GMP for Drug Importers 2024: Deviation Investigations & Root Cause Analysis

Join us for an in-person training session on Good Manufacturing Practices (GMP) specifically designed for professionals in the drug importing industry. This session combines in-depth lectures with hands-on exercises to cover essential GMP concepts, focusing on deviation and root cause analysis through real-life case studies. Attendees will work with GMP Blue Books™ to assess quality risks and strengthen their understanding of compliance requirements. The training session also features an update on Health Canada's latest inspection trends and regulatory changes over the past year, helping participants stay current in a rapidly evolving regulatory landscape.

This training session is intended for intermediate to advanced professionals (not beginners) seeking GMP training specific to Canadian pharmaceutical importing.

• Practical insights into applying GMPs in your role
• Potential risks associated with non-compliance and how to avoid them
• The keys to operating in compliance with GMP standards
• Skills in deviation and root cause analysis, addressing common challenges
• Recent regulatory updates and industry trends

Part 1: GMP Fundamentals & Health Canada Inspection Trends

Part 2: GMP Principles

• 5Ps of GMP
• Deviation and Root Cause Analysis
• Case Studies / Facilitated Discussion

Part 3: Compliant Operations

• Risk Management
• Workshop Role Play

Flora Suen, Manager, GMP Consulting Services, Q&C Services

Flora Suen is a quality assurance professional within Q&C Services with over 15 years of experience in the pharmaceutical, medical device and biologics/cell therapies industries. Flora provides general GMP consulting guidance and oversight related to commercial operations and pre-commercial activities (e.g., clinical trial quality support). Flora has experience with managing quality departments, quality control, aseptic processing, continuous improvement initiatives, and quality management systems.

Host or Publisher Q&C Services