01
Session 1
Required GMP Documentation
02
Session 2
Generation and Control of Documentation
03
Session 3
Retention of Documents
04
Session 4
Good Documentation Practices
05
Session 5
Standard Operating Procedures (SOPs)
06
Session 6
Manufacturing Formula and Processing Instructions
07
Session 7
Specifications
08
Session 8
Batch Processing Record
09
Session 9
Batch Packaging Record
10
Session 10
Logbooks and Operating Procedures
11
Session 11
Managing PQS for GMP Documentation
12
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
