2011 PDA/FDA Joint Regulatory – C5 - Supply Chain

Web Code: PDAFDAC511
Member/Nonmember Price: $75

Seminar Summary

CDER's Office of Compliance (OC) has targeted supply chain security as one of its top priorities this year.  There are risks to the security, safety, availability and serious challenges inherent in the global pharmaceutical supply chain that can harm patients and hurt companies.  Many, including the FDA, have stated that industry needs better systems in place for safeguarding its products and must start thinking about where the gaps are and what is missing in its supply chain controls. “The biggest risk is the risk we haven’t thought of.” This Supply Chain seminar will present case studies with tangible solutions for securing global pharmaceutical supplies.

Who Should Attend

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

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

Presenters Bio

Claire Barber, Head of Global Product Security, AstraZeneca UK Limited

Claire Barber is the Head of Global Product Security at AstraZeneca. She leads AZ’s anti-counterfeiting activities, implementing and developing strategies that give a holistic response to the challenges of ensuring patients receive genuine products supplied by AstraZeneca. In addition Claire has been an active member of the EFPIA Coding Project team for more than 3 years advising on supply chain related issues.

Claire has a Masters Degree in Engineering from Brunel University, and 21 years experience in a variety of engineering, manufacturing, supply chain and project / programme management roles in the Pharmaceutical industry, both in the UK and internationally.

Steven Wolfgang, PhD, Acting Associate Director, Risk Science, Intelligence and Prioritization, CDER, FDA

Dr. Steven Wolfgang is Acting Associate Director for Risk Science, Intelligence and Prioritization in the CDER Office of Compliance’s new Office of Drug Security, Integrity and Recalls (ODSIR).   This office was formed this year to address all drug supply chain-related issues within FDA.  In his 6.5 years at FDA Dr. Wolfgang has been involved in various activities aimed at promoting security and integrity throughout the drug component and finished drug supply chains.  These activities include writing guidance for incorporation of Physical-Chemical Identifiers into drug products, participating in research activities for the development of analytical screening tools, and identifying gaps in excipient monographs that are currently being implemented via the USP compendial modernization initiative.   Prior to joining FDA, Steve spent 15 years as a technical support chemist with the API and excipient manufacturing division of a large generic drug manufacturing firm.   He has a Ph.D. in Inorganic Chemistry from the City University of New York and a B.A. in Chemistry from Queens College (also in New York City.)

Registration contact

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