Learn about Health Canada Medical Devices Regulations and Medical Devices Licensing and Quality Assurance requirements.
- Professor: Pr. Peivand Pirouzi
Program in Quality Assurance Management and Good Manufacturing Practice (ICH-GMP).
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 the Guidance on writing a product Quality Review for QA