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Wednesday, June 30 • 2:00pm - 3:00pm
#343 SL: COVID-19 Pandemic and Beyond: Challenges Performing Inspections, Current State of Manufacturing Facility Regulatory Oversight Tools, and Learnings

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-623-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Andrew Chang, PhD

Speaker

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

Regulatory GMP Desk-Top Assessments: Mutual Recognition and Reliance Programs
Mark Birse, MBA, MSc

Future Opportunities on Routine and Pre-approval Inspections: A Matter of Opinion
Stephan Roenninger, DrSc, PhD

FDA Update
Andrew Idzior, MS


Speakers
avatar for Andrew Chang

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk Inc., United States
Dr. Chang has more than 20 years of experience in the development, regulation and quality of biologics and pharmaceuticals. As Vice President, Quality and Regulatory Compliance, Novo Nordisk, he is responsible for external affairs, providing strategic advice and solutions for quality... Read More →
avatar for Olivia Shopshear

Olivia Shopshear

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Olivia is a senior director of Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). Olivia has extensive multi-disciplinary program management and regulatory policy experience in the biopharmaceutical and biodefense industries, ranging... Read More →
avatar for Mark Birse

Mark Birse

Vice President, Technical, Parexel International, United Kingdom
Mark is a strategically orientated regulatory compliance professional, with a career spanning the regulation of pharmaceuticals and medical devices. Prior to joining Parexel, Mark previously worked at the MHRA where held a number of leadership roles, including Deputy Director Inspection... Read More →
avatar for Stephan Roenninger

Stephan Roenninger

Director, Quality External Affairs, Amgen (Europe) GmbH, Switzerland
Stephan Rönninger holds a PhD-engineering degree in organic chemistry from the TU Darmstadt, Germany, and was appointed as Adjunct Assistant Professor at GWU, Washington D.C. and is an Academic visiting expert of the National University of Singapore. He is in the Quality External... Read More →
AI

Andrew Idzior

Chemist and Interdisciplanary Scientist, OPMA, OPQ, CDER, FDA, United States
Andrew Idzior has worked at the FDA for over 10 years. He started as a laboratory chemist in the Detroit District laboratory analyzing food, drug, and cosmetic samples. He then became an investigator and inspected both domestic and foreign drug manufacturing facilities. Now, Andrew... Read More →

Wednesday June 30, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session