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The Parenteral Drug Association presents the...
2014 PDA/FDA
Pharmaceutical Quality
System (ICH Q10)
Workshop on Quality
Risk Management
Using Q10 to Make Compliance
Synonymous with Quality Performance
November 3-5, 2014
BALTIMORE MARRIOTT WATERFRONT
BALTIMORE, MARYLAND
EXHIBITION: NOVEMBER 3-4
COURSE: NOVEMBER 6
www.pda.org/ICHQ10
THIS PRELIMINARY AGENDA IS CURRENT AS OF JULY 28, 2014
TAPE RECORDINGS ARE PROHIBITED AT ALL PDA CONFERENCES
HHS has not endorsed any solicitations for this meeting. All donations have been applied exclusively towards defraying the expenses
of non-Federal co-sponsors, not HHS. HHS is not asking for any funds in any capacity.
2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management
Connecting People, Science and Regulation®
Program Committee
A Message from the Co-Chairs
C0-Chairs:
Dear Colleagues:
Rick Friedman,
FDA
Anders Vinther, PhD,
Sanofi Pasteur
Ursula Busse, PhD, Novartis Group Quality
James Drennen III, PhD, Duquesne University
Brooke Higgins, FDA
GK Raju, PhD, Light Pharma Inc.
Emabelle Ramnarine, Genentech, Inc.
Robert Roy, IPS
Janeen Skutnik-Wilkinson, NSF-Health Sciences
Michael Smedley, FDA
Sharon Timmis, Pfizer, Inc.
Robert Woolfenden II, Amgen, Inc.
Leon Lewis, PDA
Wanda Neal, PDA
How well does your company manage risks? Does it detect small problems before they
become large ones? Are you a more reactive organization, or have you shifted to proactive
quality assurance through use of ICH Q10 enablers Quality Risk Management (QRM) and
Knowledge Management (KM)? In other words, have QRM and KM crossed the line from
theory to practice in your daily manufacturing and business activities?
The ICH Guideline entitled ICH Q10 Pharmaceutical Quality System (PQS) has helped structure
how we all work with quality systems across our industry and within our companies.
The regulatory requirements of the US and EU now explicitly require QRM, and stress the
important contributions of all organizational components (QA, production, development)
and managers (from supervisors to top leadership) in assuring that high quality products
are produced each day, emerging problems are addressed, and systems and processes are
adapted in response to experience gained in the lifecycle.
As part of the ongoing ICH Q10 implementation series, FDA and PDA have jointly developed a
very comprehensive program to teach QRM tools and to facilitate better QRM integration into
pharmaceutical operations. The 2014 PDA/FDA ICH Q10 Workshop on Quality Risk Management
will address use of QRM in the supply chain, process design, addressing failures, process
control, CAPA, scale-up, analytical methods, management oversight, and several other areas.
Case studies from both the pharmaceutical industry and other industries will be presented.
US and EU regulatory perspectives will be discussed. In addition, companies will discuss
how they have successfully implemented QRM and KM to improve process consistency
and product quality, and business predictability. This will include the key role played by
Operational Excellence and Six Sigma programs at these companies.
While many companies have integrated efficient QRM processes into their PQS, there are still
many opportunities to improve on current inspectional findings, process control problems,
defects, and drug shortages. Regarding the latter, PDA is developing a technical report on use of
QRM (avoiding drug shortages), and one of the workshop presentations will discuss this topic.
Finally as noted in ICH Q9, risk management is only as good as the currency, sufficiency
and accuracy of the knowledge in an organization. This underscores the basic importance
of Knowledge Management to QRM. Yet when it comes to knowledge management, many
companies are still challenged with institutionalizing KM. Even though KM allows companies
to continuously learn about their products and our processes, many companies struggle with
how knowledge is effectively gathered and shared across the enterprise, from site to site,
and even between departments. Senior management awareness and escalation procedures
are also not always well defined or consistent. Because of its importance, KM will be a major
theme throughout our QRM workshop.
Sincerely,
Co-Chairs of the 2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality
Risk Management Program Planning Committee
Rick Friedman
FDA
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www.pda.org/ICHQ10
Anders Vinther, PhD
Sanofi Pasteur
Using Q10 to Make Compliance Synonymous with Quality Performance
November 3-5, 2014 | BALTIMORE MARRIOTT WATERFRONT | BALTIMORE, MARYLAND
General Information
COURSE REGISTRATION HOURS
Four Ways to Register
Thursday, November 6, 2014: 7:30 a.m. – 4:00 p.m.
1. Click www.pda.org/ICHQ10
DRESS/ATTIRE
2. Call
+1 (301) 656-5900 ext 115
3. Fax
+1 (301) 986-1093
4. Mail
PDA Global Headquarters
Bethesda Towers
4350 East West Highway
Suite 150
Bethesda, MD 20814 USA
Business casual attire is recommended for the 2014 PDA/FDA
Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk
Management. Since the temperature in meeting rooms tends to be
cool, please bring a jacket or sweater
for your comfort.
