Documentation
Session 1
Required GMP Documentation
Session 2
Generation and Control of Documentation
Session 3
Retention of Documents
Session 4
Good Documentation Practices
Session 5
Standard Operating Procedures (SOPs)
Session 6
Manufacturing Formula and Processing Instructions
Session 7
Specifications
Session 8
Batch Processing Record
Session 9
Batch Packaging Record
Session 10
Logbooks and Operating Procedures
Session 11
Managing PQS for GMP Documentation
Session 12
Data Integrity
Our Courses
- Introduction to GMDP Regulations and Importance of GMDP
- Pharmaceutical Quality System (PQS)
- Personnel
- Premises and Equipments
- Documentation
- Production
- Quality Control
- Outsource Activities
- Complaints, Quality Defects, and Product Recalls
- Self-Inspection and Audit
- Good Distribution Practice (cGDP)
- Regulatory Affairs & Regulatory Submissions
