering + Consulting Inc., USA
(Leader)
Presenters to Date
608 - The Real World of Project Management
(Part 6 of 6): The Project Manager’s Playbook –
Project Operations
Sponsored by the ISPE Project Management (PM)
Community of Practice (COP)
11 November 12.45-15.45
ISPE CEUs: 0.25
The PM COP has chosen two distinct large-scale capital
projects to feature through six highly interactive sessions
for the Project Management Track. See Session 108 for
Case Study Information. In 608, project team members
will explore the Project Management Requirements at
the Turn-over and Operations phase. This interactive,
discussion-focused session will give delegates the
opportunity to debate and discuss the approach taken
on two successful projects, and determine applicability
23
• Dave Koncak, Director of Engineering, Pfizer Inc.,
USA (Leader)
• Keith Gibbs, Yonkers Industries, Inc., Corporate
Manager of Technical Services, Commissioning
and Qualification, USA (ISPE PM COP Steering
Committee Chair, Leader)
• Michael Cirello, Director, Clinical Manufacturing,
Schering Corp., USA
• Daniel Jordan, Fill/Finish Operations Director,
Genentech Hillsboro, USA
700 - Investigational Products – Innovation in a
Regulated Environment
Sponsored by the ISPE Investigational Products (IP)
Community of Practice (COP)
9 November 13.30-17.00
10 November 08.15-11.30 and 14.15-17.15
11 November 08.15-11.15
ISPE CEUs: 11.5; ACPE Credits Pending
The IP COP brings together industry professionals for
interactive learning and networking opportunities. This
year’s Investigational Products Sessions will include
educational topics which address challenges that
industry professionals face in their day-to-day lives,
as well as emerging or strategic topics important for
managers and decision makers. The meeting kicks
off with themed, focused and interactive, concurrent
workshops. Participants will have the opportunity to
provide their own perspectives on the topic and take
away actionable solutions. The workshop choices are:
• Utilization of Simulation for Supply Forecasting
(Case Studies) –or– Clinical Supplies in Japan
• Options for Supplying Non-Investigational Medicinal Products –or– Evolution and Future Application of Simulation
General sessions then bring everyone together
and are anchored by a keynote presentation on
Emerging Markets for Clinical Trials. Broad-based
podium presentations follow (watch www.ISPE.
org/annualmeeting for updates on these topics and
speakers). Another set of concurrent, podium sessions
allow attendees to select the topics of most importance
to their interest. These include:
• Optimizing the Client Vendor Relationship –or–
Considerations for Managing and Motivating
Clinical Supplies Personnel
• Concepts for Managing Clinical Supply Inventory
–or– Extemporaneous Preparation of Clinical
Trial Material (CTM) at the Investigational Site
• Supply Options for Investigator Sponsored Studies –or– Panel: Key Success Factors and Strategies for Outsourcing
www.ISPE.org/annualmeeting
23
Education Sessions
(700 Cont.)
Later in the day, four topics (to be repeated once)
provide the opportunity for attendees to attend any
two of the four topics:
• Import/Export
• Cold Chain
• Innovative Packaging and Labeling Approaches
• Wild Card session with industry leaders and specialists – attendees will have the opportunity to ask questions and gain a cross-section of perspective
A final general session includes a topic on Adaptive
Clinical Trials and a presentation on the ISPE IP
Community of Practice and “What’s in it for you?” The
IP Track at ISPE Annual Meeting brings a wealth of
keynote, general, concurrent, and workshop sessions
to meet your learning and networking needs.
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
• Examine the value of tools/solutions for forecasting and managing clinical supplies
• Relate to challenges and duty implications faced in importing clinical supplies and employ solutions/
suggestions to mitigate these challenges
• Optimize the client-vendor relationship
• Advance supply chain capabilities and performance
• Discuss real challenges and solutions in the IP community
• Expand your professional network
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
24
24 www.ISPE.org/annualmeeting
Leaders to Date
• David Riege, Associate Research Fellow, Supply Chain Mgmt, Pfizer, Inc., USA (ISPE Annual Meeting Task Team Leader)
• Kunal Jaiswal, Director, Global Clinical Supply,
Schering-Plough Corporation, USA
• Steven Yoder, Manager, Clinical Trial Materials
Management, Eli Lilly & Company, USA
• Neal Gordon, PhD, Senior Director, Schering-Plough Research Institute, USA
• Mike Arnold, RPh, Business Process Head, GSC,
Pfizer Inc., USA (North America IP COP Chair)
Certified Pharmaceutical Industry ProfessionalTM
(CPIPTM) Certification Program Workshops
Introduction Workshops
9 November 13.30-14.30
10 November 08.30-09.30
These complimentary, one hour workshops provide an
overview of the CPIP, a pharmaceutical industry focused,
international competency-based credential made available
through the ISPE Professional Certification Commission.
