COURSE OBJECTIVES

This refresher course reinforces the essential Canadian Good Manufacturing Practices requirements. After completing this course, you will be able to recall and apply key regulations, maintain compliance in daily operations, and avoid common inspection findings.

COURSE SCOPE

This course covers the core elements of Canadian GMP under Part C, Division 2 of the Food and Drug Regulations, including GUI-0001, GUI-0036 (Annex 13), and GUI-0104. Topics include regulatory foundations, premises, equipment, personnel, sanitation, raw material testing, manufacturing control, quality control, packaging and finished product testing, records and samples, stability, sterile products, medical gases, and clinical trial materials.

TARGET AUDIENCE

This annual refresher course is intended for all personnel who have completed the full initial GMP training, including:

• Quality Assurance Personnel
• Quality Control Personnel (analysts, supervisors, managers)
• Manufacturing Personnel (production, packaging, labelling)
• Regulatory Affairs Professionals
• Validation Specialists
• Compliance Officers
• Internal and External Auditors
• Importers, Distributors, and Wholesalers of drugs
• Contract Manufacturing Organizations (CMOs)
• Consultants to the pharmaceutical industry
• Personnel holding a Drug Establishment Licence (DEL)
• Health Canada Inspectorate personnel (as reference)

CERTIFICATE DETAILS

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.