VENUE
Baltimore Marriott Waterfront Hotel 700 Aliceanna Street
Baltimore, MD 21202
Phone: +1 (410) 385-3000
Website: http://www.marriott.com
Rate: Single: $214.00, plus applicable state and local taxes.
Cut off Date: Book your reservations by Monday, October 6, 2014.
(A PDA block of rooms are available on a first come basis and must
be secured by the cut-off date to receive the PDA rate). After the
cut-off date, rooms will be available at the prevailing rate based
on availability.
WORKSHOP REGISTRATION HOURS
Monday, November 3: 7:00 a.m. – 5:30 p.m.
Tuesday, November 4: 7:00 a.m. – 5:15 p.m.
Wednesday, November 5: 7:00 a.m. – 2:15 p.m.
SPECIAL REQUIREMENTS
If you require special accommodations to fully
participate, please attach a written description of your
needs with your registration form. Specific questions
can be directed to [email protected].
CONTACT INFORMATION
Workshop Inquires
Leon D. Lewis Director, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 149 | Email: [email protected] Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115 | Email: [email protected]
PDA TRI Course Inquiries:
Stephanie Ko
Sr. Manager, Lecture Education
Phone: +1 (301) 656-5900 ext. 151 | E-mail: [email protected]
Exhibition/Sponsorship Inquiries:
David Hall
Vice President, Sales
Phone: +1 (301) 760-7373 | Cell: +1 (240) 688-4405
E-mail: [email protected]
Supporter and Exhibitor Opportunities are Available!
HHS has not endorsed any solicitations for this meeting. All donations have been applied exclusively towards defraying the expenses
of non-Federal co-sponsors, not HHS. HHS is not asking for any funds in any capacity.
The 2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management agenda will provide ample
opportunity for exhibitors to have face-to-face dialogue and direct information exchange with industry professionals who are
actively involved in this dynamic field. Company representatives will be on hand from operations, manufacturing, quality, regulatory
affairs, and other technical functions.
Become a supporter or exhibitor at the 2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk
Management and strengthen your brand image, increase your visibility, and gain access to leaders and subject matter experts in
the biopharmaceutical industry.
For more information about exhibitor and supporter opportunities, please contact:
David Hall, Vice President, Sales
Phone: +1 (301) 760-7373 | Cell: +1 (240) 688-4405
E-mail: [email protected]
www.pda.org/ICHQ10
3
2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management
2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management
2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management
Connecting People, Science and Regulation®
Monday, November 3, 2014 Agenda
7:00 a.m. – 5:30 p.m.
Registration Open
7:00 a.m. – 8:00 a.m.
Continental Breakfast
8:00 a.m. – 8:10 a.m.
Welcome and Opening Remarks from Co-Chair
Anders Vinther, PhD, Chief Quality Officer, Sanofi Pasteur and
Co-Chair, 2014 PDA/FDA Pharmaceutical Quality System Workshop
8:10 am. – 10:00 a.m.
Plenary 1 – Foundation Session Pt. 1
Moderator: Anders Vinther, PhD, Chief Quality Officer, Sanofi Pasteur
12:00 p.m. – 1:15 p.m.
Lunch
1:15 p.m. – 2:45 p.m.
Breakout Groups
Breakout Working Group Instructions: These breakout sessions
will provide the opportunity for participants to present their
views and concerns regarding three hot topics. Breakout sessions
will be repeated the next day so each attendee will have the
opportunity to attend their two preferred breakout groups during
the workshop. Facilitators will summarize breakout discussions
and outcomes on the last day of the workshop.
Session Description: It’s been more than a decade since the ICH
Q10 document was completed and in the time since finalization
it has helped structure how we all work with quality systems
across our industry and within our companies. We have learned
that a fundamental element of Quality Systems implementation
is strong having organizational competency in the area of
risk management. In this two part session, presenters will
provide an overview of how risk management is done most
effectively. In addition to Quality Risk Management (QRM), the
other quality system enabler, Knowledge Management (KM),
will be emphasized. Attendees will be provided with practical
applications of various QRM tools and formality spectrum, and
case studies that illustrate how other industries have made
substantial progress within the implementation of KM and QRM.
Breakout Group 1 – QRM Current State, Opportunities
and Challenges
8:10 a.m. – 8:40 a.m.
Implementation of KM and QRM: The Space Shuttle Experience
Edward Hoffman, PhD, Chief Knowledge Officer and APPEL
Director, NASA
Industry Facilitator: Sharon Timmis, Vice President, Operational
Excellence, Pfizer, Inc.
8:40 a.m. – 9:10 a.m.
