22-25 February • Grand Hyatt Tampa Bay • Tampa, Florida, USA
www.ISPE.org/2010tampaconference
Sponsorship and Table Top Exhibit Opportunities Available
ISPE
Tampa
Conference
Applying Solutions to Emerging
Industry Challenges
Seminars
• Aseptic Processing of Sterile Products:
Innovations, Regulatory Guidance and
Compliance in a Practical World
• Inspection Readiness Workshop: From Site
Preparation to Successful Execution
• Oral Solid Dosage: New Guidance
You Can Use Right Now
• Lean Project Delivery: Leveraging New
ISPE Guides on Commissioning and
Qualification and GAMP®5
• Managing the Risks and Challenges
of Syringe Processing
• Containment Technology Forum: Basics
and Beyond
• Technology Transfer: Focus on the Business
Process and Practical Execution
• Beyond Book-learning: Practical Application
of Good Engineering Practice and Maintenance
Guides
Training Courses
• HVAC for Pharmaceutical Facilities
• Practical Application of Computerized
Systems Compliance: Applying the GAMP 5
Guide: A Risk-Based Approach to Compliant
GxP Computerized Systems
10
ISPE 2010 Tampa Conference At-A-Glance
Table of Contents
22-25 February 2010
Knowledge Elements Reference Chart
Conference Seminar Descriptions
Training Course Descriptions
3
4-11
12-13
Registration Form
14
General Information
15
Table Top Exhibits and Sponsorships
15
Career Café
Visit the Career Café to see the latest
positions available from leading
pharmaceutical and biotechnology employers
and suppliers. Visit www.ISPE.org/careers
for more details.
Grand Hyatt Tampa Bay
Tampa, Florida, USA
Monday,
22 February
Tuesday,
23 February
Wednesday,
24 February
Exhibits Open
17.00 – 18.30
Exhibits Open
07.30 – 16.00
Exhibits Open
07.30 – 16.00
Aseptic Processing of Sterile Products:
Innovations, Regulatory Guidance and
Compliance in a Practical World (E01)
New Members and first time attendees are
cordially invited to this special networking
breakfast hosted by the Membership
Development Committee (MDC). Meet
fellow Society Members and Tampa
Conference attendees to foster new
relationships, learn how to make the most
out of your ISPE membership, and
to ask questions. Bring plenty of business
cards for networking.
Managing the Risks and Challenges of Syringe
Processing (E05)
Inspection Readiness Workshop: From Site Containment Technology Forum:
Preparation to Successful Execution (E02) Basics and Beyond (E06)
OSD – New Guidance You Can Use Right
Now (E03)
Technology Transfer: Focus on the Business
Process and Practical Execution (E07)
Lean Project Delivery: Leveraging New
ISPE Guides on Commissioning and Qualification and GAMP® 5 (E04)
Beyond Book-learning: Practical Application of
Good Engineering Practice and Maintenance
Guides (E08)
HVAC for Pharmaceutical Facilities (T14)
(Monday, Tuesday, and Wednesday)
New Member/First Time
Attendee Orientation
Monday
Thursday,
25 February
Practical Application of Computerized Systems
Compliance: Applying the GAMP®5 Guide: A
Risk-Based Approach to Compliant GxP
Computerized Systems (T11)
Opening Reception
in Exhibit Hall
17.00 - 18.30
Networking Reception
17.00 - 18.30
Certified Pharmaceutical Industry
ProfessionalTM (CPIPTM) Workshops
Introduction Workshops - Monday and Wednesday, 08.00 - 09.00
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 process.
www.ISPE-PCC.org
How-to Workshops - Tuesday and Thursday, 08.00 - 09.00
These complimentary, one hour workshops explain how to submit an eligibility
application and prepare for the examination. Topics include: obtaining a university
transcript, completing the professional experience forms, using the CPIP Study Guide,
and organizing study groups. www.ISPE-PCC.org
2
Applying Solutions to Emerging Industry Challenges
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
Knowledge Elements Reference Chart
1
2
Technical Knowledge
Competency Areas
3
4
5
Product Development
Facilities and Equipment
A
B
C
A
B
C
D
Formulation, clinical phases, and manufacture
A
B
C
A
B
C
A
B
A
B
Materials management
Technology transfer
Production scale-up and optimization
Design and construction/installation
Commissioning and qualification as a risk management strategy
Operation and maintenance
Controls and automation
Information Systems
Supply Chain Management
Production Systems
6
Regulatory Compliance (Drugs, Env.,
Health, and Safety)
7
Quality Systems
Tampa Conference Seminars or Training
Courses
Operational economics
Warehouse and distribution management
Production unit operations - drug (small molecule) and biologics
Production management
Production control
Government regulations
Standards, practices, and guides
Risk management and Quality Management System (QMS)
Systems validation
Technical Knowledge Competency Areas
1
2
3
4
5
6
7
A B C A B C D
A B C A B C A B A B
Aseptic Processing of Sterile Products: Innovations,
Regulatory Guidance and Compliance in a Practical World
X
X
X
Inspection Readiness Workshop: From Site Preparation to
Successful Execution
X
OSD – New Guidance You Can Use Right Now
X
Lean Project Delivery: Leveraging New ISPE Guides on Commissioning and Qualification and GAMP® 5
Managing the Risks and Challenges of Syringe Processing
X
X
X
Containment Technology Forum: Basics and Beyond
Technology Transfer: Focus on the Business Process and
Practical Execution
Beyond Book-learning: Practical Application of Good
Engineering Practice and Maintenance Guides
Practical Application of Computerized Systems Compliance:
Applying the GAMP® 5 Guide: A Risk-Based Approach to
Compliant GxP Computerized Systems
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
All Tampa Conference seminars (and one training course) contain knowledge related to the seven technical knowledge
competency areas for the CPIPTM certification program, an international credential made available through the ISPE
Professional Certification Commission. Completion of any of these seminars does not guarantee successful completion
of the certification exam. Visit www.ISPE-PCC.org for details.
Applying Solutions to Emerging Industry Challenges
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
3
Aseptic Processing of Sterile Products: Innovations, Regulatory
Guidance and Compliance in a Practical World (E01)
Seminar Content Level
Fundamental • Intermediate • Advanced
Attend this two-day seminar to learn about
the latest commercially proven solutions
in aseptic processing. Learn from experts
working in similar environments to yours,
participate in in-depth case study
presentations and discussions, and
network with attendees and presenters.
