Attend CPT's Powerful Two-Day Conference . . .

FDA's Quality Systems Approach

and Six Sigma for
Pharmaceuticals Main Conference · March 30-31, 2004
Pre-Conference Workshops · March 29, 2004
Crowne Plaza Hotel · Philadelphia, PA
No other event on the market can arm you with as many end-user
perspectives on how to:
• Benefit from Six Sigma in a pharmaceutical manufacturing environment
• Develop an audit program to meet FDA's systems-based approach
• Implement an effective internal audit program
• Review the evolution of QSIT from medical devices to pharmaceuticals
• Build a culture of compliance
• Gain practical knowledge on how to utilize risk management tools: FMEA and HAACP
• Integrate lean principles in the manufacturing of sterile pharmaceuticals
• Assess Part 11 compliance
• Develop and implement a systems-based inspection plan
• Improve quality and reduce costs in a highly competitive marketplace

SPECIAL THANKS TO:

FEATURED SPEAKERS INCLUDE: Pre-Conference
Joseph Fortunato Larry Price
Senior Director, Global Standards MBA, CQ Manager, Workshops
and Computer Compliance CQA, CQA-HACCP
COVANCE Associate Director, Monday, March 29,2004
DC Quality Programs
Nigel P. Holcombe Distribution Operations A. MASTER CLASS
Director, QA Compliance and WYETH PHARMECUTICALS Developing and
Certification Implementing a
ASTRAZENECA John O'Neill Systems-Based
Manager QC/Stability Operations Inspection Plan
Scott L. Grossman
Director, Regulatory Affairs
SANOFI-SYNTHELABO
RESEARCH B. How to Manage
MITSUBISHI PHARMA
AMERICA INC. Process Deviations
RECOMMENDED Kenneth J. O'Connor and Failure
PROFESSIONAL Senior Validation Engineer
ORGANIZATION:
Penelope Przekop Investigations Utilizing
Associate Director, Quality BAUSCH & LOMB a Systems Based
PRESENTED BY: Management Approach
JOHNSON & JOHNSON Jennifer Marie Zuzik-Sower
CPT John B. Wilmoth
Quality/Performance
Improvement Specialist
C. Change Management:
Center for Pharmaceutical Training
Production Project Manager,
A Step-by-Step Guide
A DIVISION OF: Six Sigma Black Belt
Medical Technology on How to Help Change
ROCKINGHAM MEMORIAL Efforts Succeed
ALCON LABORATORIES HOSPITAL
To Register Call 800-8
882-8
8684 • Email info@iqpc.com • Or Visit www.cptpharma.org
Who Will Attend:
At FDA's Quality Systems Approach and Six Sigma
for Pharmaceuticals, you will have the unique
opportunity to interact and network with
professionals in the Pharmaceutical and
Biotechnology industries:
✓ Quality Assurance
✓ Quality Control
✓ Quality Management
✓ Quality Engineering
✓ Operational/Process Excellence
✓ Regulatory Affairs
✓ Compliance
✓ Auditing
HERE’S JUST A SAMPLE OF
COMPANIES THAT HAVE ATTENDED
OUR PAST PROGRAMS:
3M
Abbott Laboratories
Alkermes
Allergan
Altana
Alza Corporation
Amgen
Amylin Pharmaceuticals, Inc.
AstraZeneca
Aventis
AVID Bio Services
BanzigerBanks
Baxter Healthcare
Bayer Corp.
Beckman Coulter, Inc.
Berlex Laboratories
Biogen
Biopure
Boehringer Ingelheim
Bristol-Myers Squibb
Cell Therapeutics
Centocor
Cephalon, Inc.
Charles River Laboratories
Chesapeake Biological
Laboratories
Cleveland Clinic
Foundation
Columbia University
Copernicus
Dey Labs
Durameo Pharmaceuticals
Eisai
Eli Lilly and Company
Ethicon
Forest Laboratories
Faulding Puerto Rico, Inc.