QRM Current State in the Pharmaceutical Industry
and Opportunities
Martin Lush, Vice President, Pharma Biotech, NSF-Health Sciences
FDA Facilitator: Michael Smedley, Deputy Director, OMPQ, CDER, FDA
9:10 a.m. – 9:40 a.m.
KM Programs and Strategies that Work in Other Industries
Jay Liebowitz, DSc, DiSanto Visiting Chair, Applied Business and
Finance, Harrisburg University of Science and Technology
9:40 a.m. – 10:00 a.m.
Questions and Answers/Discussion
10:00 a.m. – 10:45 a.m.
Refreshment Break in Exhibit Area
10:45 a.m. – 12:00 p.m.
Plenary 2 – Foundation Session Pt. 2
Moderator: Robert Woolfenden II, Principal Engineer, Amgen, Inc.
10:45 a.m. – 11:15 a.m.
ICH Q8, Q9 and Q10 Overview of QRM and KM Expectations
GK Raju, PhD, Chairman and CEO, Light Pharma Inc.
11:15 a.m. – 12:00 p.m.
Practical Application of Various QRM Tools and the Formality Spectrum
Emma Ramnarine, Senior Director, Head Global Biologics QC
Network, Genentech Inc.
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www.pda.org/ICHQ10
FDA Facilitator: Robert McElwain, Consumer Safety Officer, OCBQ,
CDER, FDA
Industry Facilitator: GK Raju, PhD, Chairman and CEO,
Light Pharma Inc.
Breakout Group 2 – Human Errors – How Do You Proactively
Identify and Mitigate Risks?
FDA Facilitator: Rick Friedman, Associate Director, OMPQ, CDER,
FDA and Co-Chair, 2014 PDA/FDA Pharmaceutical Quality System
Workshop
Breakout Group 3 – QRM for Legacy Products and Facilities
Industry: Emma Ramnarine, Senior Director, Head Global Biologics
QC Network, Genentech Inc.
2:45 p.m. – 3:15 p.m.
Refreshment Break in Exhibit Area
3:15 p.m. – 5:00 p.m.
Plenary 3 – Quality Risk Management Expectations
and Incorporation into National Requirements –
Regulatory Perspectives
Moderator: Sharon Timmis, Vice President, Operational
Excellence, Pfizer, Inc.
Session Description: This session will present the EU and
US regulatory agencies expectations regarding Quality Risk
Management. Participants will have the opportunity to hear
crucial updates from the US FDA and European regulatory officials
followed by a panel discussion which will allow additional
questions and in-depth discussions.
3:15 p.m. – 3:45 p.m.
EU Update and WHO Expectations
MRHA Representative Invited
Using Q10 to Make Compliance Synonymous with Quality Performance
November 3-5, 2014 | BALTIMORE MARRIOTT WATERFRONT | BALTIMORE, MARYLAND
Monday, November 3 – Tuesday, November 4, 2014 Agenda
Plenary 3 – Quality Risk Management Expectations
and Incorporation into National Requirements –
Regulatory Perspectives (continued)
3:45 p.m. – 4:15 p.m.
US FDA Update
Rick Friedman, Associate Director, OMPQ, CDER, FDA
4:15 p.m. – 5:00 p.m.
Questions and Answers/Panel Discussion
PANELISTS:
H. Gregg Claycamp, PhD, Senior Scientist, Risk Analysis and
Decision Analysis, CVM, FDA (Invited)
Rick Friedman, Associate Director, OMPQ, CDER, FDA
MHRA Panelist Invited
GK Raju, PhD, Chairman and CEO, Light Pharma Inc.
Emma Ramnarine, Senior Director, Head Global Biologics QC
Network, Genentech Inc.
5:00 p.m. – 6:15 p.m. Networking Reception in Exhibit Area
Tuesday, November 4, 2014
7:00 a.m. – 5:15 p.m. Registration Open
7:00 a.m. – 8:00 a.m.
Continental Breakfast
8:00 a.m. – 10:00 a.m.
Plenary 4 – The Road to Better Risk Identification
and Root Cause Analysis
Moderator: Robert Woolfenden II, Principal Engineer, Amgen, Inc.
Session Description: True lifecycle QRM is being enabled by
various organizational and systemic evolutions in the industry.
These often include Human Error Analysis, 6-Sigma, Operational
Excellence, and SPC elements. This session will provide
attendees with a deeper look into these evolutions through a
series of case studies. Participants will also be given a first-hand
look at how human error analysis is being used to improve risk
identification in both pharma and non-pharma industries.
8:00 a.m. – 8:30 a.m.
Integrating QRM into the Quality System: How to Make it Happen
(Evolution in Competencies, Organization, and Systems)
Elise Vallet, Associate Vice President, Global Quality Risk
Management, Sanofi Pasteur
8:30 a.m. – 9:00 a.m.