Topics will cover a range of technologies
for sterile products, from compounding to
inspection, and include:
• Inspection perspectives with respect to
regulatory and industry guidance
• Meeting Annex 1 capping requirements
• Aseptic fill/finish processing
• The “c” in cGMPs?
• Risk-assessment
• Trends in advanced aseptic processing:
isolators and RABS
• X-Ray for inspection of opaque and
freeze dried products
Leaders
• Paul Gold, Director Drug Product
Equipment Technology, Global
Manufacturing Services, Pfizer Global
Manufacturing, USA
• Manmohan Sihra, Director Aseptic
Process Design, Bristol-Myers Squibb,
USA
How You Will Benefit
At the conclusion of this session,
participants will be able to:
Speakers Confirmed to Date
• Massimiliano Barberis, Associate Director, Engineering & Maintenance, Drug
Product, Bristol-Meyers Squibb, ITALY
• Michael Baumstein, Analyst/Microbiologist, Pfizer, USA
• Jeffrey Jackson, Director, Sales North America, Bosch Packaging Technology,
USA
• Madhav Kamat, Senior Principal Scientist, Bristol-Myers Squibb, USA
• Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA
• Jerold Martin, Senior Vice President, Global Scientific Affairs, Pall Life Sciences,
USA
• Michael Miller, Ph.D., President, Microbiology Consultants, LLC, USA
• Michael De La Montaigne, President, Eisai Machinery USA, Inc., USA
• Thomas Ofsharick, GMP Compliance Manager, GlaxoSmithKline, USA
• John Shabushnig, PhD, Senior Manager, Pfizer Quality Operations Center,
Microbiology and Aseptic Support, Pfizer Inc., USA
•Robert Tomaselli, Director, Quality & Process Technologies, Johnson & Johnson,
USA
• Paul Zielinski (BMS) Associate Director, World Wide Quality and Compliance,
Bristol-Myers Squibb, USA
Who Should Attend
Professionals from engineering, operations, quality, planning and project
management
Community of Practice (COP) www.ISPE.org/COPs
Sterile Products Processing
Related Technical Documents, Articles, and Publications
www.ISPE.org/Publications
ISPE Baseline® Guide: Volume 3 - Sterile Manufacturing Facilities
Knowledge Competency Elements
These are detailed on page 3.
Updates and Agenda Online at
www.ISPE.org/2010tampaconference
• Understand different approaches to
compliance with EU Annex 1 in regards to capping environmental requirements
• Understand and effectively apply new
developments in product inspection
• Contrast and analyze alternative
approaches to fill/finish operations
• Apply new technologies in aseptic
manufacturing
4
22-23 February
1.2 CEUs
Applying Solutions to Emerging Industry Challenges
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
Inspection Readiness Workshop: From Site Preparation
to Successful Execution (E02)
Seminar Content Level
Fundamental • Intermediate • Advanced
Would you know the details of planning for
an inspection? This two-day workshop will
not only give you the tools to prepare your
organization for a regulatory inspection,
but will also give you a chance to practice
these skills in a safe and mentoring
environment. This is a highly-interactive
workshop. Attend, be engaged, practice
in a safe setting, and learn.
We have all heard the adage “fail to plan,
plan to fail,” and in no area is this more
relevant than inspection readiness. In our
current economic climate, regulatory
approval and time to market play a major
role in overall product success. Your
competitors are actively monitoring the
outcomes of regulatory inspections and
will try to use this information to their
advantage. This workshop will prepare
you to plan for inspections accurately and
execute them effectively by knowing what
to expect and how to best respond.
The two-day, interactive workshop
addresses the following topics:
• Understanding the purpose of the
inspection and your regulatory filing
• Conducting a quality systems gap
assessment for inspection preparation
• Inspection logistics and site preparations
• Preparing computer and automated
systems for regulatory review
• Special considerations for laboratories
and process equipment
• Utilizing inspection results for competitive
advantage
• Interview techniques including how to
conduct a site tour and how to give a
software demonstration
22-23 February
1.2 CEUs
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Comprehensively understand a site inspection readiness program
• Describe regulatory authorities’ audit processes and the purpose of an
inspection
• Utilize the tools needed to accomplish tasks related to inspection readiness
• Describe specific roles and responsibilities during an audit
• Understand the inspection intricacies associated with laboratories and process
equipment
• Establish yourself as an expert in your functional area
• Formulate effective responses to various types of questioning used by the FDA
and other regulators
• Guide auditors to focus on your quality system’s strengths instead of
weaknesses
Who Should Attend
Professionals from quality assurance, quality control, engineering, regulatory
compliance, quality systems, validation, IT, laboratory, as well as manufacturing
supervisors, and area leaders/managers
Communities of Practice (COPs) www.ISPE.org/COPs
Commissioning and Qualification, and Operations Management
Knowledge Competency Elements
These are detailed on page 3.
Updates and Agenda Online at
www.ISPE.org/2010tampaconference
Leaders and Speakers
• Rebecca Waterbury, ChE, JD, Regulatory
Compliance International, Abbott
Vascular, BELGIUM (Leader)
• Philip Russ, Principal Consultant,
Innovative Consultants, LLC, USA
(Leader)
• Kimberly Snyder, Senior Technical
Manager, Genentech USA
Applying Solutions to Emerging Industry Challenges
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
5
Oral Solid Dosage – New Guidance You Can Use Right Now (E03)
Planned and Implemented by the ISPE OSD Community of Practice (COP)
Seminar Content Level
22-23 February
1.2 CEUs
How You Will Benefit
At the conclusion of this session, participants will be able to:
Fundamental • Intermediate • Advanced
Examine and extract critical perspectives
from warning letters and apply new
industry guidance to benefit your company.
This seminar covers key topics of risk
assessment, adulteration, compliancefocused processes, as well as other key
topics vital for multi-product production
and development. It also focuses on the
entirely new and FDA-reviewed, ISPE
Baseline® Guide: Volume 2 – Oral Solid
Dosage Forms (Second Edition), and
incorporates ideas related to problems
identified in regulatory warning letters from
global agencies.
Breakout sessions using the new OSD
Guide will allow you to discuss with subject
matter experts solutions to real problems
faced in an OSD environment. An FDA
speaker has been invited, and the seminar
will be lead by members of the OSD Guide
writing team.
