QA302 Current Good Manufacturing Practices (cGMP) — Quality Systems Part 3

This course expands on GMP Part 1 and Part 2 and examines global GMP and other international regulatory guidelines, policies, and expectations including Health Canada, EMA, and ICH. Learners will review cGMP requirements on manufacturing control of active pharmaceutical ingredients (API), excipients, and finished products. Technical aspects of pharmaceutical manufacturing control, labeling, and distribution associated with cGMP regulations are analyzed and covered in detail.

Learners will be provided tools to contribute and run a compliant pharmaceutical quality system under cGMP guidelines.

Learning Points:

• Key information on Annual Product Quality Reviews (APQR)
• Understanding Manufacturing Controls for APIs, Excipients, and Finished Drug Products
• Production Controls and Validation of Processes
• Packaging, Labeling, and Distribution control
• cGMP for Sterile Production
• Knowledge of Health Canada, EMA, ICH, WHO, ISO, SUPAC, etc.
• The Role, Scope, and Application of International Conference on Harmonization (ICH)
• Manufacturing Control for Drug Products