A Generic Perspective on Operational Excellence: Program
Implementation and Case Studies
Menny Meirom, Vice President, Operational Excellence,
Teva Global Operations
9:00 a.m. – 9:30 a.m.
An Innovator Perspective on Operational Excellence:
Program Implementation and Case Studies
Mark Swatling, Senior Director, Operational Excellence, AstraZeneca
9:30 a.m. – 10:00 a.m.
Human Error Analysis for Risk Identification and Control Case Study
Lee Vanden Heuvel, Manager, Incident Investigation/Root Cause
Analysis Service and Senior Risk/Reliability Engineer, ABS Consulting
10:00 a.m. – 10:30 a.m.
Refreshment Break in Exhibit Area
10:30 a.m. – 12:30 p.m.
Plenary 5 – The 4 Quality System Elements: Moving from Reactive
to Proactive – Case Studies
Moderator: Ursula Busse, PhD, Head, GxP Regulations
Coordination, Quality Group, Novartis
Session Description: Effective Quality Risk Management (QRM) is
fundamental to the success of the Pharmaceutical Quality System
(PQS). This session illustrates through case studies how QRM can
be applied to different elements of the PQS to aid in the proactive
identification, scientific evaluation and control of potential risks
to quality. Focusing on the four critical quality system elements
mentioned in ICH Q10, the presentations will exemplify how
efforts and formality can be adapted to levels of risk, and how
QRM can support the identification and prioritization of areas for
improvement throughout the product lifecycle.
10:30 a.m. – 11:00 a.m.
Process Performance Product Quality Monitoring System – Monitoring
Various Quality Factors and Use of Statistical Process Control
Barbara Allen, PhD, Senior Director, Global Quality Systems,
Eli Lilly and Company (Invited)
11:00 a.m. – 11:30 a.m.
Change Management
Vivianne Arencibia, Vice President, Global Quality Audit and
Compliance, Novartis
11:30 a.m. – 12:00 p.m.
CAPA and Management Review
Anders Vinther, PhD, Chief Quality Officer, Sanofi Pasteur
12:00 p.m. – 12:30 p.m.
Questions and Answers/Panel Discussion
PANELISTS:
Barbara Allen, PhD, Senior Director, Global Quality Systems,
Eli Lilly and Company (Invited)
Vivianne Arencibia, Vice President, Global Quality Audit and
Compliance, Novartis
Menny Meirom, Vice President, Operational Excellence,
Teva Global Operations
Mark Swatling, Senior Director, Operational Excellence, AstraZeneca
Elise Vallet, Associate Vice President, Global Quality Risk
Management, Sonofi Pasteur
Lee Vanden Heuvel, Manager, Incident Investigation/Root Cause
Analysis Services and Senior Risk/Reliability Engineer, ABS Consulting
Anders Vinther, PhD, Chief Quality Officer, Sanofi Pasteur
12:30 p.m. – 1:45 p.m.
Lunch
1:45 p.m. – 3:15 p.m.
Breakout Groups
Breakout Working Group Instructions: These breakout sessions
will provide the opportunity for participants to present their
views and concerns regarding three hot topics. Facilitators will
summarize breakout discussions and outcomes on the last day
of the workshop.
www.pda.org/ICHQ10
5
2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management
2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management
2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management
Connecting People, Science and Regulation®
Tuesday, November 4 – Wednesday, November 5, 2014 Agenda
Breakout Groups (continued)
Wednesday, November 5, 2014
Breakout Group 1 – QRM Current State, Opportunities and Challenges
7:00 a.m. – 2:15 p.m. Registration Open
FDA Facilitator: Brooke Higgins, Consumer Safety Officer, OMPQ,
CDER, FDA (Invited)
Industry Facilitator: GK Raju, PhD, Chairman and CEO,
Light Pharma Inc.
7:00 a.m. – 8:10 a.m.
Continental Breakfast
Breakout Group 2 – Human Errors – How Do You Proactively
Identify and Mitigate Risks?
FDA Facilitator: Rick Friedman, Associate Director, OMPQ, CDER, FDA
Industry Facilitator: Sharon Timmis, Vice President, Operational
Excellence, Pfizer, Inc.
Breakout Group 3 – QRM for Legacy Products and Facilities
FDA Facilitator: Michael Smedley, Deputy Director, OMPQ, CDER, FDA
Industry: Emma Ramnarine, Senior Director, Head Global Biologics
QC Network, Genentech Inc.
3:15 p.m. – 3:45 p.m.
Refreshment Break in Exhibit Area
3:45 p.m. – 5:15 p.m.
