ISPE and FDA present
Redefining the C
in CGMP
“
”
Creating, Implementing and Sustaining
a Culture of Compliance
4 – 5 June 2012
Baltimore, Maryland
Renaissance Baltimore
Harborplace Hotel
ISPE.org/2012CGMP
Welcome
Schedule-At-A-Glance
Monday, 4 June
FDA has joined with ISPE to deliver an
integrated learning conference focused on
Industry and Regulatory viewpoints.
Join us in Baltimore, Maryland to hear
from global regulators, health and trade
organizations as they discuss evolving
compliance issues, improving good
manufacturing practices and how to
navigate in today’s pharmaceutical industry.
The Conference will kick off on Monday
morning with FDA speakers and industry
experts addressing hot topics and the future
of compliance during the Plenary Sessions.
Attendees will then choose from content-rich
education sessions and participate in two
new interactive special events–Industry-Led
Hot Topic Discussion Forum and Meet the
Press.
You won’t want to miss this rare, behindthe-scenes look at the FDA’s views as they
relate to CGMP.
07.30 – 09.00
Continental Breakfast
09.00 – 09.45
Plenary Session 1 – V
ision for Quality in the 21st Century
09.45 – 10.30
Plenary Session 2 – Lean Manufacturing Without
Compromising Quality
Janet Woodcock, Director CDER, FDA, USA
Andy Skibo, Executive Vice President, Operations, MedImmune, USA
10.30 – 11.00
Networking Break
11.00 – 12.15
1A
12.15 – 13.15
Lunch
13.15 – 14.00
Plenary Session 3 – G
lobal Quality
14.00 – 15.30
2A
15.30 – 16.00
Networking Break
16.00 – 17.00
Forum 1: Industry-Led Hot Topic Discussion Forum
17.00 – 18.30
Networking Reception in Exhibit Hall
Benefits of PAI Readiness and Data
Integrity for Speedy Approvals
1B Why It Pays to Continually Reinvest
in Your Facilities & Systems
Deborah Autor, Deputy Commissioner for Global Regulatory
Operations and Policy, FDA, USA
egulatory Success in a Cloud
R
Environment
2B Sustaining Compliance Consistency
throughout Your Supplier Networks
Tuesday, 5 June
07.00 – 08.00
Continental Breakfast
08.00 – 08.45
Plenary Session 4 – Future Vision for the Office of Compliance
08.45 – 09.30
Plenary Session 5 – Culture of Quality
09.30 – 10.15
Plenary Session 6 – International Regulatory Perspective
10.15 – 11.00
Networking Break in Exhibit Hall
11.00 – 12.30
3A
12.30 – 13.30
Lunch
13.30 – 14.30
Forum 2: Meet the Press
14.30 – 15.15
Networking Break in Exhibit Hall
15.15 – 17.00
4A
Ilisa Bernstein, Acting Director, Office of Compliance, CDER, FDA, USA
Mary Oates, Vice President of Global Quality Operations, Pfizer, USA
Gerald Heddell, Director of Inspection, Enforcement and Standards,
MHRA, UK
Watching Your Process – Assuring
Quality and Process Performance
Flexible Manufacturing
3B Quality Risk Management: Using
Risk Assessments in Manufacturing
4B
CAPA: Case Studies
Special Events
Industry-Led Hot Topic
Discussion Forum
Monday, 4 June
16.00 – 17.00
Industry leaders and FDA regulators will facilitate
an attendee group discussion to identify critical
industry issues, concerns, needs for clarity, and
opportunities for collaboration.
Moderator:
Brian Lange, Operations Director, Merck
Manufacturing Division, North American
Operations and Consumer Care, Merck, USA
Meet the Press
Tuesday, 5 June
13.30 – 14.30
A distinguished panel of regulators and industry
experts will answer questions about how
to drive patient safety, product quality and
compliance throughout organizations, and how
the pharmaceutical industry and regulatory
agencies can work effectively in achieving these
mutual goals. This thought-provoking session is
intended to open a dialog on issues and future
direction and will be driven by industry, agency
and audience questions. The expert moderators
represent the pharma industry technical press,
business and public media teaming to deliver a
high value, engaging discussion.
Press Moderators include:
Jeff Salkin, Host of Direct Connect, Maryland
Public Television, USA
Bill Paulson, Editor-in-Chief, International
Pharmaceutical Quality, USA
Judy Leon, Senior Communications Advisor,
CDER, FDA, USA
Networking Events
New Member/First-Time Attendee Breakfast
Monday, 4 June
07.30 - 8.45
Join us for this special networking breakfast hosted by the Membership Development Committee.
Meet fellow Society Members during breakfast to foster new relationships, learn about ISPE and
find out how to make the most out of your membership!
Networking Reception
Monday, 4 June
17.00 – 18.30
Take this opportunity to talk with key regulators, industry leaders and big decision makers in an
informal setting. Enjoy refreshments and conversation while meeting fellow pharma professionals,
building your network of new friends and colleagues and discussing today’s hot industry topics
with people working in every aspect of the industry.
ISPE Chesapeake Bay Area Chapter Proudly Presents
Riverboat Night Cruise
Tuesday, 5 June
19.00 – 22.00
Climb aboard the Black-Eyed Susan, to experience Baltimore’s only authentic paddlewheel driven
dinner riverboat. Enjoy the open bar, pasta station, local favorite appetizers including shrimp,
crab cakes, hot crab dip and carved tenderloin.
The Victorian-style paddleboat is only steps away from the Renaissance Harborplace Hotel.
Boarding begins 30 minutes prior to departure. Don’t miss a chance to experience a little of
Baltimore’s Inner Harbor, while mingling with colleagues from the Chesapeake Bay Area Chapter
and other conference attendees. Visit the ISPE website to book your spot today!
Members: $90
NonMembers: $100
Plenary Sessions – Monday, 4 June
ISPE and the FDA present a substantial line up of the top regulatory and industry
professionals speaking on the key issues affecting pharma today.
Plenary Session 1 – 09.00 – 09.45
Plenary Session 2 – 09.45 – 10.30
Plenary Session 3 – 13.15 – 14.00
Vision for Quality in the
21st Century
Lean Manufacturing
Without Compromising Quality
Global Quality
presented by
Janet Woodcock
Director CDER, FDA, USA
Janet Woodcock is the director of the Center for Drug
Evaluation and Research (CDER) at the FDA. She
introduced the concept of risk management in 2000 as
a new approach to drug safety. Since 2002, she has
led the “Pharmaceutical Quality for the 21st
Century Initiative,” the FDA’s highly successful effort
to modernize drug manufacturing and its regulation.
In 2004, she introduced FDA’s “Critical Path” Initiative,
which is designed to move medical discoveries from
the laboratory to consumers more efficiently. Most
recently, Dr. Woodcock launched the “Safety First” and
“Safe Use” initiatives designed to improve drug safety
management within and outside FDA, respectively.
Dr. Woodcock previously served as FDA’s deputy
commissioner and chief medical officer. Prior to joining
CDER she oversaw approval of the first
biotechnology-based treatments for multiple sclerosis
and cystic fibrosis.
presented by
presented by
Andy Skibo
Deborah Autor
Executive Vice President,
Operations, MedImmune, USA
Deputy Commissioner for Global Regulatory
Operations and Policy, FDA, USA
Andrew D. Skibo is executive vice president of
operations at MedImmune, and leads various
projects, works with external partners and continues
to strengthen the Operations Management Team. In
2007, he joined MedImmune as senior vice president,
engineering, and was responsible for overseeing largescale capital projects at all of MedImmune’s facilities,
including several sites in the US, the Netherlands and
the UK. Previously, Andrew held the position of vice
president, corporate engineering and capital projects
at Amgen, Inc. Beforehand, he served in engineering
management positions focused on pharmaceuticals
and bioscience at Skanska, Inc; Foster Wheeler
Corp.; Life Sciences International, Inc.; A.D. Skibo
& Associates, Inc.; and Genentech, Inc. He holds a
master of science degree in chemical engineering, and
a bachelor of science degree in organic chemistry, both
from Massachusetts Institute of Technology.
Deborah M. Autor is the FDA’s Deputy Commissioner for
Global Regulatory Operations and Policy. Ms. Autor’s
Directorate, one of four created in July 2011, includes
the Office of Regulatory Affairs (ORA) and the Office
of International Programs (OIP). Recently, she was
awarded the 2011 Meritorious Executive Presidential
Rank Award. In addition, she leads the FDA’s strategy
for confronting challenges of globalization and import
safety. She has co-chaired the group that prepared the
FDA’s June 2011 report on Pathway to Global Product
Safety and Quality1, which describes the paradigm shift
that FDA must make in order to face the challenges of
globalization today, and in the future. Prior to assuming
the role of Deputy Commissioner, she served for five
years as Director of the Office of Compliance of FDA’s
Center for Drug Evaluation and Research.