Note: OSD Guide will be provided as part
of seminar registration.
Leaders
• Stephen Yu, Principle Process Engineer,
BE&K, USA
• Julian Wilkins, Vice President,
PharmaConsult US Inc., USA
• Understand the importance of the new OSD Guide
• Understand how it can help you avoid compliance issues
• Be able to incorporate its elements to improve quality and reduce costs
Speakers Confirmed to Date
• Peter Beke, Facilities Eng Manager, Catalent Pharma Solutions, USA
• J ean-Pierre Bovee, Deputy Director Automation, Sanofi Winthrop Industrie,
FRANCE
• J ack Chu, PE, Manager, Merck & Co Inc, USA
•R
ichard Denk, Director, Pharma Dept, Hecht Technologie GmH/ Kmpt AG,
GERMANY
• David
Jaworski, Consumer Safety Officer, DHHS/FDA/CDER/OC/CMPQ/DCMBNOTE: David will be presenting via web conference
• Steven Ostrove, PhD, President, Ostrove Associates Inc, USA
• John Patterson, Director, IT Compliance, Merck & Co Inc, USA
• Sunil Chand Singhai, Vice President, Dr Reddys Laboratories Ltd, INDIA
• Purna Thakker, Pfizer
• C. Alexander Heisterkamp, IV, Director, Project Eng, Pfizer, USA
• Robert Matje, Senior Director, Pfizer, USA
• Richard Nielsen, Senior Engineer, Catalent Pharma Solutions, USA
Who Should Attend
Anyone involved in OSD manufacturing especially those in generic and contract
manufacturing who may be a risk target of the agencies
Community of Practice (COP) www.ISPE.org/COPs
Oral Solid Dosage
Related Technical Documents, Articles, and Publications
www.ISPE.org/Publications
ISPE Baseline Guide®: Volume 2 – Oral Solid Dosage Forms (Second Edition)
(Available November 2009)
Knowledge Competency Elements
These are detailed on page 3.
Updates and Agenda Online at
www.ISPE.org/2010tampaconference
6
Applying Solutions to Emerging Industry Challenges
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
Lean Project Delivery: Leveraging New ISPE Guides on
Commissioning and Qualification and GAMP® 5 (E04)
22-23 February
1.2 CEUs
Planned and Implemented by the ISPE Commissioning and Qualification (C&Q) and GAMP COPs
Seminar Content Level
Fundamental • Intermediate • Advanced
If you could start your project over again,
what would you do differently? Attend this
seminar to know how to best approach
planning, design, and commissioning and
verification of an integrated system with
integrated deliverables, and how to — at
the same time — meet the intent of the
ISPE Baseline® Guide: Science and
Risk-Based Approach for the Delivery of
Facilities, Systems, and Equipment and
GAMP®5.
Successful project delivery for packaged
equipment with embedded control systems
requires a range of subject matter
expertise. Traditional delivery of such
systems often involves each of the
functional area experts working within their
own silo — producing documents and
executing tests to meet their functional
needs. Furthermore, the approach to such
testing is often equipment-centric and not
process-centric.
Join members of the GAMP and C&Q
COPs for details on how to leverage these
Guides to benefit your projects:
• GAMP 5: Risk-Based Approach to
Compliant GxP Computerized Systems
• ISPE Baseline Guide: Science and
Risk-Based Approach for the Delivery of
Facilities, Systems, and Equipment
Day one of this highly-interactive seminar
examines equipment with an embedded
control system and interaction with
process/sequence controls to demonstrate
a holistic project delivery approach that
integrates multi-system lifecycle activities
to remove unnecessary work. At each
phase of system delivery, a traditional
approach will be challenged and a
synergistic approach proposed. Workshops at each planning step discuss how
to optimize required activities.
Day two features case studies, workshops,
and application of risk-based approaches.
Each day, audience response polling
systems will be used so session leaders
can direct seminar discussion to best meet
attendee needs.
Leaders
• Timothy Howard, PE, CPIP, Director, Commissioning Validation Services,
Commissioning Agents, Inc., USA
• Gregory Ruklic, Principal Engineer Technology & Compliance, Wyeth BioTech,
USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand basic concepts of ASTM E 2500 and GAMP 5 methodology and be
able to effectively apply them
• Apply knowledge gained from the risk assessment process to design a
specification and verification process
• Understand different techniques available to conduct a risk assessment
• Analyze case studies for successful methods and activities that may be applied
to your particular situation
Speakers Confirmed to Date
• Steven Coates, Director Computer Systems QA, Wyeth, USA
• Kevin Martin, Vice President, CimQuest-Vantage LLC, USA
• Armen Nahabedian, Director, Commissioning and Qualification, Wyeth, USA
• Ivan Soto, Validation Manager, Amgen Inc., USA
Who Should Attend
Professionals in commissioning, quality assurance, project delivery, automation
engineering, IT, and validation
Communities of Practice (COPs) www.ISPE.org/COPs
Commissioning and Qualification, and GAMP
Related Technical Documents, Articles, and Publications
www.ISPE.org/Publications
• GAMP 5: Risk-Based Approach to Compliant GxP Computerized Systems
• ISPE Baseline Guide: Science and Risk-Based Approach for the Delivery of
Facilities, Systems, and Equipment (anticipated publication Q1/Q2 2010)
• Commissioning and Qualification: A New ASTM Standard – GMP Regulations by
Robert E. Chew and David Petko
• November/December issue of Pharmaceutical Engineering focused on
Integrated Commissioning and Qualification
• ASTM E 2500
• ISPE Good Practice Guide: Applied Risk Management for Commissioning and
Qualification (anticipated publication Q2 2010)
Knowledge Competency Elements
These are detailed on page 3.
Updates and Agenda Online at
www.ISPE.org/2010tampaconference
Applying Solutions to Emerging Industry Challenges
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
7
Managing the Risks and Challenges of Syringe Processing (E05)
Planned and Implemented by the ISPE SPP Community of Practice (COP)
Seminar Content Level
24-25 February
1.2 CEUs
How You Will Benefit
At the conclusion of this session, participants will be able to:
Fundamental • Intermediate • Advanced
Attend this seminar for global case studies
and interactive workshops on the recent
technologies and solutions.
