Laboratory Excellence and AccreditationPharmaceutical Quality Control and Good Manufacturing Practice
Pharmaceutical quality is judged on whether the manufacturer can demonstrate control, not on whether a batch happened to pass, which is why documentation carries as much weight as the analysis itself. This course covers both. Delegates work through the good manufacturing practice framework and the quality system behind it, premises, equipment and the qualification that must precede use, and documentation including batch records and the data integrity expectations now central to inspection. Analytical testing of raw materials, in process samples and finished product is covered. Stability testing and shelf life determination follow. Out of specification investigation is treated in detail, since how one is handled is itself an inspection finding. The course closes on deviations, change control and inspection readiness.
Course objectives
- Describe the good manufacturing practice framework and quality system
- Qualify premises and equipment before use
- Maintain batch documentation to data integrity expectations
- Test raw materials, in process samples and finished product
- Design stability studies and determine shelf life
- Investigate an out of specification result correctly
- Manage deviations, change control and inspection readiness
Who should attend
- Pharmaceutical quality control analysts
- Quality assurance and compliance staff
- Production supervisors in pharmaceutical manufacturing
- Regulatory affairs personnel
- Inspectors and auditors of manufacturing sites
Course outline
- 01Demonstrating control, not passing a batch
- 02The framework and quality system
- 03Premises, equipment and qualification
- 04Documentation and data integrity
- 05Raw material and in process testing
- 06Finished product testing and release
- 07Stability testing and shelf life
- 08Out of specification investigation, deviations and inspection
Scheduled sessions
| Dates | Venue | Format | Price | Register |
|---|---|---|---|---|
| 16 to 20 November 2026 | Harare, Zimbabwe | Classroom | USD 1,325 per delegate | Register Now |
| 18 to 22 January 2027 | Online | Online | R8,500 per delegate | Register Now |
| 1 to 5 March 2027 | Johannesburg, South Africa | Classroom | R19,950 per delegate | Register Now |
| 15 to 19 March 2027 | Nairobi, Kenya | Classroom | USD 1,325 per delegate | Register Now |
| 22 to 26 March 2027 | Dar es Salaam, Tanzania | Classroom | USD 1,325 per delegate | Register Now |