ISPE.org/2012CGMP
Plenary Sessions – Tuesday, 5 June
Plenary Session 4 – 08.00 – 08.45
Plenary Session 5 – 08.45 – 09.30
Plenary Session 6 – 09.30 – 10.15
Future Vision for the Office
of Compliance
Culture of Quality
International Regulatory
Perspective
presented by
presented by
Ilisa Bernstein
Acting Director, Office of
Compliance, CDER, FDA, USA
Dr. Ilisa Bernstein is the Acting Director of the Office
of Compliance in the Center for Drug Evaluation and
Research at the FDA. Previously, she was the Deputy
Director of the Office of Compliance. In 2006, she
was the Director of Pharmacy Affairs at the FDA, and
between 2003 and 2006, she was Senior Advisor
for Regulatory Policy. From 1991 to 2002, she was
a Senior Science Policy Advisor in the Office of the
Commissioner. From 2002 until 2003, she was a
Senior Associate Director at Pfizer, where she served
as a liaison between Pfizer and the FDA. She provided
guidance and advice on emerging policies, regulations,
and legislation. Ilisa completed a post-doctoral
residency at the National Institutes of Health. Also, she
has a Doctor of Pharmacy degree from The University
of Michigan College of Pharmacy, and a Juris Doctor
degree from The American University Washington
College of Law.
presented by
Mary Oates
Vice President of Global
Operations, Pfizer, USA
Mary Oates is Vice President of Global Quality
Operations for Pfizer. In this role, she is responsible
for Quality oversight of all products made by and for
Pfizer for both clinical and commercial use. She holds
an undergraduate degree in biochemistry and a Ph.D.
in analytical chemistry. Oates is actively involved in
industry initiatives that are aimed at enhancing product
quality.
Gerald Heddell
Director of Inspection, Enforcement
and Standards, MHRA, UK
Gerald Heddell took up the post as Director of the
Inspection and Standards (I&S) Division on 4 January
2005.
Gerald is a microbiologist who is a Chartered Biologist
and a member of the Institute of Biology and the
Royal Society of Chemistry. Since leaving the NHS in
1978, he has worked in a succession of progressively
senior roles in manufacturing and quality assurance
for The Wellcome Foundation, Glaxo Wellcome and
GlaxoSmithKline. Gerald has experience in most
aspects of pharmaceutical manufacture and control,
with a particular interest in sterile products.
Don’t miss these premier presentations focused on global quality, worldwide
compliance and the future vision of the pharmaceutical industry. Here’s your
opportunity to hear directly from the policy makers and influencers affecting business and
manufacturing in the 21st century.
ISPE.org/2012CGMP
Education Sessions – Monday, 4 June Morning Sessions
Session 1A
Benefits of PAI Readiness and Data Integrity for Speedy Approvals
FDA’s pre-approval inspection program provides FDA with assurance that a manufacturing establishment
is capable of manufacturing a drug and that submitted data are accurate and complete. There are
three primary inspectional objectives of this PAI program which include: determine readiness for
commercial manufacturing; assess conformance to the application; and perform a data integrity audit.
The session will focus on typical coverage performed during a pre-approval inspection in order to
better prepare you for such an inspection. Examples of data integrity issues found during an inspection
and FDA’s experience with applications utilizing a Quality by Design (QbD) approach will be described.
At the conclusion of this session, participants will be able to:
• Understand and anticipate what an FDA investigator will cover during a pre-approval inspection
• Understand what some of the common inspection issues are that are cited on a 483 at the
conclusion of pre-approval inspections
• Understand how to prepare for a pre-approval inspection
• Understand the CGMP issues relating to implementation of QbD for manufacturing of drug
products and some findings related to QbD for FDA inspections
• Understand how FDA assesses data integrity and understand some of the recent data integrity
issues uncovered during inspections and the resulting regulatory actions
• Prepare higher-quality facility evaluation applications based on tips learned in this session
Moderator: J. David Doleski, Acting Director, Division of Good
Manufacturing Practice Assessment, OMPQ, OC, CDER,
FDA, USA
11.00 – 11.30 Inspection Readiness Issues
11.30 – 12.00 Field Inspector Perspective
12.00 – 12.15 Q&A
Session 1B
Why It Pays to Continually Reinvest in Your Facilities and Systems
It’s a fact that antiquated, run-down facilities have a difficult time producing high-quality/fit-for-use
products. Like any process, the manufacturing facility has its own lifecycle. If the facility is not reliable,
the process will not be well supported and unexpected variation will be introduced. A manufacturer
has the responsibility to take good care of their facilities, as well as the equipment and infrastructure
inside the facility.