Fujisawa
Genentech
Genetics Institute
Genzyme
Gilead Sciences
Glaxosmithkline
Hoffmann-La Roche
IDEC Pharmaceuticals
ICN Pharmaceuticals
Immunex
2 To Register Call 800-8
CONFERENCE AT A GLANCE
PRE-CONFERENCE WORKSHIPS - MONDAY, MARCH 29, 2004
A. 8:00AM-1:00PM B. 1:30pm-4:30pm C. 5:00PM-8:00pm
MASTER CLASS Developing How to Manage Process Change Management: A
and Implementing a Deviations and Failure Step-by-Step Guide on How
Systems-Based Investigations Utilizing a to Help Change Efforts
Inspection Plan Systems Based Approach Succeed
DAY ONE - TUESDAY MARCH 30, 2004
7:45 Continental Breakfast and Registration
8:15 Chairperson's Welcome and Opening Remarks
8:30 Current State of the Industry: Pharmaceutical cGMPs for the 21st Century:
A Risk-Based Approach
9:15 Developing An Audit Program to Meet FDA's Systems-Based Approach
10:15 Morning Refreshment Break
10:45 Implementing Process Excellence Techniques and Strategies in the
Pharmaceutical Industry
11:30 How to Utilize ISO 9000:2000 to Establish Continuous Improvement to
Your Processes
12:15 Lunch
1:45 Managing the Globalization of the Quality Systems Approach in Your
Organization
2:30 Assessing Part 11 Compliance- An Auditor's Perspective
3:15 Afternoon Refreshment Break
3:45 The Evolution of QSIT from Medical Device to Pharmaceuticals
Indiana University 4:30 Building a Culture of Compliance
Janssen Pharmaceuticals 5:15 Conclusion of Day One General Session
Johnson & Johnson DAY TWO - WEDNESDAY - MARCH 31, 2004
Joint Programs Office of
Bio 8:00 Continental Breakfast
Defense 8:30 Chairperson's Day Two Opening Remarks
La Jolla Pharmaceuticals 8:45 Implementing a Quality Systems Approach Within Your Organization
Ligand Pharmaceuticals 9:30 Utilizing Risk Management Tools: Failure Mode Effect Analysis (FMEA)
Merck and HAACP
National Cancer Institute
10:15 Morning Refreshment Break
National Institute of Health
Neutrogena 10:45 Creating an Organizational Framework using Quality Management Concepts:
Novartis Black Belt not Required
Novo Nordisk 11:30 Integration of Lean Principles in the Manufacture of Sterile Pharmaceuticals
Organon 12:15 Lunch
Ortho-McNeil 1:45 Continuous Improvement Initiatives: Improving Quality and Reducing Costs in a
Otsuka Highly Competitive Marketplace
Paddock Laboratories 2:15 The Fundamentals of Six Sigma
Parexel
Perkin Elmer Instruments
3:00 Afternoon Refreshment Break
Pfizer 3:30 Application of Six Sigma Methodology to Pharmaceutical Processes
Pharmacia 4:15 How Six Sigma Benefits a Pharmaceutical Manufacturing Environment
Procter and Gamble 5:00 Conclusion of Conference
Purdue Frederick
Purdue Pharma
Quintiles
If You Attend Only One Conference This Year, Make Sure
Raytheon It's FDA's Quality Systems Approach . . . Here’s why:
Roche Diagnostics
At FDA’s Quality System Approach, Here are Just a Few of the Questions that Will be Answered. . .
Sankyo
Sanofi-Synthelabo • What is Six Sigma? • How does Six Sigma relate to quality
Schering AG systems?
• How can Six Sigma be applied to the
Schering Plough
Schwarz Pharma
pharmaceutical industry? • What is QSIT?
Serono • How can ISO 9000:2000 be used to • How does QSIT differ from FDA's
Solvay improve productivity? Systems-Based Inspections?
Sugen
Takeda • What are the key areas of FDA's • What are the organizational issues
Teva Pharmaceuticals systems based inspections? withimplementing a quality system?
Thera Cardia
• What are the challenges in building an • How can Six Sigma and Lean be
Viropharma
Vista Bialogic Corporation
internal audit program? applied in the laboratory?
Vivometrics • What is necessary to manage audits • What is Failure Mode and Effects
West Pharmaceuticals using quality systems? Analysis (FMEA)?
Wyeth Ayerst
Yamanouchi
• How can risk be communicated in an • How can FMEA be applied to the
Pharmaceuticals organization? pharmaceutical industry?
882-8
8684 • Email info@iqpc.com • Or Visit www.cptpharma.org
PRE-CONFERENCE WORKSHOPS - MONDAY, MARCH 29, 2004
A Note From CPT About Workshops…
CPT workshops are short, interactive training courses attached to our conferences to give our participants real world, practical experience through exercises, discussions and
case study analyses. CPT workshops are specially designed to optimize sharing of best practices and practice tips through an in-depth look at niche topics. These vital sessions
are designed to give you an "A to Z" roadmap approach to tackling common challenges.
A MASTER CLASS 8:00 AM - 1:00 PM
Developing and Implementing a Systems-Based Inspection Plan
FDA has implemented a Systems-Based approach to GMP 5-HOUR
inspections. Activities found in drug firms are organized into six INTERACTIVE
systems that are sets of operations and related activities. Control LEARNING
of all systems helps to ensure the firm will produce drugs that are WORKSHOP
safe, have the identity and strength, and meet the quality and
purity characteristics as intended.
This program establishes a systems approach to provide for a uniform level of
CGMP assessment, which is used in determining the overall acceptability of the firm.