Plenary 6 – Use of QRM in Facility and Process Design
Moderator: Robert Roy, Director, Aseptic Technology, IPS
Session Description: Effective application of QRM principles
during design activities offers the best opportunity for proactive
risk mitigation, through application of appropriate engineering
controls and integration of new technologies. In order to
achieve best results, advance preparatory work is required to
develop QRM tools that are well suited to the dynamic design
environment and to complete technical evaluations for potential
new technologies. The budgetary implications of potential new
technologies should also be previewed, to avoid elimination
of these technologies due to missing or incomplete financial
justifications. With proper preparation, a true “lifecycle”
approach to product quality can be realized.
This session emphasizes a QRM framework for evaluation and
ranking of risks in the design process, and explores application
and implications of new technologies for tablet facilities and
processes. In combination, these activities can result in significant
risk reduction or elimination as well as tremendous cost savings
due to avoidance of quality issues throughout the facility
lifecycle. This session will demonstrate the organizational value of
programs, and will provide a basis for their development.
3:45 p.m. – 4:15 p.m.
Sterile Facility and Sterile Equipment Design – Failure Modes
and Risk Hierarchy
Hal Baseman, Principal, Valsource LLC
4:15 p.m. – 4:45 p.m.
Tablet Facility Process and Equipment Design
James Drennen III, PhD, Associate Dean, Research and Graduate
Programs, Pharmaceutical Sciences, Duquesne University
4:45 p.m. – 5:15 p.m.
Questions and Answers/Discussion
6
www.pda.org/ICHQ10
7:00 a.m. – 8:00 a.m.
Breakfast Session – Risk Management: Managing Uncertainty
through Sound Lifecycle Management and Innovation
Moderator: Emma Ramnarine, Senior Director, Head Global
Biologics QC Network, Genentech Inc.
Session Description: This session will provide an overall review of
the analytical control systems lifecycle management followed by
a case study of the implementation of the PCR based analytical
technology used for an adventitious agent testing. Participants
will be provided with examples on how well the process went
when transitioning from the traditional ways of testing to the
new technology.
7:00 a.m. – 7:20 a.m.
Risk Management of Analytical Control Systems:
Lifecycle Management
Paul Motchnik, Senior Scientist, Genentech, Inc.
7:20 a.m. – 7:40 a.m.
Implementation of PCR Based Analytical Technology for Adventitious
Agent Testing: Transitioning from Traditional to the New Technology
Helene Gazzano-Santoro, PhD, Director, Head Bioassay
Technologies, Analytical Development & Quality Control,
Genentech, Inc.
7:40 a.m. – 8:00 a.m.
Questions and Answers/Discussion
8:10 a.m. – 9:30 a.m.
Plenary 7 – The Use of QRM in Your Audit Program and Inspections
Moderator: Anders Vinther, PhD, Chief Quality Officer, Sanofi Pasteur
Session Description: How do we establish and maintain an
acceptable oversight of our vendors and contract organizations in
q highly complex global supply chain? How do we best leverage
resources to focus on the more challenging sites/companies, or
unstable operations? The answer to this is a robust QRM program
applied intelligently. This session will show examples of exactly
this in terms of suppliers, self-audits and regulatory inspections.
8:10 a.m. – 8:30 a.m.
Conducting CMO and Vendor Audits
Janeen Skutnik-Wilkinson, Vice President, NSF-Health Sciences
8:30 a.m. – 8:50 a.m.
Conducting Internal Audits (Self Audits)
Dwayne Greathouse, Senior Director, Global Compliance and
Audits, Hospira, Inc.
8:50 a.m. – 9:10 a.m.
Conducting Regulatory Inspections
IMB Representive Invited
9:10 a.m. – 9:30 a.m.
Questions and Answers/Discussion
Using Q10 to Make Compliance Synonymous with Quality Performance
November 3-5, 2014 | BALTIMORE MARRIOTT WATERFRONT | BALTIMORE, MARYLAND
Wednesday, November 5, 2014 Agenda (continued)
9:30 a.m. – 10:00 a.m.
Refreshment Break
10:00 a.m. – 12:00 p.m.
Plenary 8 – QRM in the Drug Lifecycle
Moderator: Janeen Skutnik-Wilkinson, Partner, NSF DBA
Session Description: This session will look at how the elements
and tools of the PQS can be applied to process development of
drug substance and drug product, and enhance the potential for
a smooth technology transfer into commercial launch. It will also
address excipient risks.
10:00 a.m. – 10:30 a.m.
Supply Chain: From Raw Material to Finished Product
Brian Johnson, Senior Director, Supply Chain Security, Pfizer, Inc.
and Chair, Rx-360
10:30 a.m. – 11:00 a.m.
Knowledge Management During Tech Transfer:
From Development to Commercial
Kevin Nepveux, Vice President, Global Technology Services, Pfizer, Inc.
11:00 a.m. – 11:30 a.m.
Why Your QRM Is a Living Document
FDA Representative invited
11:30 a.m. – 12:00 p.m.