Topics include: CPIP introduction, eligibility criteria, and the
application and examination processes explained.
How-to Workshops
9 November 15.00-16.00
10 November 10.30-11.30
10 November 14.00-15.00
11 November 09.00-10.00
These complimentary, one hour workshops provide guidance
on how to submit a CPIP eligibility application and prepare for
the CPIP examination. Topics include: obtaining a university
transcript, completing the professional experience forms, using
the CPIP Study Guide resources CD and organizing CPIP study
groups.
Learn more about this certification program at
www.ISPE-PCC.org.
Call for Poster Presentations
Due 30 June 2009
What is a Poster Presentation?
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, More Information
www.ISPE.org/annualmeeting
ISPE Networking Events
To lessen our impact on the environment, the ISPE 2009
Networking Brochure is now available only at www.
ISPE.org/annualmeeting as a PDF for easy download.
Easy Steps to Register for Networking Events
Option 1: Online Registration - Get registered for all
ISPE 2009 Annual Meeting Networking Events and the
Guest Package online at www.ISPE.org/annualmeeting,
or Option 2: Fax, Email, or Mail - Download the ISPE
2009 Annual Meeting Networking Events Registration
Form at www.ISPE.org/annualmeeting and completely
fill it out, 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
We invite all registered 2009 Annual Meeting delegates
to join us in the Exhibit Hall for a welcome gathering.
Meet new colleagues and catch up with old friends
while enjoying refreshments and hors d’oeuvres. More
than 250 suppliers will be on hand to answer questions
and give you a sneak peak at what’s new in the
industry.
ISPE 2009 Communities of
Practice Night
Monday, 9 November
COP General Reception
17.30-19.00
Price: US$20 (not included with any package fees)
Join us at ISPE’s second annual COP Night to network
with friends and colleagues sharing similar interests in
a fun-filled relaxing atmosphere. ISPE’s 18 Communities
of Practice (COPs) are teaming up to offer attendees an
experience customized to their interests. Participating
COPs include:
Active Pharmaceutical Ingredients, Biotechnology,
Commissioning and Qualification, Containment,
Critical Utilities, Disposables, Engineering Standards
Benchmarking, GAMP®, Good Control Laboratory
Practices, Heating, Ventilation, and Air Conditioning,
Investigational Products, Oral Solid Dosage, Packaging,
Process Analytical Technology, Process/Product
Development, Project Management, Sterile Products
Processing, and Sustainable Facilities
Registration for the COP General Reception is required.
The registration form can be found at www.ISPE.org/
annualmeeting in the networking section.
COP Reception Sponsorship Opportunities
ISPE’s COP Night Reception provides exclusive, costeffective, and targeted sponsorship opportunities.
Contact Dave Hall at dhall@ispe.org or Valerie Adams at
vadams@ispe.org for specific details.
COP Dinners
19.30-21.30
Price: US$70 (not included with any package fees)
At the conclusion of the COP General Reception, several
COPs will offer Annual Meeting attendees a customized
social dinner event. The evening promises to offer a
genuine, laid back Southern California experience at
exciting restaurants in the heart of San Diego’s historic
Gaslamp District. Look for a list of participating COPs
online when registering.
Registration for the COP Dinners is required. The
registration form can be found at www.ISPE.org/
annualmeeting in the networking section.
Tuesday Night Party
Tuesday, 10 November
19.00-22.00
Price included in Full Education Delegate Fee and
Guest Package. A la carte: US$200 (includes dinner and
entertainment)
Come ready to network, relax, and have fun! This event
will offer a variety of entertainment opportunities. Find
details in the Networking Brochure at www.ispe.org/
annualmeeting.
Guest Package
A guest package is available to all guests of ISPE 2009
Annual Meeting attendees. The package includes
admission to the Sunday Night Welcome Reception, a
brunch cruise on the San Diego Bay on Monday, the
choice of seaside shopping in La Jolla or strolling in
Coronado on Tuesday, and admission to the Tuesday
Night Party. All activities are available a la carte as well.
(Minimum number of attendees required for Monday
and Tuesday activities. Register early or activities may be
cancelled 30 days prior to the event.)