The measure of success comes from being prepared. Pharmaceutical companies
need to take a proactive approach in evaluating their systems and assessing whether
they are in a "state of control". Attending this workshop will help to ensure that your
firm will meet FDA's expectations. Key topics include:
• Learning how FDA conducts systems-based inspections
• An in-depth review of the six systems
• Tips on preparing for a systems-based inspection
• Assessing whether you are in compliance
• Discussion of system related inspection findings
B AFTERNOON WORKSHOP
How to Manage Process Deviations and Failure
Investigations Utilizing a Systems Based Approach
Process deviations and their impact on daily operations can be monumental.
Handling these deviations in a compliant manner is paramount to successful release of
product. This workshop is designed to give the attendee an overview of the processes
associated with process deviations, their impact on change control, approaching the
deviation via a systemic approach and conducting an investigation. The workshop
will include the following key topics:
• Assigning and delegating roles and responsibilities
– Detailing your investigative process
– Identifying corrective action strategies
• Summarizing the investigational process in the proper documentation format
– FDA defined systems
– Process deviation "system"
• Change control "systems"
– What requires an investigation?
– SOPs for different departments
– Notification of a potential investigation
C EVENING WORKSHOP
Change Management: A Step-by-Step Guide on How to
Help Change Efforts Succeed
Fortune 1000 companies are facing a multitude of forces driving the need for
change, quality and improvement. It’s a familiar list: global competition, accelerating
product lifecycles, new technology, regulatory pressures, margin squeeze and so on. Yet
against this backdrop, virtually all quality professionals report feeling that their insights
and experience are not being fully used, that they know more than is being utilized, that
they can make even greater contributions. This appears to be so even in the most
successful initiatives, and even as people report feeling stressed and overworked. When
asked why, most attributions about cause point to inadequacies in the user system,
securing critical resources, getting the user community committed, navigating conflicting
priorities, unrealistic demands, or problems in the relationships between groups. Putting
these themes together, it appears that quality is not instant pudding. There’s more to it
than adding methodology or resources. Sometimes, even the well-intentioned efforts of
senior management can’t “shout and hope” change into place.
This workshop explores the domain and principles of helping change efforts succeed.
Part of our time will look at best practices - the things you can adopt and adapt from out
there in industry - what works - in terms of change management. Part of the workshop
will invite you to consider the aspects of change management that happen from the
inside out - and learning to coach others constructively. This interactive workshop takes a
holistic and balanced view - and provides you with principles, tools and practice in being
more effective at helping change succeed. Key topics include:
• Changing practices and processes
• Changing mindsets and attitudes
• Changing relationships
About Your Workshop Leaders:
Cynthia L. Palka, M.S., RAC, CEC, is President of Future Map, Inc., a professional
coaching and consulting firm that assist individuals and companies in the
pharmaceutical and biotech industries with their change management efforts. Ms.
3 To Register Call 800-8
882-8
8684 • Email info@iqpc.com • Or Visit www.cptpharma.org
About Your Workshop Leader:
Phyllis Lambridis is President of Framework Quality Systems, LLC, a consulting
firm that specializes in building the foundation for FDA compliance. She has 20 years
of industry experience in quality control, quality assurance, regulatory affairs and
compliance. Her expertise lies in providing guidance on preparing for and
responding to FDA inspections, assisting with investigation report and SOP writing and
building quality systems to ensure GMP compliance.
Ms. Lambridis was Vice President, Corporate Compliance for Halsey Drug
Company, Inc., where she was responsible for all Quality Assurance, Quality Control,
Regulatory Affairs and Validation activities. Prior to joining Halsey Ms. Lambridis was
Director of Corporate Policies, Standards & Systems at Watson Pharmaceuticals. Ms.
Lambridis was employed at Barr Laboratories, Inc. from 1987 to 1998 where she held
various positions of increasing responsibility in both Regulatory and Quality. She was
actively involved in the court proceedings in United States vs. Barr Laboratories, Inc.
and was later appointed as FDA Liaison and Director of Regulatory Compliance.
Ms. Lambridis received her bachelor's degree in Microbiology from Rutgers
University and her Master's degree in Bacteriology from Wagner College.
1:30 PM - 4:30 PM
• Review and verification of the situation requiring an investigation
• Evaluation of the immediate area or process for problems
– Expansion of the investigation
– Who does the investigation?
• Writing the investigation - what the investigation should contain
– CAPA
– Time frames
– Approval
– Impact and further notification
About Your Workshop Leader:
As the Vice President of Compliance Insight, Inc., Troy Fugate will work with
companies regionally and worldwide in the pharmaceutical and biotechnology
industries in the fields of Compliance and Quality Assurance. His consulting realm
includes parenteral, tablet, capsule, oral liquid and API regulation compliance. Troy's
primary strengths are Quality Assurance activities with emphasis in quality systems,
risk assessment and systemic audits.