From the initial decision on which syringes
to process — bulk syringes or presterilized syringes in tubs — to the latest
inspection systems and laser marking
technology, this seminar will present the
latest technologies and trends in many
aspects of syringe processing. Whether
you are in clinical operations or highvolume pharmaceuticals and biologicals,
have existing operations, or are starting
new ones, this seminar will provide
information and practical implications that
can improve quality and increase
productivity.
With syringe filling growing, many
companies are either starting syringe
operations or increasing their throughput.
It is estimated that there are over 2 billion
syringes processed annually now.
Technologies surround syringe processing
operations and are improving with new and
improved equipment and solutions.
• Analyze technologies to improve syringe operations
•Effectively manage risk
• Solve manufacturing challenges
•Implement effective commissioning and qualification practices
• Strengthen supply chain security with newly available technologies
Speakers Confirmed to Date
• Ty Bolt, Component Consultant, Elanco Animal Health, A Division of Eli Lilly and
Company, USA
•Paolo Golfetto, Head of R&D, Glass Division, Nuova Ompi, ITALY
• Karen Hirshfield, Director Regulatory, DHHS/FDA/CDER/OC/DMPQ/RSB
•Didier Laeckmann, Director, New Product Introduction and Process Validation,
Catalent Pharma Solutions, BELGIUM
•Philippe Leyvraz, CEO, Frewitt Printing SA, SWITZERLAND
• Susan Martin, PhD, Senior Principal Consultant, Pharmaceutical R&D, Global
Biologics, Pfizer, Inc.
• Tom Nikolai, Section Head, Biologics, Parenteral Products, Manufacturing
Science and Technology, Abbott
• Thomas Schoenknecht, Director - Drug Product and Device Development,
Amgen
• Oliver Vogt, Director, Process & Equip Engineering, Hospira, Inc., USA
• Wolfgang Weikmann, Director for Validation/Qualification and Visual Inspection,
Vetter, GERMANY
•Scott Young, PhD, Program Director, Crystal Zenith Platform, West
Pharmaceutical Services, USA
Who Should Attend
Case studies and working sessions will
examine the risks and challenges
surrounding syringe processing.
Professionals in syringe technology of any type, as well as those from quality
assurance, quality control, C&Q, maintenance, engineering, supply chain,
materials management, product development, clinical operations, contract
manufacturing, and outsourcing to a contract manufacturer
Leaders
Community of Practice (COP) www.ISPE.org/COPs
• Nancy St. Laurent, CPP, Senior
Supervisor Process Engineering,
Parsons, USA
• Joerg Zimmermann, Director of
Production, Vetter, GERMANY
Sterile Products Processing
Knowledge Competency Elements
These are detailed on page 3.
Updates and Agenda Online at
www.ISPE.org/2010tampaconference
8
Applying Solutions to Emerging Industry Challenges
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
Containment Technology Forum: Basics and Beyond (E06)
Planned and Implemented by the ISPE Containment Community of Practice (COP)
Seminar Content Level
• Two tracks or day one: Fundamental
• Together or day two: Intermediate
Fundamental • Intermediate • Advanced
Facing pharmaceutical containment
challenges? Whether you are looking for
basic information or a more detailed level
of understanding on challenges and
solutions for contained powder processing,
this seminar provides up-to-date
information on hazardous compound
handling processes. On the first day, you
can attend either a fundamental or
intermediate track. Either prepares you to
get the most out of a second day packed
with case studies. Take away a better
understanding of implementation of
containment systems and strategies that
are based on real world experience. Don’t
miss opportunities to hear from, and
network with, industry experts in the field
of containment.
Effective process and equipment design
as well as effective containment practices
at the shop floor level will protect product
from cross-contamination as well as
providing operator protection. Seminar
topics include containment basics,
occupational exposure values, hierarchy of
control, technology examples, contained
sampling, and effective measurement/
testing methods. Day two will include case
studies on various types of facilities, and
will illustrate concepts in practice.
24-25 February
1.2 CEUs
(2 CM Points Awarded for
Industrial Hygienists;
Award #09-3708)
Leaders
• Beth Brock, PE, Consultant Engineer, Eli Lilly & Co., USA
• Alan George, Product Manager, ILC Dover, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Recognize that different types of toxicology limits are set for worker, product,
and environmental protection
• Recognize or describe the following containment concepts: Contain at the
source; Containment challenge; Material migration; and Risk
• Identify containment technologies and their position in the containment
hierarchy
• Recognize applications of hierarchy of containment solutions to real-world
containment challenges
• Describe how other industry professionals solved containment challenges
• Understand new technologies available and how they impact containment
and cross-contamination
Speakers Confirmed to Date
• Paul Egee, Product Manager, IMA North America, USA
• Michelle Frisch, Senior Manager, Global Technical Systems, Powder Systems,
Ltd., USA
• Jonathan Lind, Distinguished Project Engineer, Roche Colorado Corp., USA
• Edwin Melendez, Consumer Safety Officer, DHHS/FDA/CDER/OC/DMPQ/ICB
• Steven Meszaros, Director EHS, Wyeth, USA
• Jimmy Moreno, PE, Senior Project Engineer, Schering-Plough, USA
• Christa Myers, Chemical Process Engineer, CRB Consulting Engineers, Inc.,
USA
• James Wood, PE, Associate Senior Consultant Engineer, Eli Lilly & Co., USA
Who Should Attend
Project/process/manufacturing engineers, environment and health/safety
professionals, quality assurance, professionals from production/manufacturing
operations, professionals from process development, owner/operator, consultants,
and CMOs
Hear the FDA’s perspective, and participate
in a Q&A session on risk-based approaches
for multi-product facilities and highlyhazardous compound containment topics.
Community of Practice (COP) www.ISPE.org/COPs
This seminar is designed for process
and plant engineers, quality and health
and safety professionals, and production
managers, among others, and will provide
a basic understanding of powder
containment concepts as well as fresh
engineering solutions.
www.ISPE.org/Publications
Containment
Related Technical Documents, Articles, and Publications
• ISPE Baseline® Guide: Volume 1 – Active Pharmaceutical Ingredients
• ISPE Knowledge Briefs: Risk-Based Approaches to Cross-Contamination;
Containment Hierarchy of Controls; and Dry Powder Sampling and the
Containment of Hazardous Compounds
Knowledge Competency Elements
These are detailed on page 3.
