This course covers the following topics:
- Principle and overview of the Total Quality System (TQS)
- Development, content and implementation of TQS
- Heath Canada GMP Guidance
- Health Canada Cannabis Regulations
- What is GPP?
- Why is GPP important?
- Official GPP directives in Health Canada Cannabis Regulations
- The basic requirements of Good Production Practice
- SOP writing
- Generation and control of documentation
- Types of documents and specifications
- Change Control
- Employee Training Management
- Inventory and Storage Management
- Complaint Management
- Recall Management
- Audit Management
- Investigation and Root Cause Analysis
- Corrective and Preventive Actions
- Sanitation Management and Employee Hygiene
- Document and Data Management
- Background and duties of the Qualified person
- Duties of the Head of the production department
- Duties of the Head of quality control
- Premises and Equipment
- Reporting of Adverse events to Health Canada
- Professor: System Administrator