5:00 PM - 8:00 PM
Palka has been working in the life sciences arena since 1992. She was employed at
Wyeth Research as a Medicinal Chemist, and has held positions as an executive
recruiter in the life sciences practices of large and boutique search firms. Ms. Palka
formed her own company in 2000. Ms. Palka is a Certified Empowerment Coach
(CEC) by the Institute of Professional Empowerment Coaching (IPEC) and a member
of the International Coach Federation (ICF). She holds a BS in Chemistry and MS in
Biochemistry and is a Regulatory Affairs Certified (RAC) professional.
Bill Dunnington is Managing Director and Founder of Performance
Development Strategies, LLC, a management consultancy based in Virginia. He is a
seasoned general management executive with broad experience in the Fortune 500,
who helps executives:
• Understand the business situation, especially customer needs, expectations and
priorities.
• Assess internal processes, competencies, culture and capabilities in this context.
• Design and lead change strategies that bring these together to accelerate
tangible gains.
With over twenty years experience, the solutions he brings reflect an appropriate
mix of tools or disciplines - customer value management, strategy formulation,
organization design, competency and culture development, marketing and
communications, technology integration, leadership development, action learning,
process quality and change management, measurement analytics and program
management. Mr. Dunnington is a versatile facilitator and process consultant by
experience and a practical strategist by instinct. He has had a rich variety of roles and
experiences while leading quality improvement inside two Fortune 100 firms, and
consulting with practitioners who are leading Baldrige, Six Sigma or ISO initiatives. He
holds a BA in Organization Psychology and a Master’s in IT Strategy and
Management.

DAY ONE:
TUESDAY, MARCH 30, 2004
7:45 Continental Breakfast and Registration
8:15 Chairperson's Welcome and
Opening Remarks
Nigel P. Holcombe
Director, QA Compliance and Certification
ASTRAZENECA
8:30 Current State of the Industry: Pharmaceutical
cGMPs for the 21st Century: A Risk-Based
Approach
On August 21, 2002, the Agency launched a two-year initiative,
Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach. This
objective of this initiative is to encourage the early adoption of new
technological advances by the pharmaceutical industry, facilitate industry
application of modern quality management techniques, including
implementation of quality systems approaches, encourage implementation
of risk-based approaches that focus both industry and Agency attention on
critical areas, ensure that regulatory review and inspection policies are
based on state-of-the-art pharmaceutical science, and enhance the
consistency and coordination of FDA's drug quality regulatory programs.
This session will discuss the following key topics:
• Why FDA launched this initiative
• FDA's expectations
• Update on the progress of this initiative
• How industry and FDA need to work together using science-based
policies and procedures to facilitate innovation within the existing
regulatory framework
• The steps FDA has taken to streamline and improve its internal
processes
Phyllis Lambridis
President
FRAMEWORK QUALITY SYSTEMS, LLC.
9:15 Developing An Audit Program to Meet FDA's
Systems-Based Approach
Internal audits are a proactive approach to ensuring
FDA compliance. This case study addresses the CASE
corporate demands of building an audit program, STUDY
effective strategies and the changes in approach
required for complying to FDA's new systems-based
approach. Key topics include:
• Understanding the key areas of FDA's system-based inspections
• Defining responsibilities for your audit program
• Administrative and staffing issues
• Differences between the European approach to auditing and FDA
Nigel P. Holcombe
Director, QA Compliance and Certification
ASTRAZENECA
10:15 Morning Refreshment Break
10:45 Implementing Process Excellence Techniques
and Strategies in the Pharmaceutical Industry
This session will highlight the experiences from quality improvement
projects within the pharmaceutical industry. Delegates will learn how to
identify best practices that can immediately be applied throughout their
organization. The session will also give a quick overview of theories such as,
'Quality Systems are not processes' to application tolls such as, 'meeting free
Wednesdays'. Real life results from quality system improvement programs
will also be presented. The session will also cover such topics as:
• Program Approaches - What can we do to revise systems in operating
plants? Is Six Sigma a new or old approach?
• Quality Systems - What are they, and how do they differ
from processes?
• Success Factors - How much 'top management support' do you need?
4 To Register Call 800-8
882-8
8684 • Email info@iqpc.com • Or Visit www.cptpharma.org
Is this a strategic project?
• Communication - Does reporting status overwhelm our ability to
gather relevant data? How much project control is enough?