Updates and Agenda Online at
www.ISPE.org/2010tampaconference
Applying Solutions to Emerging Industry Challenges
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
9
Technology Transfer: Focus on the Business Process and
Practical Execution (E07)
Seminar Content Level
24-25 February
1.2 CEUs
How You Will Benefit
At the conclusion of this session, participants will be able to:
Fundamental • Intermediate • Advanced
It is easy to underestimate the effort
required for effective technology transfer.
As more companies look to outsource
manufacturing operations across the
globe, the timeliness and value of getting it
right is crucial. Technology transfer is more
than just the transfer of a product and/or a
manufacturing process. It is a key tool in a
company’s strategic operation that must be
understood in order to effectively manage.
It is difficult, in part, because it continues to
be underestimated.
This seminar provides an interactive
workshop focused on the execution and
management of technology transfer, both
from a business process and technical
standpoint. It looks at tools and
approaches that foster success. Using the
ISPE Good Practice Guide: Technology
Transfer as a reference tool, subject matter
experts will address:
• Structuring an approach to the business
process of technology transfer
• Formation of a team
• Establishment of good communication
tools
• Setting objectives and acceptance criteria
• Good documentation
• Knowledge transfer across companies,
continents, and cultures
• Analytical methods transfer
• Regulatory compliance; understanding
the regulatory environment
The use of a case study scenario as the
platform for a series of interactive group
workshop activities will bring a real world
element to this seminar, and challenges
attendees to consider both the business
process and technical aspects at the same
time.
• Understand critical elements of technology transfer
• Define goals and objectives that relate to the project objective
• Identify critical business process elements
• Develop a successful team
• Develop effective communication tools
• Understand the critical elements of knowledge transfer
• Identify key regulatory issues
• Develop effective documentation
• Address key business management challenges in technology transfer
• Pull all of the above into an effective technology transfer program
Program Committee Members
• Noel Dinan, Technical Director, API, Schering-Plough, USA
• Michael Denault, Principal, Denault Associates, USA
• Marcella Goodnight, Manager, Genentech, USA
• Larry Kranking, President, Aveta Lifesciences, USA, USA
•D
r. Elaine Morefield, Supervisory Chemist, DHHS/FDA/CDER/OPS/ONDQA/
DPA II
• Daniel Moskey, Associate Director, Vacaville Technology, Genentech, Inc., USA
• Jeffery Odum, Principal, NCBioSource, USA
• James Phillips, Senior Manager - Manufacturing Sciences, Biogen Idec, USA
• Patrick Wong, PE, Director, Asian Operations, IPS, USA
Who Should Attend
Development engineers, process engineers, project managers, quality assurance
and quality control personnel, validation specialists, technology services
managers, process/development chemists, and production managers
Community of Practice (COP) www.ISPE.org/COPs
Process/Product Development
Related Technical Documents, Articles, and Publications
www.ISPE.org/Publications
ISPE Good Practice Guide: Technology Transfer
Knowledge Competency Elements
These are detailed on page 3.
Updates and Agenda Online at
www.ISPE.org/2010tampaconference
Leader
• Michael Denault, Principal, Denault
Associates, USA
10
Applying Solutions to Emerging Industry Challenges
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
Beyond Book-learning: Practical Application of Good Engineering
Practice and Maintenance Guides (E08)
Planned and Implemented by the ISPE C&Q, GAMP, and Project Management Communities of Practice (COPs)
Seminar Content Level
Fundamental • Intermediate • Advanced
Why are there new guides? How will this
information make a difference to my
current role? Take advantage of interactive
workshops and the expertise of
practitioners as attendees and leaders
solve real-life challenges. Even if you
haven’t read the guides, you will be able
to work with leaders who collaboratively
lead the guide team, and other SMEs and
attendees through case studies, topicfocused presentations, and interactive
workshops. This two-day seminar aids the
attendees with hands-on applications to
demonstrate how each of these Guides will
help you in your work.
Good Engineering Practice (GEP), as
a broad collection of engineering and
risk management activities, is becoming
recognized in the pharmaceutical and life
sciences industries as an essential
foundation upon which efficient operations
and regulated activities are built. The ISPE
Good Practice Guide: Good Engineering
Practice provides definitions, examples,
and execution guidance for lifecycle
engineering management applications.
Maintenance has been recognized as an
activity critical to the ongoing success of
manufacturing operations in achieving
productivity goals and sustaining product
quality. Effective maintenance programs
employ multiple elements including
maintenance planning and scheduling,
risk assessments, maintenance approach,
task execution and record keeping among
many others. The ISPE Good Practice
Guide: Maintenance provides definitions,
examples, and guidance for development
and execution of effective, comprehensive
maintenance programs.
24-25 February
1.2 CEUs
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Identify the fundamental components of a comprehensive GEP and an effective
maintenance program
• Understand the importance of GEP as an essential foundation to an effective
manufacturing operation
• Analyze and understand the benefits and challenges associated with
maintenance programs
• Interpret and understand how to utilize the GEP and Maintenance Good Practice
Guides to develop or improve engineering and maintenance program activities in
your own organization
• Deliberate on the current trends associated with GEP and maintenance activities
Presentations and Speakers Confirmed to Date
• FDA Invited
• Donna DeFreitas, Senior Associate, Genesis Engineers Inc, USA
• Mark Foss, Head of Engineering, Boehringer Ingelheim Ltd, UNITED KINGDOM
• Keith Gibbs, Corporate Manager, C&Q, Yonkers Industries, USA
• Bob Lennon, Director, Americas Region, Abbott Laboratories, USA
Who Should Attend
Professionals from engineering, maintenance, engineering excellence, quality,
operations, commissioning and qualification, validation, capital projects, and
project management
Communities of Practice (COPs) www.ISPE.org/COPs
Commissioning and Qualification, GAMP, Project Management, and Operations
Management
Related Technical Documents, Articles, and Publications
www.ISPE.org/Publications
ISPE Good Practice Guide: Good Engineering Practice and ISPE Good Practice
Guide: Maintenance
Knowledge Competency Elements
These are detailed on page 3.