Wednesday Optional Events
• ISPE Golf Tournament at Steele Canyon
• Trip to the San Diego Zoo
• Tour Aircraft Carrier USS Midway and City Tour
See the full Networking Events Brochure at www.ISPE.org/
annualmeeting/networking.
There are many things to do in San Diego. Call or visit the
hotel concierge at the Manchester Grand Hyatt for details.
www.ISPE.org/annualmeeting
25
Event Highlights
Keynote Session
Monday, 9 November
08.30-12.00
The Keynote Session is just one of the many
opportunities at ISPE 2009 Annual Meeting for
pharmaceutical manufacturing science and
biotechnology professionals to learn about emerging
global industry trends and practices.
Speakers to be announced.
Membership Luncheon and Awards
Ceremony
Tuesday, 10 November
11.45-13.45
Join ISPE leadership and colleagues in celebration of
outstanding achievements. Special recognition awards
will be presented to Members, Affiliates, Chapters,
committees, companies, authors, and students.
ISPE leaders provide their insight on Society
accomplishments in 2009 and offer 2010 goals.
5K Run
Sunday, 8 November
Early Morning
ISPE is organizing a 5K run for Annual Meeting
participants. Watch for details at www.ISPE.org/
annualmeeting.
New Member First Time Attendee
Orientation Breakfast
Monday, 9 November
07.00-08.30
During this informal, high energy breakfast, new
Members and first time attendees will have an
opportunity to learn about the Society, how to navigate
the Annual Meeting, and network with other attendees.
Don’t forget to bring plenty of business cards for the
special networking activities! Event hosted by ISPE’s
26 www.ISPE.org/annualmeeting
26
Membership Development Committee. Please be sure
to sign up for this event on the 2009 Annual Meeting
Delegate Registration Form.
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 ISPE related questions.
Career Café
Students Connect with Industry Professionals
and Fellow Students at Annual Meeting
For job seekers, the ISPE 2009 Annual Meeting Career
Café features job postings, the chance to post résumés
online, and the opportunity to meet with prospective
employers who are exhibiting at the event.
By posting a job at the Career Café, employers gain
exposure to a highly-targeted and experienced audience
– all 2009 Annual Meeting delegates, students, speakers,
committee volunteers, and exhibitors. Positions will be
posted on job boards and private interview space will
be available to Featured Employers. To view employer
packages, please visit www.ISPE.org/careers or contact
Dave Hall at dhall@ispe.org.
Cyber Café
Access the Internet at the ISPE Cyber Café located in the
Exhibit Hall - open during exhibit hours (see page 27).
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 to ISPE, we
invite you to join us in ISPE’s Volunteer Lounge, available
exclusively to ISPE Volunteers.
Downloads
Visit the Downloads Page at www.ISPE.org/
annualmeeting to view registration forms, the delegate
roster (available 20 October), presentation handouts, and
exhibitor forms.
ISPE Knowledge Center
Open Sunday Afternoon to Wednesday
New this year, 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 2009 Annual Meeting offers many opportunities for
you to meet and greet industry professionals and other
students, learn about industry trends, and make valuable
connections to boost your career potential. If you are an
ISPE Student Member, or are interested in becoming a
Student Member and would like to attend, contact ISPE
Member Services by tel: +1-813-960-2105, or email ask@
ispe.org.
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 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 ISPE 2009 Annual Meeting
Membership Luncheon and Awards Ceremony on Tuesday,
10 November.
Winners receive a monetary prize and recognition in
ISPE publications. Participants have the opportunity to
publish an article based on their poster presentation
in ISPE’s Pharmaceutical Engineering magazine or the
Journal of Pharmaceutical Innovation. Visit www.ISPE.org/
campusconnection for details.
Student Activity Schedule
Sunday, 8 November
12.30-15.00
Student Lunch/Orientation with Industry Speakers
• Developing Job Interviewing Skills
15.00-16.00
Student Poster Set Up
Event Highlights
Monday, 9 November
13.30-17.00
Student Poster Competition
Tuesday, 10 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
Affiliate/Chapter Council Activities
Monday, 9 November
13.30-17.00
Joint Affiliate Councils’ Meeting - North and South
America/Europe/Asia Pacific
Tuesday, 10 November
11.45-13.45
Membership Luncheon and Awards Ceremony
08.30-11.30
North America South America Affiliate Council Meeting
08.30-11.30
Asia Pacific Affiliate Council Meeting
14.00-17.00
Affiliate/Chapter/Student Chapter* Workshops for
North and South America/Europe/Asia Pacific
*Student Chapter Workshops are for Faculty and Industry
Advisors and Affiliate/Chapter/Student Affairs Chairs;
optional for Students
27
Showcase Your Products and Services at
the Table Top Exhibition
The ISPE Annual Meeting Table Top Exhibition is your
prime opportunity to gain access to and interact
with key decision makers and buyers from the global
pharmaceutical and biotech manufacturing industry.