Tim Oswald
Project Manager
QUANTIC GROUP
11:30 How to Utilize ISO 9000:2000 to Establish
Continuous Improvement to Your Processes
The process approach is used by both the ISO 9000:2000 standard and
FDA's quality system approach regulation. Key elements of both are
continual improvement. Establishing a thorough understanding of how to
implement them is critical to success. This session will discuss the following
key topics:
• What the ISO 9000:2000 standard is
• The relationship between the ISO 9000:2000 standard and FDA's
quality systems approach
• How to use the ISO 9000:2000 standard and FDA's quality system
approach regulation to improve your processes
• Why the ISO 9000:2000 standard is important to the pharmaceutical
industry
• How to make continual improvements cost-effective
Linda Bankoski
President
QUALITY LEADERSHIP ASSOCIATES
12:15 Luncheon for Speakers and Attendees
1:45 Managing the Globalization of the Quality
Systems Approach in Your Organization
Pharmaceutical and biotech companies have affiliates or parent
companies in international countries. As a result, these companies need to
build internal audit programs with a global perspective in mind. If your
company operates internationally, your quality systems will be held to a
global standard and harmonization will take on a specific corporate
application. This session will address the many facets involved with
globalization of your systems. Included are:
• International standards; where they are similar and how they differ
• Designing quality unit structure to fit a multi-national corporation
• Defining the standards and requirements for Japan, EU and the US
• Building information systems to aid the harmonization effort
• Utilizing International SOPs to guarantee uniformity
• Implementing a uniform procedure and standard based on product
type and location
• Conducting audits to ensure best practices
• Overcoming the language barrier through design, skill and spirit
John O'Neill
Manager QC/Stability Operations
SANOFI-SYNTHELABO RESEARCH
2:30 Assessing Part 11 Compliance:
An Auditor's Perspective
This real-world implementation case study will highlight the following:
• Assessing part 11 compliance
• Overview of the new guidelines
• Auditing internal systems
• How the FDA guidelines are affecting auditing
• Identifying gaps in complying with regulation and FDA guidelines
Joseph Fortunato
Senior Director, Global Standards and Computer Compliance
COVANCE
3:15 Afternoon Refreshment Break
3:45 The Evolution of QSIT from Medical
Device to Pharmaceuticals
As the FDA continues to perform system-based inspections at
pharmaceutical companies much can be learned about the inspection
program for medical devices. Called QSIT, the 1999 medical device
inspection technique was a radical change in FDA inspection approaches.
This presentation will discuss the QSIT program, its history, benefits and
relationship with traditional FDA inspections. Pharmaceutical systems and
processes will also be discussed. As the primary leader of FDA's QSIT
program Tim Wells will discuss:
• QSIT and quality systems with a unique FDA perspective
• How does QSIT currently affect medical device vs. Pharmaceutical
• Implementing appropriate techniques and strategies to align yourself
with QSIT principles
Tim Wells*
President
QUALITY HUB
*Tim is a 24-year veteran of FDA and co-authored "FDA Guide to the
Inspection of Quality Systems (QSIT) Handbook".
4:30 Building a Culture of Compliance
Effective strategies used by FDA and industry for the management of
risk include:
• Focus on high risk/high economic impact situations
• Focus on risk independent of level of actual risk
• Focus on high profile cases to create a psychological deterrent
• Collaborative risk management
This presentation will describe the above four risk management strategies
and cite specific examples of their use. A fifth industry strategy for risk
management is to build a culture of compliance. Although the US Inspector
General, the US Sentencing Commission, and corporate management have
discussed "culture of compliance", the concept remains vague. "Culture of
compliance" is a type of organizational culture. Definitions and attributes of
a culture of compliance will be presented along with a description of
positive outcomes associated with establishing a culture of compliance.
Steps to build a culture of compliance will be described. This presentation
will show that consideration of aspects of organizational culture is beneficial
for the establishment of an effective corporate compliance program, and
that building a "culture of compliance" can be considered as an additional
strategy for organizational risk management.
Scott L. Grossman
Director, Regulatory Affairs
MITSUBISHI PHARMA AMERICA INC.
5:15 Conclusion of Day One General Session
DAY TWO:
WEDNESDAY, MARCH 31, 2004
8:00 Continental Breakfast
8:30 Chairperson's Welcome and
Opening Remarks
Nigel P. Holcombe
Director, QA Compliance and Certification
ASTRAZENECA
8:45 Implementing a Quality Systems Approach
Within Your Organization
This session identifies "Critical Success Factors" necessary for a company
to realize implementation of a suitable and effective quality system.
Emphasis is placed upon developing a strategy that is based upon
reasonable business systems and processes that are suitable and effective,
while meeting applicable governing requirements. Learn key elements to
performing an organizational assessment that takes into consideration
different situational factors that can have an affect on a company's
compliance status. Attendees will also benefit from an in depth discussion
concerning what it take to comprehend a "Corporate Culture" and to
manage the change process. Key topics include:
• How to prepare for the implementation process - what are the critical
steps you must take?
• How to obtain buy-in and increase communication with your
management?
• Is the ROI measurable? How can you assess if it is working?
• How to effectively gain company intelligence from conducting
management interviews?
• How to compare and contrast a systems-based approach with
traditional approaches?
• What situational factors and contingencies need to be considered?
5 To Register Call 800-8
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8684 • Email info@iqpc.com • Or Visit www.cptpharma.org
• What are the five major activities required to manage the
change process?
