2011 PDA/FDA Joint Regulatory Conference – P3 - Recall Lessons

Web Code: PDAFDA-P3
Member/Nonmember Price: $75

Seminar Summary

The heightened visibility of recalls in the past year has highlighted the need for having a robust process for handling recall actions.  Recalls demand not only significant pre-planning to ensure efficient operation of the quality unit, but also well-defined processes for materiel handling and communicating with stakeholders (government agencies, consumer protection groups, and consumers).  We will explore some of these dynamics in this plenary session with an emphasis on highlighting lessons that can be learned from the recall experience of the overall manufacturing sector in the recent past.

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

Dirk Gibson, PhD, Associate Professor of Communication and Journalism, University of New Mexico

Professor Gibson has been with the Department of Communication & Journalism at the University of New Mexico since 1996. He created the Product Recall Research Group in 1999. In 2002-2001 he conducted a national study of regulatory and regulatory recall polices at the behest of the Food Safety & Inspection Service of the USDA. That same year he made a presentation at a CPSC national forum on improving recall outcome.

Israel Santiago, Lead Consumer Safety Officer, CDER, FDA

In 1985 Mr. Santiago joined the federal government as a pharmacy technician in the VA hospital in San Juan, P.R., after attending the University of Puerto Rico where he studied chemistry and pharmacology. In 1990, Israel continued his federal career by joining the FDA in the San Juan District. While in San Juan District Israel gained experience in the area of Imports and he conducted inspections of foods, drugs, devices, IRB and hurricane disaster recovery work. In this role he developed expertise in conducting drug pre-approval, GMP and for-cause inspections, both domestically and in foreign countries.  Israel transferred to ORA headquarters in 2000, where he served as the National Consumer Complaint Coordinator managing the FACTS Consumer Complaint System for all of ORA. He subsequently became a Supervisor in the Office of the Commissioner, Office of Emergency Operations in 2003 where he managed the coordination of the Agency's response to emergency situations involving FDA regulated products such as outbreak investigations, man-made and natural disasters, the Agency's coordinated response through FEMA, and with other federal, state and foreign governments. In 2007 Israel accepted a position in CDER Office of Compliance in the Recalls Branch. There he help develop standarize the business processes of the branch and further develop the responsibilities of the branch to assure an Office of Compliance-wide coordinated approach to events to assure the containment of drug products that posed a risk to consumers. In this role he became the focal point of contact coordinating Office of Compliance' response to the Heparin Crisis in 2008; and in that same year he was selected as a Team Leader in the Recalls Branch.  In this role he has actively accepted the role of Branch Chief representing and leading the Recalls Branch in developing policy, procedures and in precedent setting events.  

Raymond Godlewski, Vice President, Quality and Compliance, MedImmune LLC

Raymond P. Godlewski Sr. R. Ph is currently the Vice President, Quality and Compliance, MedImmune, where he is responsible for global quality and compliance for research and development activities and commercial operations. Prior to joining MedImmune in April of 2011, Mr. Godlewski held positions of increasing responsibility in manufacturing, quality assurance and quality control at Ayerst, Abbott Laboratories, Wyeth and Baxter Healthcare. Mr. Godlewski was a contributor in the development of PDA Technical Report No. 43, has served on the Rx-360 Board of Directors and has spent the majority of his 29 year industry career in the area of aseptic processing.   Mr Godlewski received his Bachelors Degree in Pharmacy from Albany College of Pharmacy in Albany, New York.

Karthik Iyer, Consumer Safety Officer, DMPQ, CDER, FDA

Karthik Iyer is a Consumer Safety Officer/Statistician (ASQ CQE, CSSBB) in the Office of Manufacturing and Product Quality that resides within the Office of Compliance in CDER. His main role is to support the office with CGMP statistical issues as it relates to drug manufacturing. Karthik has a BS in Chemical Engineering from the University of Illinois and a MBA from the University of Iowa. Prior to joining FDA in 2010, Karthik has over eleven years cumulative work experience in the chemicals, consumer products, and refining industries with an emphasis on manufacturing statistics.

Registration contact

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