Updates and Agenda Online at
www.ISPE.org/2010tampaconference
Leaders
• Daniel Franklin, Regional Manager,
Compliance Services, IPS, USA
• Remitha Jones, Principal Engineer,
Abbott, USA
Applying Solutions to Emerging Industry Challenges 11
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
HVAC for Pharmaceutical Facilities (T14)
Training Course
Course Content Level
Fundamental • Intermediate • Advanced
This course will provide a detailed
description of HVAC system fundamentals,
including a discussion of primary system
components such as fans, coils,
humidifiers, and filters. Participants will
receive an overview of critical parameters
for products and processes that can be
affected by HVAC, and explore the basic
concepts of controlling these parameters
using properly designed HVAC control
systems. Participants will discuss what
HVAC can and cannot do to maintain good
manufacturing practices (GMPs) as they
are addressed for facilities designed
to manufacture bulk pharmaceutical
chemicals (BPC), oral solid dosage
(OSD) products, sterile products, and bulk
biopharmaceuticals. HVAC systems for
production laboratories and warehouse
facilities utilized for the storage of product,
raw materials, and components are also
covered.
On completion of facility-specific systems,
the requirements for commissioning and
qualification are explored with emphasis on
distinguishing between critical and
noncritical parameters. Other course topics
include HVAC controls, monitoring of
critical parameters, and system
construction. Dust collection systems and
laboratory fume hoods are not covered,
as these systems are addressed by other
sources. The course concludes with
suggestions for system maintenance.
Take Back to Your Job How To ...
• Define basic HVAC system concepts
• Discuss HVAC system-critical parameters that must be controlled and monitored
• Distinguish among pharmaceutical cleanroom air classifications and explain how they
are applied
• Explain the role of HVAC in protecting products
• Examine typical HVAC system designs used for bulk, oral solid dosage, sterile,
biopharmaceutical, and packaging and warehousing operations
• Understand the basics of process laboratory HVAC
• Describe HEPA filter theory, application, monitoring, testing, and repair
• Cite HVAC maintenance requirements
Who Should Attend
• Project engineers, HVAC technicians and mechanics, HVAC control designers,
commissioning personnel, government agency inspectors, quality assurance
specialists, and manufacturing managers
• Professionals needing a thorough understanding of HVAC systems utilized in
pharmaceutical operations
• Engineering professionals and other consultants who work with the pharmaceutical
industry
Instructor
Norm Goldschmidt, Principal/Founder, Pharma Engineering Advisors, USA
Community of Practice (COP) www.ISPE.org/COPs
HVAC
Related Technical Documents, Articles, and Publications
www.ISPE.org/Publications
ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning
Attendees will be provided with updates
to course materials if GMPs or technology
related to meeting GMPs change within
12 months of attending the course (email
address required).
Participants should be familiar with basic
pharmaceutical product forms and GMPs.
Note: Course registrants receive a copy of
the ISPE Good Practice Guide: Heating,
Ventilation, and Air Conditioning.
12
22, 23 and 24 February
2.0 CEUs
Applying Solutions to Emerging Industry Challenges
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
Practical Application of Computerized Systems Compliance:
Applying the GAMP®5 Guide: A Risk-Based Approach to Compliant
GxP Computerized Systems (T11) — Training Course
Course Content Level
Fundamental • Intermediate • Advanced
This highly-interactive workshop provides
hands-on experience in applying practical
techniques and solutions to solve
computerized systems compliance
challenges. Participants will discuss and
analyze case studies, apply newly acquired
knowledge to hypothetical case-study
systems, and have the opportunity to
discuss their own real-life challenges with
other participants and an expert trainer.
Participants should come prepared to work
in groups to devise workable and creative
solutions to realistic problems and case
study scenarios, facilitated by the
instructor.
GAMP guidance aims to achieve
computerized systems that are fit for
intended use and meet current regulatory
requirements, by building upon existing
industry good practice in an efficient and
effective manner. The course outlines the
importance of applying a documented and
justified risk-based approach to computer
systems compliance.
Highlights of the course include:
• Overview of key themes/concepts in
GAMP 5
• Understanding the process and overall
GxP Risk
• Effective planning for compliance
• Supplier assessment and leveraging
supplier knowledge and documentation
• The key role of clear and complete user
requirement specifications
• Choosing a suitable specification and
verification approach
• GAMP 5 quality risk management
approach (based on ICH Q9)
• Specific risk assessment tools for
computerized systems
• Selecting a suitable lifecycle and scaling
the lifecycle based on risk, complexity,
and novelty
• Developing a strategy and writing a
computerized system validation plan
• Writing high-quality test scripts
• Maintaining the control in operation –
a scaleable approach
• Regulatory hot topics
24-25 February
1.5 CEUs
This course was developed by members of the ISPE GAMP Community of
Practice. GAMP was established by industry leaders to interpret and improve the
understanding of regulations governing the use of computerized systems in
pharmaceutical manufacturing.
Note: Course registrants receive a copy of the GAMP® 5 Guide: A Risk-Based
Approach to Compliant GxP Computerized Systems.
Take Back to Your Job How To ...
•Build upon and expand understanding of the regulatory requirements and
expectations for the compliance of computerized systems used in pharmaceutical
manufacturing
• Apply this understanding to example systems and case studies
• Analyze case studies and apply the GAMP 5 process for achieving compliance
and fitness for intended use
• Apply quality risk management and risk assessment concepts
Who Should Attend
• Quality assurance and quality control specialists, validation specialists,
manufacturing supervisors, technical support personnel, engineers, MIS
professionals and all levels of management who need a practical understanding
of computerized system compliance
• Computer system vendors or consultants, engineering contractors, and validation
service companies
• Those who have previously attended a GAMP Basic Principles training course or
those whose practical experience has provided the equivalent level of knowledge
Instructor
James W. (Jim) John, Project Manager, Altus Automation, a ProPharma Group
Company, USA
Community of Practice (COP) www.ISPE.org/COPs
GAMP
Related Technical Documents, Articles, and Publications
www.ISPE.org/Publications
GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized
Systems
Knowledge Competency Elements
These are detailed on page 3.
Important Course Notes
This course includes a pre-recorded, Web-based session providing a review of
basics prior to the classroom course.
Applying Solutions to Emerging Industry Challenges 13
22-25 February 2010 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
ISPE 2010 Tampa Conference
Applying Solutions to Emerging Industry Challenges
Registration Form • 22-25 February 2010
Please type or print clearly.
ONLINE: www.ISPE.org/2010TampaConference FAX: +1-813-264-2816
MAIL: ISPE, 3109 W. Dr. Martin Luther King Jr. Blvd., Suite 250, Tampa,
Florida, 33607 USA
ISPE ID # _______________________________
Check here
if you were previously an ISPE Member.