J. Glenn George
Founder and President
QRC ASSOCIATES, LLC
9:30 Utilizing Risk Management Tools: Failure Mode
Effect Analysis (FMEA) and HAACP
FMEA and HAACP represent two major risk management tools most
frequently utilized by the medical device industry. These tools are now
applied to the pharmaceutical industry. Companies that manufacture
devices and drugs have a fundamental understanding of risk analysis tolls
like FEMA and HAACP. However, the question is: what does the FDA
mean when they talk about risk management and how does that differ from
risk analysis? This session will cover the following:
• Risk management vs. risk analysis
• Applying risk based tools for validation planning and ongoing
• Determination of operational compliance
Larry Price
MBA, CQ Mgr, CQA, CQA-HACCP
Associate Director, DC Quality Programs
Distribution Operations
WYETH PHARMECUTICALS
10:15 Morning Refreshment Break
10:45 Creating an Organizational Framework using
Quality Management Concepts: Black Belt not
Required
Have you heard the strong message that in order to create the cultural
change needed for full implementation of a Quality Management Approach,
high-level support is essential? Are you interested in implementing Six
Sigma, ISO 9000:2000, and/or Malcolm Baldrige concepts but don't have a
black belt, don't know how to get one, can't get one, or have other
priorities? Good news! There are ways in which Middle Management can
incorporate key Quality Management concepts today. By understanding
and using these concepts, you can begin to change the culture of your
organization from the inside out. You don't have to wait until your CEO
declares that SIX SIGMA is the answer, bringing in consultants or starting a
Black Belt training program. This type of high-level support would be
fantastic, but don't wait. By implementing the key concepts listed below
and others, you can begin making a difference in your organization today:
• Process Focus/Documentation
• Customer Focus
• Data Driven Management
• Limitless Boundary Collaboration
Penelope Przekop
Associate Director, Quality Management
JOHNSON & JOHNSON
11:30 Integration of Lean Principles in the
Manufacture of Sterile Pharmaceuticals
For several years, JIT and Lean management techniques have been used
effectively in the manufacturing of medical devices. The results have been
measured in cost savings and more importantly, in the improvement of
product quality by creating an environment that fosters compliance.
Recently, pharmaceutical companies have become interested in programs
such as six sigma to: improve quality, promote teamwork throughout the
organization, improve service levels and reduce costs. At the same time,
the use of Lean principles is under consideration to streamline all facets of
the operation. This session will discuss the elements of Lean management
by defining techniques such as 5S, Value Stream Mapping and Kanbans.
Two projects will be reviewed to demonstrate how techniques for product
sterilization and machine set-up were improved through the use of Lean
principles.
Kenneth J. O'Connor
Senior Validation Engineer
BAUSCH & LOMB
12:15 Luncheon for Speakers and Attendees
1:45 Continuous Improvement Initiatives:
Improving Quality and Reducing Costs
in a Highly Competitive Marketplace
This presentation addresses how to set up a Continuous Improvement
Initiative in your organization and greatly reduce manufacturing costs while
maintaining excellent product quality. This concept is key in today's highly
competitive marketplace. Learn how to get senior management buy-in and
participation from employees at all levels of the organization as well as the
importance of a rewards and recognition program. Key topics include:
• Strategies for implementation
• Ways to stimulate employee involvement
• Keys for your purchasing group to reduce manufacturing costs
John B. Wilmoth
Production Project Manager, Medical Technology
ALCONE LABORATORIES
2:30 The Fundamentals of Six Sigma
This presentation is designed to define and explain the fundamentals of
Six Sigma methodology. The session will also look at the details of: "Sigma",
"Six Sigma", and the "Six Sigma methodology". The speaker will present the
Six Sigma methodology steps, tools used within each step, and how the
steps move us to process improvement. There will also be a section that will
encourage you to question your own processes, suppliers, and customers
along the "Six Sigma Mindset" and put you in the "data thinking" mode. Key
topics include:
• Realistic expectations for Six Sigma deployment
• Vision/key strategies
• Measurement
• Developing and applying a Six Sigma strategy
• Project identification and selection
• Training and certification
Jennifer Marie Zuzik-Sower
Quality/Performance Improvement Specialist
Six Sigma Black Belt
ROCKINGHAM MEMORIAL HOSPITAL
3:15 Afternoon Refreshment Break
3:45 Application of Six Sigma Methodology
to Pharmaceutical Processes:
This case study addresses the successes Wyeth Pharmaceutical has had
in applying Six Sigma tools to resolve and improve processes within their
organization. The experience of developing a
