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Session 3 Track A: Virtual Good Manufacturing Practices (GMP) Inspections
Session Chair(s)
Yatika Kohli, PHD, 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)
Drug Product Compliance and Enforcement Post Pandemic
Kim Godard, PHD
Health Canada, Canada
Director, Health Product (Drug) Inspection and Licensing
Drug Product Compliance and Enforcement Post Pandemic
Melanie Bhangoo, MS
Health Canada, Canada
Manager, GMP Inspection Central
Considerations for Preparing for a Virtual Insection
Trevor Aldridge
Brevitas Consulting, Inc., Canada
Senior Director, Quality and Compliance
Preparing for a Pre-approval Inspection – A Case Study
Michael Schunk, DVM
Michael Schunk Biologics Consulting, Canada
Principal