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$2,750 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 Dave Hall at dhall@
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 badges.
Exhibit Hall Hours
Manchester Grand Hyatt
About San Diego
With its great weather, miles of sandy beaches, and
major attractions, San Diego is known worldwide as one
of the best tourist destinations. Its charming, historic
neighborhoods such as the Gaslamp Quarter, Little Italy,
Coronodo, La Jolla, and Del Mar, are sought out by locals
and tourists alike. Popular attractions include the worldfamous San Diego Zoo and Wild Animal Park, Sea World
San Diego, and Legoland California. San Diego offers an
expansive variety of things to see and do, appealing to
guests of all ages from around the world.
Sunday, 8 November 17.00-18.30
Monday, 9 November 07.00-16.15
Tuesday, 10 November 07.00-11.00
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.
www.ISPE.org/annualmeeting
27
General Information
How to Register
Education delegates, committee members, speakers,
government and university faculty, and ISPE Student Members
may register:
• Online: Visit www.ISPE.org/annualmeeting
• Via Fax: Complete the registration form in this brochure and fax it to: +1-813-264-2816
• Via Mail: Complete the registration form in this brochure and mail it 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.
This year’s Annual Meeting Networking Events Brochure is only
available in electronic format. Download the Brochure at www.
ISPE.org/annualmeeting to register for the Guest Package and
to sign up for Optional Events.
Hotel Accommodations, Information and Reservations
Headquarters Hotel
The Manchester Grand Hyatt is the headquarters hotel for the
ISPE 2009 Annual Meeting.
Manchester Grand Hyatt
One Market Place
San Diego, California, 92101 USA
Tel: +1-619-232-1234, Fax: +1-619-233-6464
www.manchestergrand.hyatt.com
Reservations must be made through ISPE.
Hotel Accommodations and Reservations
The Manchester Grand Hyatt offers ISPE meeting attendees
a discounted hotel rate of US$276.96 (including taxes).
This rate is good until 5 October 2009 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 30 for more information.
Cancellation fees apply.
Please be advised that ISPE has only one contracted hotel
for the ISPE 2009 Annual Meeting. We urge you to make all
room reservations for the ISPE 2009 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 Manchester Grand Hyatt.
Hotel Parking
Self parking is available for US$22 overnight and valet
parking is available for US$32 overnight. Prices are subject
to change.
Airport Transportation
The closest airport to the Manchester Grand Hyatt is
San Diego International Airport (SAN) (7 minutes, 3
miles/4.83 kilometers). Taxi service is approximately
US$10–$13. Express Shuttle is available with reservations
for approximately US$8. Call tel: 1-800-900-7433 or tel:
+1-619-591-0303.
Dress is Business Casual
All ISPE Annual Meeting delegate functions are business
casual. The guest, optional, and evening functions are
casual. Typical autumn weather in San Diego calls for high
temperatures around 70°F/21°C and lows around 54°F/12°C.
Temperatures in meeting rooms tend to be cool so bring a
light jacket or sweater.
Substitutions
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 13 September 2009 will result in a US$800
fee. Exhibitors are responsible for the full Table Top fees for
cancellations made in writing after 13 September 2009.
Education Program, Guest Package, and Exhibit Badge
Cancellations
Education program, guest, and exhibit badge cancellations will
be accepted only in writing. If received by 19 October 2009, 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, in rare circumstances, 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.
ACPE CEUs
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/annualmeeting
for updates.