Questions and Answers/Discussion
12:00 p.m. – 12:20 p.m.
‘Grab and Go’ Break
12:20 p.m. – 12:50 p.m.
Plenary 9 – Report Out
Moderator: Anders Vinther, PhD, Chief Quality Officer, Sanofi Pasteur
Session Description: During this session each industry facilitator
from the previous breakout sessions will be given 10 minutes apiece
to summarize the key discussion points from their breakout group.
12:20 p.m. – 12:30 p.m.
Group 1 Report Out
GK Raju, PhD, Chairman and CEO, Light Pharma Inc.
12:30 p.m. – 12:40 p.m.
Group 2 Report Out
Sharon Timmis, Vice President, Operational Excellence, Pfizer, Inc.
12:40 p.m. – 12:50 p.m.
Group 3 Report Out
Emma Ramnarine, Senior Director, Head Global Biologics QC
Network, Genentech Inc.
1:00 p.m. – 1:50 p.m.
Plenary 10 – Closing Keynote: Success Stories
Moderator: Rick Friedman, Associate Director, OMPQ, CDER, FDA
Session Description: This session will provide a high-level
overview of the W. Edward Deming’s 14 points and his system of
profound knowledge as best described in his book “Out of the
Crises” and how to apply it to the pharmaceutical industry.
Plenary 10 – Closing Keynote: Success Stories (continued)
1:00 p.m. – 1: 30 p.m.
Deming 14 Principles for Management
Deming Institute Representative Invited
1:30 p.m. – 1:50 p.m.
Questions and Answers/Discussion
1:50 p.m. – 2:15 p.m.
Closing Remarks and Adjournment from Co-Chair
Rick Friedman, Associate Director, OMPQ, CDER, FDA and Co-Chair,
2014 PDA/FDA Pharmaceutical Quality System Workshop
Continuing Education Credits
The PDA Training and Research Institute is accredited by the
Accreditation Council for Pharmacy Education (ACPE) as a
provider of continuing pharmacy education. Participants may
sign up to receive Continuing Pharmacy Education (CPE) credits. To do so,
participants must sign in at the beginning of the program, submit the
provided evaluation forms and mail the CPE credit request to the address
stated on the form. Attendees must be present at the full event to receive
Continuing Pharmacy Education credit, which will be awarded as follows:
2014 PDA/FDA Pharmaceutical Quality System (ICH Q10)
Workshop on Quality Risk Management
ACPE #0116-0000-14-044-L04-P | 1.767 CEUs
Type of Activity: Knowledge
This unique workshop will allow participants to learn internationally
harmonized quality risk management principles and benefit from
actual case studies of practical implementation. Upon completion of this ICH Q10 workshop, participants will be able to
• Summarize international regulatory expectations for Quality Risk
Management and Knowledge Management, in the light of ICH Q8,
Q9 and Q10
• Explain how QRM can be used to enable consistent
manufacturing performance and reliable supply
• State how to reduce quality, compliance, and business risks by
applying Quality Risk Management both proactively and when
resolving complex manufacturing issues
• Identify practical approaches and tools for QRM implementation
across the product and process lifecycle
• Explain how systematic manufacturing and quality improvements
can be made by applying QRM in the various elements of the
Quality System
• Describe the management role in supporting and implementing QRM
and Knowledge Management, and the benefits
reaped by quality-focused decision making
PDA will be offering
• Outline how to improve both efficiency and
an educational
predictability of operations by more accurately
course following
assessing and effectively managing risk
the 2014 PDA/FDA
WHO SHOULD ATTEND
Pharmaceutical Quality
System (ICH Q10)
Department Workshop on Quality
Quality | Manufacturing | Regulatory Affairs |
Risk Management. For
Technical Operations | Research & Development
more information,
Job Function please visit
Senior Managers | Quality Assurance/Control |
www.pda.org/calendar
Senior Scientists | Executive Management | Writers
of Investigations | Technical Experts
www.pda.org/ICHQ10
7
2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management
2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management
Parenteral Drug Association Training and Research Institute (PDA TRI)
Aseptic Processing is the heart of PDA’s core competencies. Our most
popular course, the two-week Aseptic Processing Training Program,
provides an in-depth, comprehensive learning experience into what
is involved with the manufacture of aseptically produced products
associated with manufacture of aseptically produced products, and our
other courses in this area complement that program.
ASEPTIC PROCESSING TRAINING PROGRAM
October 13-17 and November 3-7 | Bethesda, Maryland
www.pda.org/2014aseptic5
PDA TRI’s two-week comprehensive training program, taught by numerous industry leading
experts in their fields with over 300 years of combined experience, will give you and your
personnel the training and information needed to properly evaluate and improve your aseptic
processes to ensure sterile products. This course provides 50 hours of hands-on laboratory
training, equipping you with tools and actual experience you can bring home and apply
immediately on the job.
