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COVID-19 Pandemic and Beyond: Challenges Performing Inspections, Current State of Manufacturing Facility Regulatory Oversight Tools, and Learnings
Session Chair(s)
Andrew Chang, PhD
Vice President, Quality and Regulatory Compliance
Novo Nordisk, Inc., United States
In this session, speakers from the FDA and regulated industry will share their perspectives and learnings regarding the impact of COVID-19 on inspections, the implementation of new tools that allow for the continued regulatory oversight of manufacturing facilities in the face COVID-19-related travel restrictions and other challenges (e.g., inspections conducted using innovative remote technologies), and challenges and opportunities for pandemic recovery and future pandemic preparedness. Topics in this session will include, but are not limited to: (1) the current tools being utilized by the FDA to assess manufacturing facilities, such as remote interactive evaluations, (2) experiences, learnings, and challenges related to the FDA’s use of alternative tools, (3) industry perspectives and recommendations on ways to further enhance FDA’s risk-based oversight of manufacturing facilities, and (4) lessons learned and future opportunities for routine surveillance inspections, pre-license inspections (PLIs) and pre-approval inspections (PAIs), and mutual recognition and reliance programs.
Learning Objective : Gain familiarity with available alternative tools utilized by FDA to assess manufacturing facilities; Describe industry perspectives and recommendations with respect to FDA’s risk-based oversight of manufacturing facilities; Describe lessons learned by your industry peers on remote/virtual inspections and other types of remote/virtual facility assessments; Identify MRAs and reliance programs and how alternative tools do- or don't fit within current frameworks.
Speaker(s)
Industry Perspectives and Recommendations on Approaches to Manufacturing Facility Assessments During COVID-19 and the Post-pandemic Recovery Period
Olivia Shopshear, MS
Biogen, United States
Senior Director, US Regulatory Policy Lead
Regulatory GMP Desk-Top Assessments: Mutual Recognition and Reliance Programs
Mark Birse, MBA, MSc
Parexel International, United Kingdom
Vice President, Technical
Future Opportunities on Routine and Pre-approval Inspections: A Matter of Opinion
Stephan Roenninger, DrSc
Amgen (Europe) GmbH, Switzerland
Director, Quality External Affairs
FDA Update
Andrew Idzior, MS
FDA, United States
Chemist and Interdisciplanary Scientist, OPMA, OPQ, CDER
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