A 2 day course limited to a maximum of 4 delegates.

This course encompasses the legal accountabilities of the Responsible Pharmacist in Industry both in terms of the Pharmacy Act as well as the Medicines Act 101 with an emphasis on the GMP accountabilities under Act 101 Section 22C-Licensing.

The topics to be covered are:-

  • The Acts and Regulations
  • GMP Basics
  • The Quality Manual and Quality System
  • Job descriptions, training and personnel
  • Warehousing and storage
  • Validation requirements
  • Lot release
  • Annual Product Overview
  • Documentation
  • Audits
  • Packaging materials and advertising
  • Technical contracts
  • Risk Management
  • Product disposal and product returns
  • Deviations
  • Recalls, complaints and ADR’s