Learn about Health Canada Medical Devices Regulations and Medical Devices Licensing and Quality Assurance requirements.

Program in Quality Assurance Management and Good Manufacturing Practice (ICH-GMP).

Program Outline:

1- Introduction to Quality Management Systems and Quality Assurance and Good Manufacturing Practices (ICH-GMP) 

2- Essential Elements of GMP & Technical and Regulatory documents for QA: (SOP, OOS, Deviation and Validation Reports, Change Control, and Product Quality Review)

3- Audit and Inspection management

4- Handling Product Complaints and Recalls


Learn how to write SOPs (Standard Operating  Procedures) and about various other technical documents.

Learn about GMP validation requirements for QA

Learn about the Guidance on writing a product Quality Review for QA