Whether you are looking for education on compliance strategies, quality, product development, manufacturing, or regulatory affairs, this conference was planned from an industry point of view. Next month’s conference was planned by Conference Chairs, Joe Famulare and Tom Cosgrove, who together bring more than 30 years of FDA experience in compliance around CGMP, labeling and product quality.
Joe Famulare joined Genentech in 2009 after a 32 year career at FDA as a former Deputy Director in the CDER Office of Compliance who led an extensive team heading GMP, GCP and GLP Compliance programs. Famulare now serves as Vice President of Global Quality Compliance and External Collaboration at Genentech and has been integral in aligning industry and international regulatory authorities around policy and harmonization while also heading the company’s inspection readiness, GMP auditing and determining compliance strategies. His extensive background includes stints as a founding member on the Council of Pharmaceutical Quality, 15 years as an ISPE member serving on the CGMP Executive Planning Committee, Chair of ISPE’s PQLI Initiative, member of the International Leadership Forum (ILF), ISPE Regulatory Compliance Committee as well as being active in ISPE global activities as a speaker and panelist.
Tom Cosgrove, Acting Director of the Office of Manufacturing and Product Quality (OMPQ), within the FDA’s Center for Drug Evaluation and Research (CDER), directs CDER’s compliance activities with respect to CGMP and product quality. Before OMPQ, Cosgrove led CDER’s Office of Unapproved Drugs and Labeling Compliance (OUDLC), where he was responsible for FDA’s Compliance divisions covering drug approval and labeling issues. Prior to joining CDER, he was a litigator in FDA’s Office of Chief Counsel and an attorney at Covington & Burling in DC as well as clerked for Judge Catherin Blake on the US District Court for the District of Maryland. Learn more about ISPE-FDA CGMP Conference here.