This session will emphasize why it is so important to continually reinvest in your facility throughout its
lifecycle. A practical industry case study will be presented to illustrate the tangible business and quality
benefits that lead to tangible bottom-line results that not only ensures that patients receive the product
that they are relying on, but also the shareholders receive a return on their investment.
At the conclusion of this session, participants will be able to:
• Understand the risks of outdated or inadequately maintained facilities
• Understand why prevention is a strategic advantage when it comes to facility upkeep
• Learn the advantages of planning ahead and keeping your facilities in line with
contemporary technology
• U
nderstand how a facility, just like a process, needs lifecycle management to maintain a
state of control
Moderator: Steven Lynn, Acting Director, Office of Manufacturing
and Product Quality, OC, CDER, FDA, USA
11.00 – 11.30 Quality is Free - Benefits of
Keeping
Facilities Current
11.30 – 12.00 The Advantages of Proactive
Facility Management
12.00 – 12.15 Q&A
ISPE.org/2012CGMP
Afternoon Sessions
Education Sessions – Monday, 4 June
Session 2A
Regulatory Success in a Cloud Environment
Life science companies have outsourced many aspects of their manufacturing and research
processes for years. The outsourcing trend has also hit the IT world in the past decade. Most recently,
a combination of cost factors and technological progress has made “cloudsourcing” an economically
enticing option. The life science industry has long believed that they had different requirements for
information management than other industries. But is that true?
This session will examine some potential pros and cons for maintaining regulated data in the cloud and
will address the information security triad that defines the requirements for a cloud solution: how can
you assure adequate confidentiality, availability and integrity of data.
At the conclusion of this session, participants will be able to:
• Understand the advantages and disadvantages of embracing a cloud solution
• U
nderstand how other industries have addressed many of the same issues that face life science
companies
• L earn how the right cloud provider can provide equivalent and in some cases better, protection for
your data than you could in your own data center
• Understand how a cloud solution can, in many ways, be equated to outsourcing your data center
Moderator: Randy Perez, Director, Information Governance and
Management, Novartis, USA
Co-Moderator:
Bob Tollefsen, Consumer Safety Officer, FDA, USA
14.00 – 14.30Demystifying the Cloud
14.30 – 15.00Keys to Cloud Computing:
Confidentiality, Availability and
Integrity
15.00 – 15.30
Q&A
Session 2B
Sustaining Compliance Consistency throughout Your Supplier Networks
Over the past several years, the pharmaceutical industry has outsourced more and more of their
manufacturing, packaging, and distribution operations. In the past, the objective was “focus on the
core” and externalize the rest. We are now at a point where most operations are at least considered
for outsourcing and many of them fall into the outsourcing bucket. With this increased emphasis on
outsourcing, there is an increased need for effective monitoring of compliance parameters, product
risk and quality controls. This session will explore ways to ensure compliance of your providers and
ultimately protect the integrity of your product.
At the conclusion of this session, participants will be able to:
• Understand the compliance risks associated with supply networks
• Know what signs to look for in assessing these risks
• Identify ways to monitor and measure compliance of your suppliers
• Manage compliance with a higher level of confidence
ISPE.org/2012CGMP
Moderator:
Michael Arnold, R.Ph., Senior Director, Strategic
Partnerships, Pfizer Global Clinical Supplies, USA
14.00 – 14.30Managing CMO’s – Assuring
Compliance with Your Outsourced
Supply
14.30 – 15.00 Raw Material Controls – Upstream Supply Chain
15.00 – 15.30 Q&A
Education Sessions – Tuesday, 5 June Morning Sessions
Session 3A
Watching Your Process – Assuring Quality and Process Performance
Since the new Quality paradigm has begun in ICH with Q 8,9,10 and 11, emphasis has been placed
on management of the manufacturing process through its lifecycle.
This session will use case studies to review your process lifecycle from development through product
discontinuation. There will be a focus on the need to build quality in development, understand the
challenges in tech transfer, and fully comprehend the sources of variability or process drift. There
will also be a focus on establishing and maintaining your control strategy based on the current
understanding of the process and product.