RECOMMENDED PRACTICES FOR MANUAL ASEPTIC PROCESSES
November 12-13 | Bethesda, Maryland
www.pda.org/MAP1
This course will provide valuable and practical insights into the
technological challenges associated with designing, operating and
evaluating manual aseptic processes. Participants will come away with an
understanding of how manual aseptic processes differ from automated
ones, and what should be addressed as they work with manual aseptic
processes in their own plants. They will also learn how process simulation
testing should be designed and carried out to evaluate the manual aseptic
processing operation.
QUALITY SYSTEMS FOR ASEPTIC PROCESSING
November 17-21 | Bethesda, Maryland
www.pda.org/quality
Optimize your Quality Systems associated with Aseptic Processing. You will receive a blend of
theoretical knowledge in the lecture setting and hands-on application in PDA’s clean room and
microbiology laboratories, which provide the complete learning experience.
Register before
September 19, 2014
and Save Big!
The Parenteral Drug Association presents the...
2014 PDA
Pharmaceutical Quality
Metrics Conference
December 2-4, 2014
OMNI SHOREHAM HOTEL | WASHINGTON, DC
PDA is excited to announce a follow-up conference to the well attended 2014 PDA Pharmaceutical
Quality Metrics Conference. This year’s conference is also being co-chaired by FDA and will continue
the discussion on FDA’s utilization of robustness and compliance metrics as well as explore
opportunities for measuring quality systems and culture.
YOU WILL HEAR:
• Case studies from industries that have successfully promoted quality
culture to improve product quality
• Pharmaceutical leaders experiences and challenges for improving
corporate quality culture and quality management systems
• FDA’s thoughts and proposed actions for gathering quality metrics from
the pharmaceutical industry
• Detailed discussion and feedback on quality culture and on FDA’s new
quantitative measures program
• And much more
Immediately following the 2014 PDA Pharmaceutical Quality Metrics Conference, the PDA
Training and Research Institute will be hosting a course on Quality Metrics: Performance Indicators to
complement your learning on December 5.
CONFERENCE: DECEMBER 2-4
EXHIBITION: DECEMBER 2-3
TRI COURSE: DECEMBER 5
www.pda.org/metrics2014
Manufacturing Innovation and Efficiency: Achieving Quality
Performance in Sterile and Biopharmaceutical Operations
March 16-18, 2015 | RED ROCK RESORT AND CASINO | LAS VEGAS, NEVADA
CALL FOR POSTERS / CASE STUDIES
The 2015 PDA Annual Meeting Program Planning Committee encourages you to submit an abstract for a one-day poster presentation
at the 2015 PDA Annual Meeting, which will be held on March 16-18, 2015 in Las Vegas, NV. Abstracts must be noncommercial,
describe developments, strategies or work and significantly contribute to the body of knowledge relating to biopharmaceutical
manufacturing, process knowledge, quality management and technology. Abstracts related to sterile or related product manufacture
are preferable, but those addressing other technologies are welcome. Case studies are particularly desired. All abstracts will be
reviewed by the Program Planning Committee for consideration.
Suggested topics include, but are not limited to:
IMPROVING MANUFACTURING PERFORMANCE
• Manufacturing: Human error prevention
• Six Sigma
• Process Validation/ Lifecycle Approach
• Supply Chain
• Technology and Knowledge Transfer
• Bioburden and Biofilm Management
CHANGING REGULATORY LANDSCAPE
• Quality Metrics
• Drug Shortages and Regulatory Submissions
• Serialization
• Track and Trace
• Counterfeit
• Product Surveillance
TECHNOLOGY, ADVANCES AND EXPECTATIONS
• Aging Facilities
• Challenges in Manufacturing
• Diagnostics
• Single Use Systems Technology
• Emerging Methods for Virus Detection and
Removal
• Virus Contamination in Biomanufacturing:
Risk Mitigation, Preparedness and Response
• Pharmaceutical Package Integrity Testing:
Industry Challenges, Technology and
Advancement
• Bioprocess/Downstream Purification Technology
• Continuous Manufacturing
Abstracts must be received by October 17, 2014 for consideration.
The committee may also consider abstracts for an oral presentation.
Submit your abstract now by visiting www.pda.org/2015annualmeeting/cfp
You will be advised in writing of the status of your abstract by November 14, 2014. Poster presenters are required to register as a
paid full conference attendee at the rate of $1,895 member/$2144 nonmember.
In order to be listed in the final program, your full conference registration and final abstract content must be received no later than
January 5, 2015. After January 5th, the prevailing registration fees and policies apply.
Visit www.pda.org/2015annualmeeting/cfp to submit an abstract.