ISPE CEUs and Accreditation
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
field or profession. 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/annualmeeting 28
ISPE 2009 Annual Meeting Education Delegate Registration Form
W
ONLINE: www.ISPE.org/annualmeeting
FAX: +1-813-264-2816
MAIL: ISPE, 3109 W. Dr. Martin Luther King Jr. Blvd., Suite 250, Tampa, Florida, 33607 USA
Attach Hotel Reservation Request 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 # _______________________________________________
Early Bird
12 Oct.
First Name _______________________________________MI___________Last Name________________________________ Emergency Phone: Cell Phone _______________________________ or Home Phone________________________________
Informal Badge Name ______________________________Chapter/Affiliate_________________________________________ FULL EDUCATION
FEES
Job Title______________________________________________ Email Address______________________________________ No refunds after
On or Before
12 October
After 12 October
TOTAL
US$
Company________________________________________________________________________________________________
$1,375
$1,675
$
Business Address___________________________________________________City____________________________________ New Member
$1,590
$1,890
$
Business Tel______________________________________________Business Fax____________________________________
Nonmember
$1,670
$1,985
$
Committee
$ 750
$ 750
$
19 October
Current Member
(Fee includes oneState/Province________________________ Zip+4/Postcode______________________Country ___________________________ year ISPE Membership, a $215 value)
__
PLEASE SELECT SEMINARS OF CHOICE
306 - Validation Master Plan
CPIPTM Certification Program Introduction Workshops
(Complimentary)
Mon 13.30-14.30 Tues 08.30-09.30
CPIPTM Certification Program How-to Workshops
(Complimentary)
Mon 15.00-16.00 Tues 10.30-11.30 Tues 14.00-15.00
Weds 09.00-10.00
307 - Better Project Results - Collaboration and Outsourcing
Government
$ 840
$ 840
$
308 - Project Management: Project Design
Academia Member
$ 690
$ 840
$
700 - Investigational Products (Part 2 of 4)
Student Member
$ 475
$ 475
$
Sunday, 13.00-17.00
101 - Facility of the Year
102 - New Technologies OSD
103 - Combination Products
104 - Risk Assessment and Risk Management
106 - Follow the Money
108 - Project Management: Case Studies
Keynote Session - Mon 08.30-12.00
Monday, 13.30-17.00
201 - Case Study: LEAN Quality Assurance
202 - Cephalon Master Plan
203 - Survival - Manufacturer’s Perspective
204 - Good Engineering Practice
205 - Regulatory Town Hall Forum
206 - PAT for PQLI® and QbD
207 - Profitability Through Sustainable Design
208 - Project Management: Project Conceptualization
700 - Investigational Products (Part 1 of 4)
Tuesday, 08.15-11.30
301 - Challenges to Drugs for Countermeasures
302 - C&Q Forum
303 - Supply Chain
304 - Case Studies API Pilot Facilities
305 - PQLI
®
Tuesday, 14.15-17.15
401 - Technology Transfer
402 - Disposables
403 - Infrastructure Compliance
404 - Anticounterfeiting
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 attend the New
I will not attend any meals, receptions, or parties
Member/First-time ISPE
Monday Lunch
Annual Meeting Attendee
Tuesday Membership Lunch and Awards Ceremony
Orientation Breakfast
Tuesday Party
on Monday. Details page 26.
Wednesday Lunch
Kosher
Vegetarian Gluten Free
Special Meal Requirement
405 - Improving Bioprocessing Operations
406 - PQLI
®
407 - Changing Face Bio-Contract Manufacturing
408 - Project Management: Project Construction
700 - Investigational Products (Part 3 of 4)
Wednesday, 08.15-11.15
502 - Sustainability for Biotech
503 - Part 11 Myths
504 - NIH Design Manual Biomedical Facilities
505 - Continuous Pharma Manufacturing
506 - Sustainable Projects Existing Facilities
508 - Project Management: C&Q
700 - Investigational Products (Part 4 of 4)
Wednesday, 12.45-15.45
602 - Critical Utilities
603 - Life After GAMP®5
604 - Risk of Ignoring Warning Letters
605 - Validating Per Annex 1
606 - 21st Century Approaches Manufacturing Costs
608 - Project Management: Operations
I do not wish my information to be printed in the
Membership Directory.
I’m a new ISPE Member.
I’m a first-time ISPE Annual Meeting attendee.
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
SINGLE DAY
FEES*
On or Before
12 October
After 12 October
Half Day
Sunday
$ 250
Member
Nonmember $ 290
Member
$ 300
Nonmember $ 340
$
One Day
Monday
Tuesday
Wednesday
Member
$ 475
Nonmember $ 560
Member
$ 575
Nonmember $ 660
$
1 1/2 Day
Sunday/Monday
Member
$ 725
Nonmember $ 850
Member
$ 875
Nonmember $1,000
$
Two Day
Monday/Tuesday
Tuesday/Weds
$ 950
Member
Nonmember $1,120
Member
$1,150
Nonmember $1,320
$
___________________________________________
2 1/2 Day
Sun/Mon/Tues
$1,200
Member
Nonmember $1,410
Member
$1,450
Nonmember $1,660
$
Cancellations must be made in writing.