At the conclusion of this session, participants will be able to:
• Focus on end-to-end lifecycle management of your product and process
• Understand how to establish and maintain a control strategy
• U
tilize some practical examples to demonstrate challenges in lifecycle management from tech
transfer to understanding and reducing sources of variation or process drift
• Maintain a state of control
Moderator:
Joe Famulare, Senior Director, Genentech, USA
11.00 – 11.40Establishing and Maintaining a
State of Control
11.40 – 12.15Understanding and Recognizing
Process Variability or Drift - Tools
that Can Identify and Control Your
Process
12.15 – 12.30 Q&A
Session 3B
Quality Risk Management: Using Risk Assessments in Manufacturing
It is well accepted by the industry and FDA that the use of sound scientific and quality risk management
approaches throughout the lifecycle are critical to establishing and maintaining a state of control. But
how does a company tangibly achieve this objective?
This session will use examples from industry and regulatory perspectives to show how the use of
risk assessment helps identify failure modes in an operation and promotes development of risk
mitigation approaches to control sources of variability. You will learn how good planning of facilities
and processes, strong monitoring systems and a quality assurance mindset throughout your operation
will prevent risks to product quality.
Discussion on the importance of taking advantage of contemporary technology and systems to
achieve better processes that provide both business and consumer benefits will also be presented.
At the conclusion of this session, participants will be able to:
• U
nderstand the advantages of using scientific and quality risk management approaches to promote
strong science-based decisions
• U
tilize modern technology and quality systems approaches to meet business and drug quality
objectives
• U
nderstand how lifecycle continual improvements are assured through good monitoring systems
and a strong quality assurance mindset
Moderator:
Michael Smedley, Deputy Director, Office of Manufacturing and Product Quality, OC, CDER, FDA, USA
11.00 – 11.40 Modernization and Its Role in
Quality Risk Management
11.40 – 12.15 Utilizing Quality Risk Management
in Risk Assessments
12.15 – 12.30 Q&A
ISPE.org/2012CGMP
Afternoon Sessions
Education Sessions – Tuesday, 5 June
Session 4A
Flexible Manufacturing
In today’s environment the market is demanding innovative products globally that are introduced
compliantly with rapid launches at competitive prices. In response to these market drivers the industry
has created new technologies to improve the speed at which manufacturing facilities can be delivered,
improve the output of existing operations, enhance reliability and reduce overall life cycle costing. This
session will use case studies to demonstrate the value of flexible manufacturing.
At the conclusion of this session, participants will be able to:
• Understand the benefits of using modular facilities in global delivery models
• Understand the cost benefits for flexible manufacturing operations through a demonstration
• Understand the best practices in delivery and operations of flexible manufacturing operations
Moderator: Jim Breen, Vice President Project Management, Johnson
& Johnson, USA
15.15 – 15.45 Disposable Manufacturing Equipment
15.45 – 16.30 Modular Manufacturing Units
16.30 – 17.00 Q&A
Session 4B
CAPA: Case Studies
The corrective action and preventive action (CAPA) program is an important part of a quality system.
CAPA requires commitment throughout an organization to surface significant issues, and prevent
conditions or practices that can ultimately lead to serious quality problems. Strong investigation
procedures and qualified staff are needed to identify root causes and define actions to address
emerging or existing problems. In some cases, inspections have found recurring drug quality issues
were not adequately remedied by a firm’s CAPA system. The value of an effective CAPA system will
be explored in this session and illustrative case studies from both industry and regulators will be
presented.
At the conclusion of this session, participants will be able to:
• Understand the role of the CAPA program in supporting maintenance of a state of control throughout
the lifecycle
• Understand the use of CAPA by the production and quality units
ISPE.org/2012CGMP
Moderator: Rick Friedman, Associate Director for Risk-Science
Intelligence and Prioritization, OMPQ, OC, CDER, FDA,
USA
15.15 – 15.45Perplexing Industry Case Studies
and Solutions
15.45 – 16.30Industry Sharing Experiences and
How it Can Benefit You Improvement Studies
16.30 – 17.00 Q&A
FEES
Baltimore Area Attractions
Baltimore Inner Harbor
Camden Yards
Gallery Mall
Fells Point
Hotel Information
For room reservations at the Conference venue, Renaissance Baltimore Harborplace Hotel, Baltimore, Maryland
USA., call tel: 1-800-HOTELS1 or +1-410-547-1200. When making your reservation by phone, mention ISPE
for a discounted rate of $195 single/double. This rate is good until 7 May 2012, or until the room block is full,
whichever comes first. Or you may make your reservation online at www.renaissanceharborplace.com and
use group code ISPISPA. 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 Renaissance as this enables ISPE to meet
contract requirements.