strategy to implement and deploy Six Sigma; how it
can be linked to the organization goals & objectives CASE
and the importance of management involved. The
presentation will share the most common obstacles
STUDY
encountered and how to orchestrate a winning
scheme. Establishing the logistic of selecting the right people and the right
projects. The importance of assembling the right project teams to ensure
project success. Key topics include:
• Reduce variation and obtain bottom line benefits by addressing
particular elements focusing on value added activities
• Effort initiatives to institutionalize Six Sigma systematic approach:
How to make it part of operations
• Partnering with our customers in fulfilling their wants and needs,
achieving sustainable results
• Examples on how Six Sigma techniques can be applied to sterile
manufacturing
• How Wyeth addresses situations and opportunities and effectively
measure results utilizing key process metrics
• Turning data into the most valuable element when identifying areas of
improvement
Iris Cordero
Director, Business Process Management and Process Excellence
WYETH AYERST LEDERLE
Mark A. Deutsch
Manager, Global Training & CI
WYETH PHARMACEUTICALS
6 To Register Call 800-8
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8684 • Email info@iqpc.com • Or Visit www.cptpharma.org
4:30 How Six Sigma Benefits a Pharmaceutical
Manufacturing Environment
As complex economic, social and business issues continue to place
pressure on the Pharmaceutical industry, it is evident that a quantum change
is required across the supply chain across many areas -- including quality
and compliance; capability to manufacture and work agilely across a
network of partners. This presentation will provide manufacturing, supply
chain and quality professionals with a view of where the industry is heading
over the next three to five years. Delving into the key areas Pharmaceutical
manufacturing leaders should be concentrating their efforts on, this talk will,
in particular, focus on two drivers that are causing pressure on the industry:
therapeutic product evolution and a new regulatory compliance agenda.
Key topics include:
• There will be a new focus on the individual that will require new,
highly specific patient data and highly specific manufacturing facilities
• Companies will partner with MCO's and/or physicians for patient data
• Integration will be imperative between customer facing technology
and the supply chain
• Factories will be product specific - traditional, mass customized and
targeted products
• Process compliance will be measured and driven to new levels of
performance
• Can six sigma principles effectively reduce cycle time for the pilot
plant and drug manufacturing process? How does the reduced cycle
time translate into dollars for company savings
• How to implement Design of Experiments into your robustness tests
• How would you implement Six Sigma into a sterile manufacturing
environment?
Jim Prendergast
Lead Partner, Pharmaceutical Supply Chain Management,
IBM GLOBAL SERVICES
5:15 Conclusion of Conference
About the Event Organizer . . .
The Center for Pharmaceutical Training (CPT)
is the world's leading provider of training for
pharmaceutical professionals. Focusing on
training for a variety of pharmaceutical
functions, including drug discovery, good
CPT
Center for Pharmaceutical Training
laboratory practice (GLP),good manufacturing
practice (GMP), good clinical practice (GCP), quality control (QC),
quality assurance (QA), validation, 21 CFR Part 11 and other regulatory
issues, and more. At the Center for Pharmaceutical Training, we know
how essential GXP compliance is to keeping your projects on time and
on budget. That's why we're here to provide you with the tools you need
to meet your goals. Whether you're in drug development, electronic data
capture, microbiological monitoring, packaging, metrology, or computer
systems and data management, the Center for Pharmaceutical Training
can help. Visit www.cptpharma.org.
CPT Conferences Available on CD Rom!
Can't attend the conference? While there's no substitute for being
onsite, you can now benefit from all of the presentations, exhibitor
information and other key strategies and insights passed along at the
event by purchasing a specially prepared FDA's Quality Systems
Approach and Six Sigma for Pharmaceutical CD Rom.
The CD Rom is a permanent reminder of the conference and
contains all of the detailed PowerPoint presentations that were prepared
by the speaker faculty and presented at the event; a full color
conference brochure; detailed information
about the event sponsors and exhibitors along
with information about how your company can
get involved in future events; and upcoming
IQPC events! The cost of the CD Rom is only
$499 - a mere fraction of the registration price!
To reserve your CD Rom call IQPC's
Customer Service Department at
800-882-8684.
SPECIAL THANKS TO: PharmaVOICE is the executive forum that allows business
leaders to engage in a candid dialogue on the myriad
Inspection Monitor is the only challenges and trends impacting the life-sciences industry.