For more information, please contact Stanley Kozlowski, Coordinator, Programs and Meetings
via email at [email protected] or phone at (301) 656-5900 ext. 165.
www.pdaannualmeeting.org
2014 PDA/FDA Pharmaceutical Quality System
(ICH Q10) Workshop on Quality Risk
Management (November 3-5, 2014)
Baltimore Marriott Waterfront | Baltimore, Maryland
Exhibition: November 3-4 | Course: November 6
Four easy ways to register – Click, fax, mail or call: Click: www.pda.org/ICHQ10 Fax: +1 (301) 986-1093 (USA);
Mail: PDA Global Headquarters, 4350 East West Highway, Suite 150, Bethesda, MD 20814 USA; Call: + 1 (301) 656-5900 ext 115
1 Contact Information
Prefix
PDA Membership Number:
Name (Last, First, MI)
Job Title
Company
Business Address
City
State/Province
Country
Email
Business Phone
Fax
ZIP+4/Postal Code
(Check only if you are substituting for a previously enrolled colleague; The fee difference in
the prevailing rate is due at the time of substitution. Please note that if you are a non-member
substituting for a member, you will be required to pay the difference in the non-member fee.)
 Substituting for
Please note: In order to receive the prevailing rate, your registration(s) with payment must be
received by PDA by 5:00 p.m. ET on or before the date noted.
* For this member type or discounted rate, online registration is not available and must be faxed in.
Special Dietary Requirements (Please be specific):
 Check here to become a member and receive the member price for this event. (Add $259 to your total.)
2 Conference Registration | November 3-5, 2014
Before August 22, 2014
PDA Member
 $ 1,495
Please check appropriate fee (US$).
Government/Health Authority
Member
Nonmember*
 $ 550
 $ 650
Nonmember
 $ 1,744
Academic
Member Nonmember*
 $ 550
 $ 650
Student
Member Nonmember*
 $ 280
 $ 310
August 22 – September 23, 2014
 $ 1,695
 $ 1,944
 $ 550
 $ 650
 $ 550
 $ 650
 $ 280
 $ 310
After September 23, 2014
 $ 1,895
 $ 2,144
 $ 550
 $ 650
 $ 550
 $ 650
 $ 280
 $ 310
Group Registration: Register 4 people from the same organization as a group (at the same time) for the conference
3 Payment Options
All cards are charged in US$. and receive the 5th registration free. Other discounts cannot be applied. All forms MUST be faxed in together.
 By Credit Card – Clearly indicate account number, expiration date and billing address.
Please bill my:  American Express  MasterCard  VISA
 Credit Card Guarantee Only
Total amount $
Account Number
Exp. Date
Name (exactly as it appears on card)
Signature
Billing Address (Billing address must match credit card statement)
City
State
Zip
Country
Wire Transfer Payments: If you require wire transfer, please contact [email protected].
PDA Federal Tax I.D. #52-1906152
CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you
have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by September 4, 2014 your
credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. If you are a non-member substituting for a member, you will
be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and
phone messages are not accepted). REFUNDS FOR FULL CONFERENCE/EVENTS: If your written request in received on or before September 4, 2014 you will receive a full refund minus a $200 processing fee. After that time, no
refunds or credit requests will be approved. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors
without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due
to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900. PLEASE NOTE THAT PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ON-SITE. THIS IMPORTANT SECURITY
PROCEDURE WILL PREVENT ANYONE OTHER THAN THE REGISTRANT FROM PICKING UP THEIR BADGES AND MATERIALS. RECORDING/PHOTO RELEASE: By registering for this event, I authorize PDA the right to record
and photograph me to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/
photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA conferences.
PDA USE ONLY Date:
Check:
Amount:
Account:
1103
PDA GLOBAL HEADQUARTERS
4350 East West Highway
Suite 150
Bethesda, MD 20814 USA
Phone: +1 (301) 656-5900
Fax: +1 (301) 986-0296
2014 PDA/FDA Pharmaceutical
Quality System (ICH Q10) Workshop
on Quality Risk Management
Using Q10 to Make Compliance
Synonymous with Quality Performance
November 3-5, 2014
BALTIMORE MARRIOTT WATERFRONT
BALTIMORE, MARYLAND
EXHIBITION: NOVEMBER 3-4
COURSE: NOVEMBER 6
www.pda.org/ICHQ10
Register before
August 22, 2014
and save on
registration
2014 PDA/FDA Pharmaceutical
Quality System (ICH Q10)
Workshop on Quality Risk Management
Using Q10 to Make Compliance
Synonymous with Quality Performance
November 3-5, 2014
Preliminary
Agenda
Inside
BALTIMORE MARRIOTT WATERFRONT
BALTIMORE, MARYLAND
EXHIBITION: NOVEMBER 3-4
COURSE: NOVEMBER 6
www.pda.org/ICHQ10