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DIA 2021 Global Annual Meeting


COVID-19 Pandemic and Beyond: Challenges Performing Inspections, Current State of Manufacturing Facility Regulatory Oversight Tools, and Learnings

Session Chair(s)

Andrew  Chang, PhD

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)

Olivia  Shopshear, MS

Industry Perspectives and Recommendations on Approaches to Manufacturing Facility Assessments During COVID-19 and the Post-pandemic Recovery Period

Olivia Shopshear, MS

  • Senior Director, Science and Regulatory Advocacy
  • Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Mark  Birse, MBA, MSc

Regulatory GMP Desk-Top Assessments: Mutual Recognition and Reliance Programs

Mark Birse, MBA, MSc

  • Vice President, Technical
  • Parexel International, United Kingdom
Stephan  Roenninger, DrSc, PhD

Future Opportunities on Routine and Pre-approval Inspections: A Matter of Opinion

Stephan Roenninger, DrSc, PhD

  • Director, Quality External Affairs
  • Amgen (Europe) GmbH, Switzerland
Andrew  Idzior, MS

FDA Update

Andrew Idzior, MS

  • Chemist and Interdisciplanary Scientist, OPMA, OPQ, CDER
  • FDA, United States