PharmaVOICE reaches more than 17,000 U.S.-based executives who influence
newsletter with the strategic information
business strategies and affect change. Published monthly, PharmaVOICE
you need about FDA inspections, including what FDA inspectors are really
provides readers with insightful and thought-provoking commentary in a multiple-
looking for, how companies are responding to 483 and EIR citations, which perspective format through its forums, topics, and articles that cover a range of
companies are targeted for enforcement proceedings and who's making issues from molecule through market. To Raise Your VOICE, contact
FOIA requests for FDA 483s and EIRs. feedback@pharmavoice.com. Website: www.pharmavoice.com
Validation Times is the monthly American Pharmaceutical Review is the leading review of business and
newsletter with weekly e-mail alerts that technology for the pharmaceutical industry throughout North
puts you in the shoes of FDA field America. Each issue offers American Pharmaceutical
inspectors and tells you how your competition fared in an audit. Review's 30,000 readers unbiased editorial on the following
topics: PAT, drug delivery, information technology, research &
Warning Letter Bulletin is the only development, analytical development and control, equipment and facility
service that summarizes all warning and manufacturing, regulatory affairs and outsourcing. For your FREE subscription,
untitled letters, categorized by YOUR INDUSTRY. Every two weeks you can please fill out our on-line form at www.americanpharmaceuticalreview.com
read summaries of all warning and untitled letters, learn what FDA found on Recommended Professional Organization
its inspections, and read company responses!
Don't miss the opportunity to join the only organization, The
Pharmaceutical Technology. Essential to the International Society of Six Sigma Professionals (ISSSP),
manufacturing process for over 27 years, Pharm committed to promoting the adoption, advancement and
Tech expertly covers all aspects of integration of Six Sigma in business. The ISSSP Community
pharmaceutical/biopharmaceutical manufacturing. supports this mission through advocacy and awareness efforts;
professional recognition and development; and by serving as an
From applied research to equipment to drug delivery to information
information and referral source. Become a Professional Member
technologies to contract services to biotech trends Pharm Tech meets the
of ISSSP for $150.00 (a 25% discount) by registering online at www.isssp.com
needs of 33,741 BPA Qualified subscribers with authoritative, technically and using the Discount Code: IQPCEVENTS
accurate editorial. www.pharmtech.com

SPONSORSHIP and EXHIBITION OPPORTUNITIES

For more detailed information on these opportunities please contact,
Matthew Singer at 212-885-2769 or email him at matthew.singer@iqpc.com.
REGISTER BY PHONE • FAX • MAIL • E-MAIL OR WEB SITE
☎ Call: 800-882-8684 or 973-812-5165 Payment Policy
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150 Clove Road CPT's Delegate Substitution, Cancellation and
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@ E-Mail: info@cptpharma.org You may substitute delegates at any time. For cancellations received in writing, you
will receive a 100% credit to be used for up to one year from the date of issuance.
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Options: February 13, 2004 February 13, 2004
CPT shall assume no liability whatsoever in the event this conference is cancelled,
PLATINUM PACKAGE: Save $200 rescheduled or postponed due to a fortuitous event, Act of God, unforeseen
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Master Class
include, but not be limited to: war, fire, labor, strike, extreme weather or other
Save $100 emergency.
Master Class, Please Add: $699*
$799* Please note that speakers and topics were confirmed at the time of publishing,
however, circumstances beyond the control of the organizers may necessitate
substitutions, alterations or cancellations of the speakers and/or topics. As such, CPT
Workshops, Please Add: Save $100 reserves the right to alter or modify the advertised speakers and/or topics if
$500 each* necessary. Any substitutions or alterations will be updated on our web page as soon
Choose ❏ B ❏C $400 each*
as possible.
Lodging Information: Sessions for the conference & workshops will be held at:
Save $100
Conference Only: $1,799 $1,899
CROWNE PLAZA • PHILADELPHIA CENTER CITY
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MAKING TRAVEL PLANS? For discounted flight reservations on most major
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contacts CPT Events Official Travel Planner, Candy Eardley
of Travel Forum toll-free at 1.877.852.4135 or locally at
973.942.0100. Candy can also be reached via email at
candy@travelforuminc.com.
© 2004 CPT/IQPC All Rights Reserved. The format, design, content and arrangement of this
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7 To Register Call 800-8

882-8
8684 • Email info@iqpc.com • Or Visit www.cptpharma.org
 REGISTRATION CARD
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*Please add 6% sales tax if your workplace is in Connecticut (CT). Event # 2049.02/SM/KF

Attend CPT's Powerful Two-Day Conference . . .

FDA's Quality Systems Approach

and Six Sigma for
Pharmaceuticals Main Conference · March 30-31, 2004
Pre-Conference Workshops · March 29, 2004
Crowne Plaza Hotel · Philadelphia, PA
No other event on the market can arm you with as many end-user per-
spectives on how to:
• Benefit from Six Sigma in a pharmaceutical manufacturing environment
• Develop an audit program to meet FDA's systems-based approach
PRESENTED BY:
• Implement an effective internal audit program
• Review the evolution of QSIT from medical devices to pharmaceuticals
CPT
Center for Pharmaceutical Training
• Build a culture of compliance
• Gain practical knowledge on how to utilize risk management tools: FMEA and HAACP
A DIVISION OF: • Integrate lean principles in the manufacturing of sterile pharmaceuticals
• Assess Part 11 compliance
• Develop and implement a systems-based inspection plan
• Improve quality and reduce costs in a highly competitive marketplace