First Name __________________________________________________MI _________ Last Name ______________________________________________________________
Informal Badge Name ______________________________________________________ Chapter/Affiliate _________________________________________________________
Job Title ___________________________ Email Address __________________________________________________Company ______________________________________
Business Address ________________________________________________________________________________________________________________________________
City __________________________________________State/Province__________________ Zip+4/Postcode ____________________ Country ___________________________
Business Tel _____________________________________________________________ Business Fax ___________________________________________________________
Emergency phone for last minute meeting updates: Cell Phone ______________________________________ or Home Phone ________________________________________
I wish to keep my data confidential and it is given only for use by ISPE and its local Chapters and Affiliates.
I do not wish my information to be printed in the Membership Directory or on Conference Attendee Listings.
First Time Attendee
New Member
New Member/First Time Attendee Orientation
HOTEL: Hotel accommodations and hotel fees are separate from Conference registration fees. For room reservations at the Conference venue, Grand Hyatt Tampa Bay, call
tel: +1-813-874-1234. When making your reservation by phone, mention ISPE for a discounted rate of $229 single/double (total with tax $256.48). This rate is good until 26 January
2010, or until the room block is full, whichever comes first. Please contact the hotel as early as possible to make your reservations to ensure you are in the headquarters hotel.
Please Select Your Seminars of Choice
E01
Aseptic Processing of Sterile Products: Innovations, Regulatory
Guidance and Compliance in a Practical World - Monday and
Tuesday
E05
Managing the Risks and Challenges of Syringe
Processing - Wednesday and Thursday
E02
Inspection Readiness Workshop: From Site Preparation to
Successful Execution - Monday and Tuesday
E06
Containment Technology Forum: Basics and Beyond Wednesday and Thursday
E03
Oral Solid Dosage: New Guidance You Can Use Right Now Monday and Tuesday
E07
Technology Transfer: Focus on the Business Process
and Practical Execution - Wednesday and Thursday
E04
Lean Project Delivery: Leveraging New ISPE Guides on
Commissioning and Qualification and GAMP®5 Monday and Tuesday
E08
Beyond Book-learning: Practical Application of Good
Engineering Practice and Maintenance Guides Wednesday and Thursday
INDIVIDUAL SEMINAR REGISTRATION FEES — PLEASE CIRCLE
PAYMENT Discounts cannot be combined.
Regular/Onsite (After 25 January)
First Two-day Seminar Fee
Current Member
New Member* (Fee includes one-year ISPE Membership, a $215 value)
Nonmember
$ 1,350
$ 1,565
$ 1,645
Additional Two-day Seminar Fee (save 20%)
Current Member
Nonmember
$ 1,080
$ 1,315
Student Member Fee
$ 150
Regulatory Authority/Government — Two-day Seminar Fee
$ 675
Academia/Emerging Economy Member — Two-day Seminar Fee
$ 675
Committee Member — Two-day Seminar Fee
$ 525
Please Select Your Training Course(s) of Choice and Circle Payment
PLEASE NOTE:
Multiple attendees
from a company who
register at the same
time qualify for a
discount. The following
savings are taken from
fees: 3-5 delegates
10%, 6-10 delegates
15%, and 11+
delegates 20%.
Regular/Onsite (After 25 January)
T14
HVAC for Pharmaceutical Facilities Monday, Tuesday, and Wednesday
Current Member
New Member* (Fee includes one-year ISPE Membership, a $215 value)
Nonmember
$ 2,285
$ 2,500
$ 2,625
T11
Practical Application of Computerized Systems Compliance:
Applying the GAMP®5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems - Wednesday and Thursday
Current Member
New Member* (Fee includes one-year ISPE Membership, a $215 value)
Nonmember
$ 1,910
$ 2,125
$ 2,230
T04
Pharmaceutical Water Generation
Monday and Tuesday
Current Member
New Member* (Fee includes one-year ISPE Membership, a $215 value)
Nonmember
$1,910
$2,125
$2,230
SPECIAL LUNCH REQUIREMENT —
Vegetarian
Kosher
Gluten Free
PAYMENT METHOD — REGISTRATIONS REQUIRE PAYMENT ATTACHED
Substituting for __________________________________ (NONMEMBERS SUBSTITUTING FOR A MEMBER MUST PAY THE DIFFERENCE IN FEES.)
Check enclosed payable to ISPE # __________________ in the amount of $ ________________ (must be drawn on a US bank)
Bill credit card — circle type:
VISA
MC
AMEX
Card number _____________________________________________________ Exp. date _______________________
Name of cardholder___________________________________________________________________________
(AS IT APPEARS ON CARD)
Please send registration form
with payment to:
ISPE Headquarters, 3109 W. Dr.
Martin Luther King Jr. Blvd., Ste.
250,Tampa, Florida 33607 USA
Tel: +1-813-960-2105 • Fax:
+1-813-264-2816 • FEIN
#59-2009272 • www.ISPE.org
Cardholder signature ___________________________________________________________________________________________
TPACONF09-Broch2
*To activate your membership please download a membership application at www.ISPE.org/membership and return it to ISPE with this conference registration
form. Membership is non-transferable. This is a 30-day limited offer from time of conference end date.
Registration is confirmed only when payment is received.
Conference Cancellations - Cancellations must be made in writing. If cancellations are received by 1 February 2010, a full refund, minus a 10% handling fee (maximum of $100), will be
issued. After that time, no refunds will be granted. If you are unable to attend, substitutions will be accepted. However, nonmembers substituting for a Member must pay
difference in fees prior to the start of the event. ISPE is not responsible for lost airfare due to cancellations.
Regform_update.indd 1
1/28/2010 9:19:33 AM
General Information
How to Register
ISPE Bookstore
Online: Visit www.ISPE.org/2010tampaconference
Visit the ISPE Bookstore at Tampa Conference to stock up on the
latest technical publications from ISPE. Members receive a 20
percent discount onsite.
Via Fax: Complete the registration form and fax it to: +1-813-264-2816
Via Mail: Complete the registration form and mail it with payment to:
ISPE Headquarters, 3109 W. Dr. Martin Luther King Jr. Blvd.,
Suite 250, Tampa, Florida 33607 USA
Questions? Call ISPE at tel: +1-813-960-2105, or email: ask@ispe.org
Written confirmation will be sent to you after your registration is
processed (time permitting). In order to be listed in the official delegate
roster, you must be registered and paid by 11 February.