No registration refunds after
19 October 2009.
Sun. to Weds., check
days you will attend.
TOTAL
US$
I wish to keep my data confidential and it is given only
for use by ISPE and its local Chapters and Affiliates.
Expiration Date
___________________________________________
Name of Cardholder (as it appears on card)
___________________________________________
Cardholder Signature
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 attend the New
I will not attend any meals, receptions, or parties
Member/First-time ISPE
Monday Lunch
AM
Attendee Orientation
Tuesday Membership Lunch and Awards Ceremony
Breakfast. Details page 26.
Wednesday Lunch
Special Meal Requirement
Kosher
Vegetarian Gluten Free
Tues Party
___________________________________________
$200
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
$
TOTAL US$ $
29
ISPE 2009 Annual Meeting Hotel Reservation Request Form
Hotel accommodations will book fast! Early registration is strongly recommended.
Official Hotel Headquarters for
ISPE 2009 Annual Meeting
Manchester Grand Hyatt
The Manchester Grand Hyatt offers ISPE meeting attendees a
discounted hotel rate of US$276.96 (including taxes). This
rate is good until 5 October 2009 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/annualmeeting. 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 ($276.96 US Dollars drawn
on a US bank and payable to Manchester Grand Hyatt).
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 12 October 2009. A confirmation
email will be sent by the hotel after 12 October 2009.
A deposit of one night (US$276.96) is required to hold your
room reservation and is nonrefundable after 12 October 2009.
Credit cards will be charged one night as of 12 October. Please
complete the credit card information in full.
ISPE has only one contracted hotel for the ISPE 2009 Annual
Meeting. We urge you to make all room reservations for the
ISPE 2009 Annual Meeting at www.ISPE.org/annualmeeting,
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.
30 www.ISPE.org/annualmeeting
30
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
W
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, 8 November to Wednesday, 11 November
Name (print)________________________________________________________ISPE ID #___________________________________
Email Address_____________________________________________________ Company____________________________________
Please reserve one (1) room for _____________ people for Arrival on __________________ Departure on _____________________
Room Type Preferred:
Handicapped
Non-Smoking
Smoking
King Bed
Double Beds
Estimated Time of Arrival _______________________________________
Please notify us in writing if you have any special requirements.
Address___________________________________________________________________________________
City ______________________________ State/Province___________________ Zip+4/Postcode _______________Country _________
Tel ______________________________________________________________ Fax ______________________________________
Name(s) of person(s) sharing accommodations________________________________________________________________________
Credit Card Type________________________________ Credit Card Number______________________________________________
Expiration Date______________________________________________________________________________________________
I authorize the Manchester Grand Hyatt to charge my account for one night’s deposit plus applicable taxes as of 12 October.
Signature__________________________________________________________________________________
Manchester Grand Hyatt 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 Manchester Grand Hyatt
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 Manchester Grand Hyatt 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.
Special Thanks to Our Sponsors
Platinum Sponsors
Annual Meeting Sponsorships:
Create Brand Awareness, Increase Visibility,
and Develop New Business
Becoming an Annual Meeting sponsor guarantees
your company wide exposure to key decision makers
in pharmaceutical and biotech manufacturing with
a minimum investment of your time and personnel.
We offer a range of new 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. We also offer onsite advertising
opportunities.
Gold Sponsors
The Communities of Practice Night on Monday, 9
November also offers unparalleled exposure to a
targeted audience providing cost-effective sponsorship.
Contact Dave Hall at dhall@ispe.org or Valerie Adams
at vadams@ispe.org to secure your sponsorship(s).
Silver Sponsors
COP Night Sponsor
31
Hotel Key Cards Sponsor
Exhibit Hall Giveaway Passport Sponsors
www.ISPE.org/annualmeeting
31
NON-PROFIT ORG.
U.S. POSTAGE
engineering pharmaceutical innovation
3109 W. Dr. Martin Luther King Jr. Blvd.,
Suite 250 | Tampa, FL 33607
PAID
TAMPA, FL
PERMIT NO. 2661
ISPE
Annual Meeting
Thriving In A Survival Environment
8 • 11 N o v e m b e r
Manchester Grand Hyatt San Diego
San Diego, California, USA
www.ISPE.org/annualmeeting
www.ISPE.org/annualmeeting