Trends in Health Canada InspectionsDay & Time:
October 28, 1:30PM - 5:00PMInstructor(s):
Director, Regulatory Affairs and Quality Assurance
AstraZeneca, Inc., Canada
Sr Corporate Regulatory Compliance & Enforcement Advisor
Health Canada, Canada
Linda Jack, PhD
Director, Regulatory Affairs & Quality Management
Hoffmann-LaRoche Limited, Canada
Senior Compliance Specialist, Drug GMP Inspection Unit
Health Canada, CanadaDescription:
This tutorial will focus on recent trends in Health Canada Inspections from the perspective of the Inspectorate and the Industry it regulates.
Following an overview of the Inspectorate and the Inspection strategy for drugs, biologics and medical devices, the Inspectorate and Industry will discuss emerging trends.
For GMP and medical devices inspections, the Inspectorate will present a summary of top observations, including examples on GMP, medical devices and clinical trial inspections. Industry speakers will discuss how recent inspection observations have changed their operational practices in Canada and globally.
Additionally, HPFBI will provide Industry with advice on areas considered “grey space.”
Follow this link for more information.
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At the conclusion of this tutorial, participants should be able to:
- Discuss the HPFBI’s current mandate and operations for GMP oversight in the areas of drugs and medical device manufacturing, importing and distribution.
- Describe how Industry should prepare for drug, biologics and medical device inspections by gaining knowledge of recent inspection findings and issues and how some companies have adapted operations to respond.
- Apply advice from the Inspectorate on managing topics that drug and medical device manufacturers, importers and distributors seek clarity on.