Conference Fees Include
Exhibit Hall access, continental breakfasts, refreshment breaks, lunches,
and networking receptions. Hotel accommodations and hotel fees are
separate from Conference registration fees.
For room reservations at the Conference venue, Grand Hyatt Tampa
Bay, call tel: +1-813-874-1234. When making your reservation by phone,
mention ISPE for a discounted rate of $229 single/double (total with
tax $256.48). This rate is good until 26 January 2010, or until the room
block is full, whichever comes first. Please contact the hotel as early as
possible to make your reservations to ensure you are in the headquarters
hotel. We thank you for staying at the Hyatt as this enables ISPE to meet
contract requirements. Complimentary daily Internet cards are available
for ISPE attendees at the hotel front desk.
Conference Schedule
The registration desk will be open: Sunday 15.00 - 17.00; Monday Wednesday 07.30 - 17.30; and Thursday 07.30 - 16.00. Seminars are
scheduled to begin at 09.00 and conclude at 17.00 from Monday to
Wednesday. Thursday seminars begin at 08.00 and conclude at 16.00.
Morning and afternoon breaks are scheduled daily. Lunch will be served
each day. A la carte lunch tickets may be purchased separately onsite.
Conference Cancellations
Cancellations must be made in writing. If cancellations are received by
1 February, a full refund, minus a 10% handling fee (maximum of $100),
will be issued. After that time, no refunds will be granted. If you are
unable to attend, substitutions will be accepted. However, nonmembers
substituting for a Member must pay difference in fees prior to the start of
the event. ISPE is not responsible for lost airfare due to cancellations.
Accreditation
ISPE provides continuing education units (ISPE CEUs). ISPE CEUs are
nationally recognized units of attendance that identify those individuals
continuing their education in their chosen field or profession. For the E06,
Containment Technology Forum, CM Points for industrial hygienists have
been applied for.
Special Requirements
If you require special accommodations to participate, such as a
wheelchair-accessible room or a sign language interpreter, please attach
a written description of your needs to your registration form. If you have
questions, please contact ISPE at tel: +1-813-960-2105 or email: ask@
ispe.org. Please mark vegetarian, gluten free, or kosher, if needed, in
the Special Meal Requirement box on the registration form.
Notice
ISPE leaders and speakers are leading professionals in their fields.
However, in those rare circumstances where we find it necessary
to make subsitutions, every possible effort is made to provide
speakers with comparable qualifications. Agendas are subject
to change without notice. Every precaution is taken to ensure
accuracy, but ISPE cannot accept responsibility for the accuracy
of information distributed or contained in these seminars or for any
opinion expressed. Delegates’ names and addresses may be given
as part of a list to other organizations for purposes related to the
field of pharmaceutical manufacturing. If you do not wish to receive
other related information, please notify ISPE.
Know Before You Go
Visit www.ISPE.org/2010tampaconference prior to attending the
Conference for all you need to “Know Before You Go.” You will
receive an email one week prior to the event with updated details, a
delegate roster, and more.
Get Your Space at the Table Top Exhibition
The Table Top Exhibition is a popular marketing and business
development tool that guarantees excellent exposure for your
company. Don’t miss out on this opportunity to meet face-to-face
with key decision makers in the pharmaceutical and biotechnology
manufacturing industries.
Exhibit set up will be on Monday, 22 February from 12.00 - 16.00.
The exhibits will open on Monday, 22 February from 17.00 - 18.30
with the Opening Reception. Continental breakfast and
refreshment breaks will be held in the Exhibit Hall on Tuesday
and Wednesday.
The fee to exhibit is $2,300 and includes two exhibitor badges for
each exhibiting company. The table top exhibition will be limited to
60 companies.
Exhibit cancellations made prior to 28 December 2009 will result in
a $500 cancellation fee. There are no refunds for exhibit
cancellations made after 28 December 2009.
Contact John Phillips at jphillips@ISPE.org, or Valerie Adams
at vadams@ISPE.org.
Sponsorships
ISPE Conference Sponsorships offer your company unique
opportunities to build and reinforce name recognition, create
top-of-mind brand awareness, and develop new business. These
sponsorships provide an opportunity for you to connect with a
targeted, unique, and global audience, promote the latest technical
advancements, and demonstrate your company’s commitment to
the education of pharmaceutical and biotechnology manufacturing
industry professionals. Host, Platinum, Gold, Silver, and Bronze
Top Tier Sponsorships are available as well as cyber café,
lanyards, and hotel keycards. Onsite advertising opportunities are
also available. Contact John Phillips at jphillips@ISPE.org,
or Valerie Adams at vadams@ISPE.org for details.
15
NON-PROFIT ORG.
U.S. POSTAGE
PAID
engineering pharmaceutical innovation
TAMPA, FL
PERMIT NO. 2661
3109 W. Dr. Martin Luther King Jr. Blvd.,
Suite 250 | Tampa, FL 33607
The ISPE 2010 Tampa Conference
Education Seminars
• Aseptic Processing of Sterile Products: Innovations, Regulatory Guidance
and Compliance in a Practical World
• Inspection Readiness Workshop: From Site Preparation to Successful
Execution
• Oral Solid Dosage: New Guidance You Can Use Right Now
• Lean Project Delivery: Leveraging New ISPE Guides on Commissioning and
Qualification and GAMP®5
• Managing the Risks and Challenges of Syringe Processing
• Containment Technology Forum: Basics and Beyond
• Technology Transfer: Focus on the Business Process and Practical Execution
• Beyond Book-learning: Practical Application of Good Engineering
Practice and Maintenance Guides
Skill-building Training Courses
• HVAC for Pharmaceutical Facilities
• Practical Application of Computerized Systems Compliance: Applying the
GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized
Systems
ISPE Membership:
Knowledge, Community,
Profession, and More
Find out what becoming an ISPE Member can
do for you. New Member registration fees
include a one-year ISPE membership. Visit
www.ISPE.org/join to learn more about the
many benefits of ISPE Membership.
Sponsorship and
Table Top Exhibit
Opportunities Available!
For details, see page 15 of this brochure or
contact John Phillips at jphillips@ISPE.org, or
Valerie Adams at vadams@ISPE.org for more
information.
www.ISPE.org/2010tampaconference