FDA-ISPE Collaboration: Pharmaceutical Quality Systems (E06)

9-10 June CEUs: 1.2

As part of FDA’s Pharmaceutical cGMP for the 21^st Century Initiative, the Agency, along with industry leaders and regulatory agencies from other countries, have identified key components of a modern pharmaceutical quality system in ICH Q10. This two-day seminar will provide a special forum for the exchange of information between the FDA and the pharmaceutical industry and will focus on pharmaceutical quality systems and the implementation of elements that enhance its effectiveness. This is a special opportunity for interaction of FDA and industry to discuss the practical application of ICH Q 10. Topics will include Technology Transfer, CAPA, Knowledge Management, Batch Release, PAT, and Practical Scale-Up Considerations. We will also discuss process performance and product quality monitoring as an additional direction that PQLI is addressing.

Co-sponsored by the FDA, these highly-interactive sessions will provide a forum for an exchange of ideas, and an interface between regulators and industry. Above the standard Q&A sessions, there will be a “Town Hall Forum” for you to pose your questions to the regulators and receive their candid assessment of your concerns. This session will include content of global interest.

How You Will Benefit

At the conclusion of this session, participants will be able to:

Explain key components of a modern pharmaceutical quality system
Examine the significance of ICH Q10 guidance and its impact regionally and globally
Illustrate how modern pharmaceutical quality systems enhance an understanding of drug products and drug manufacturing processes, and facilitate continuous improvement of products and processes
Describe how concepts associated with modern pharmaceutical quality systems are giving direction to regulatory initiatives
Understand end to end lifecycle management of a product through implementation of the process perform and product quality monitoring of ICH Q10

Who Should Attend

Quality and compliance professionals, supply chain, regulatory affairs professionals, pharma manufacturing professionals engaged in risk management activities, PAT, formulators of drug delivery systems, CMOs, and tech transfer professionals

Leaders

Joseph Famulare, Senior Director, Genentech Inc, USA
Grace McNally, Consumer Safety Officer, FDA/CDER/Office of Compliance, USA

Speakers

Deborah Autor, Director Office of Compliance, FDA, USA
Deborah Baly, Director, Product Quality Mgmnt, Genentech, USA
Monica Caphart, Invited, Consumer Safety Officer, FDA, USA
Rose Mary Dollard, Director Regulatory Compliance, Johnson & Johnson, USA
Natalie Garrett, Abbott, USA
Tara Gooen, LCDR, PHS, Team Leader, FDA/CDER/DMPQ, USA
Rob Hughes, Programme Director, Continuous Improvement, AstraZeneca, United Kingdom
Larry Kranking, President & CEO, Coldstream Laboratories, INC., USA
Martin Lipa, Director, Merck Mfg IT, Merck, USA
Bryan Liptzin, Director, Corporate Quality and Compliance, Amgen Inc, USA
Rosa Motta, Consumer Safety Officer, FDA, USA
Mary Oates, VP/ QO Leader, Pfizer, USA
Russ Somma, PhD, President, SommaTech, LLC, USA
Krista Terry, Principal Quality Risk Mgmnt Specialist, Genentech, USA
Kristy Zielny, Biologist, FDA, USA

Communities of Practice (COPs)

Examples for industry will probably be from these sectors:

API
Critical Utilities
OSD
PAT
Product Process Development

Knowledge Elements

1 - Product Development
- A. Formulation, clinical phases, and manufacture
- B. Technology transfer
4 - Supply chain management
5 - Production systems
- C. Production Control
7 - Quality systems
- A. Risk management and Quality Management System (QMS)

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.