How to Register
ISPE and FDA
CGMP Conference Registration Fees
Member: $1,495
New Member: $1,734
Nonmember: $1,825
Government: $500
Online: Visit www.ISPE.org/2012CGMP
Via Fax: Complete the registration form online and fax it to: +1-813-264-2816
Via Mail:Complete the registration form online and mail it with payment to:
ISPE Headquarters • 600 N. Westshore Blvd., Suite 900
Tampa, Florida 33609 USA
Questions? C all 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 7 May.
Indicate your preferred morning and afternoon sessions
when registering. Once onsite, you’ll have the option to
attend any session.
Prices reflect Early Bird rates. Register before 7 May and
save up to $200. View ISPE website for more information.
ISPE – Membership Has its Benefits
Did you know that ISPE Members attend training programs and other events at discounted rates?
New Member registration fees include a one-year ISPE membership, a $239 value. Visit www.ISPE.org/Join for details on
Member benefits and special rates for Young Professionals, Students, Regulators and persons from countries with Emerging Economies.
ISPE EXCLUSIVE TRAINING 6 –7 June
Extend your stay to attend Classroom Training!
Before you complete your reservation, make sure you add Training to your agenda. ISPE
is offering two training courses. Extend your stay to attend one of these valuable training
courses specific to your career.*
Process Validation in Biotechnology Manufacturing (T32)
08.30 – 17.00
Instructor: Mark Witcher, PhD, Process Consultant, IPS
Level: Advanced
ISPE CEUs: 1.5
This course is designed to provide a clear understanding of the regulatory, scientific and engineering tools required
to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required
to validate biopharmaceutical processes. Topics include:
•
•
•
•
•
Develop and execute validation master plans and validation protocols
Understand and use FDA’s current process validation guidelines
Successfully run conformance lots for process qualification
Define key validation activities for biopharmaceutical process development and manufacturing
A
pply strategies and fundamental approaches for process validation of upstream and downstream processes for
clinical and commercial manufacturing
• Discuss validation documentation requirements
Turning QbD into a Practical Reality (T43) New Course and Guide
08.30 – 17.00
Instructor: Bruce Davis, Consultant, QbD, Process Engineering Validation
Level: Fundamental
ISPE CEUs: 1.3
This interactive training course utilizes the ISPE PQLI Guide Series: Part 1 - Product Realization using Quality by
Design, Concepts and Principles and Part 2 - Product Realization using Quality by Design, Illustrative Example as
the basis for explaining and providing examples of how products and processes can be developed, using QbD with
special emphasis on the considerations for implementing these processes in manufacturing.
Through group exercises, the course will delve into implementation and operation of an effective and efficient
control strategy in manufacturing which is a key element of process performance and product quality monitoring
and continual improvement
Note: This course will not cover the regulatory submission process or detailed engineering designs.
*Training Courses are not associated with the CGMP Conference. Must register separately.
Certified Pharmaceutical
Industry Professional™ (CPIP™)
Information Workshop
Tuesday, 5 June
This complimentary one-hour workshop
provides an overview of the CPIP™ Certification
Program, a pharmaceutical industry-focused,
international competency-based credential
made available through the ISPE Professional
Certification Commission.
Topics include: CPIP™ introduction, eligibility
criteria, overview of the application, examination
and re-certification processes, and information
on CPIP™ Study Groups.
Save
on Training!
ISPE Training Fees
Prices reflect Early Bird rates.
Register before 7 May and save up to $200.
Process Validation (T32)
Member...................... $1,610
New Member............... $1,849
Nonmember................ $1,945
Government................. $ 805
Turning QbD into a Practical Reality (T43)
Member...................... $1,710
New Member............... $1,949
Nonmember................ $2,050
Government ................ $ 855
New Member registration fees include
one-year ISPE membership. A $239 Value.
Early Bird rates are good until 7 May.
Check the website for more details.
ISPE PINNACLE PROGRAMME
2012 Global Sponsor
HOST SPONSOR
www.ISPE.org/2012BaltimoreTraining
NON-PROFIT ORG.
U.S. POSTAGE
PAID
600 N. Westshore Blvd., Suite 900
T a m p a , F l o r i d a 3 3 6 0 9 , USA
ISPE and FDA present
TAMPA, FL
PERMIT NO. 2661
Redefining the C in CGMP
“
”
Creating, Implementing and Sustaining a Culture of Compliance
4 – 5 June 2012
Baltimore, Maryland USA
Renaissance Baltimore Harborplace Hotel
ISPE.org/2012CGMP