2011 PDA/FDA Joint Regulatory Conference – P4 - Compliance Update

Web Code: PDAFDAP411
Member/Nonmember Price: $75

Seminar Summary

This seminar will feature the Compliance Directors from the FDA Centers (CBER, CDER, CDRH and CVM), as well as the Office of Regulatory Affairs (ORA).  Each of the Directors will provide their perspective on current compliance issues affecting the manufacture, testing and distribution of biopharmaceutical products, active drug substances and drug products and medical devices and combination products.  Following a brief presentation by each of the five participants, there will be ample time for a Q and A session, where the presenters will take and respond to questions from the floor.  This session is always a Conference highlight; come prepared with your questions and don’t miss this great opportunity to hear the latest in the compliance area.

Who Should Attend

Departments
Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales

Job Functions
Supply Chain | Clinical Supply Material Preparation | Executive Management

Presenters Bio

Mary Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA

Eric Nelson, Director, Division of Compliance, CVM,FDA

Steve Silverman, Director, Office of Compliance, CDRH, FDA

Richard L. Friedman, Associate Director, Office of Manufacturing and Product Quality (acting), CDER/OC, FDA

Steven Lynn, Director (acting), Office of Manufacturing and Product Quality (OMPQ), CDER, OC, FDA

Armando Zamora, Acting Director, Office of Enforcement, ORA, FDA

Registration contact

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org

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