Training related to pharmaceutical quality system and GMP documentation.
1. SOP Management
- SOP on SOP (Preparation, approval, control, revision)
2. Qualification & Validation
- Equipment / Instrument / System Qualification (IQ, OQ, PQ)
- Process Validation
- Cleaning Validation
- Media Fill (Aseptic Process Simulation)
- Hold Time Study
- Product hold time
- Media hold time
- Culture hold time
- Water sample hold time
- Volumetric solution hold time
3. Technology & Process Management
- Technology Transfer
4. Data Governance
- Data Integrity
5. Quality Risk & Compliance
- Change Control
- Deviation & Investigation
- OOS (Out of Specification)
- OOT (Out of Trend)
6. Audit & Inspection Management
- Audit Handling
- Self-Inspection
- Vendor Audit
- Auditor Qualification
7. Product Quality & Lifecycle
- Stability Study
- Market Complaint Handling
- Labelling Procedure
8. Quality Agreements
- Handling of Technical/Quality Agreements
9. Quality Monitoring
- Quality Metrics / Quality Matrix
10. Aseptic Practices
- Aseptic Behaviour Training
Lessons:
