SQA Webinar: Navigating Pharmaceutical Quality vs. Cost in the Age of Globalization: Stories from FDA's Foreign Offices
This online webinar will be given via Zoom.
Presented by: Peter Baker, Live Oak Quality Assurance LLC
Sponsored by: Beyond Compliance Specialty Section (BCSS)
Webinar Category: Regulatory
Regulatory Area of Interest: GCP, GLP, GMP
Description: This webinar focuses on the generic drug boom in the United States (US) that was driven by the passage of the Hatch-Waxman Act in 1984. As every story has multiple perspectives, this webinar will come from the perspective of an ex-FDA regulator, who was responsible for foreign inspections of generic drug manufacturers. The speaker will present the basic historical information on the Hatch-Waxman Act and the intended purpose of the incentive as well as the unexpected outcomes/challenges including fraud, balancing international political relationships, and more. The presenter will include their particular role and viewpoint of this generic drug boom including ethical, logistical, and political challenges that they had to manage as an FDA inspector. As we often have limited viewpoints that are based on our own limited experiences, the goal of this webinar is to share a different perspective to the US generic drug boom and encourage opening dialogue across the industry and regulators regarding challenges and possibilities for growth.
RQAP Units Approved: 1 nonGCP | nonGLP