Name: GMP for Drug Importers 2024: Deviation Investigations & Root Cause Analysis
Start: 2024-12-04T09:30:00-05:00
End: 2024-12-04T14:00:00-05:00
Location: 2000 Argentia Road, Plaza 2, Suite 220, Mississauga, ON L5N 1V8 Canada

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

Join us for an in-person, advanced training session on GMPs specifically designed for professionals in the Canadian drug importing industry.
About this Event

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.

Instruction Level/Who Should Attend:

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

You Will Learn:

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

Agenda:

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

Speaker/Trainer:

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.