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Session 3 Track A: Virtual Good Manufacturing Practices (GMP) Inspections
Session Chair(s)
Yatika Kohli, MBA
Chief Compliance and Strategy Officer, NoNO Inc, Canada
Kristin Willemsen, MS
Vice President, Scientific & Regulatory Affairs, Food, Health & Consumer Products of Canada, Canada
During COVID-19, Health Canada has made a variety of changes to the regulatory approval process. These changes include conducting remote (virtual) evaluations in lieu of on-site inspections and issuing electronic licenses, replacing the traditional paper-based license. This session will include a presentation from Health Canada with updates on the recent changes and practices and presentations from industry with their experience, challenges and practices for preparing and conduct of virtual GMP inspections.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand Health Canada’s current approach for Virtual inspections
- Gain awareness of the challenges of and preparing for and conduct of remote evaluations
- List the Do’s and Don’ts of preparing for regulatory inspection- especially in a virtual environment
Speaker(s)
Kim Godard, PhD
Director, Health Product (Drug) Inspection and Licensing, Health Canada, Canada
Drug Product Compliance and Enforcement Post Pandemic
Melanie Bhangoo, MS
Manager, GMP Inspection Central, Health Canada, Canada
Drug Product Compliance and Enforcement Post Pandemic
Trevor Aldridge
Senior Director, Quality and Compliance, Brevitas Consulting, Inc., Canada
Considerations for Preparing for a Virtual Insection
Michael Schunk, DVM
Principal, Michael Schunk Biologics Consulting, Canada
Preparing for a Pre-approval Inspection – A Case Study