01
Session 1
Identifying Production Steps
02
Session 2
Setting Specifications and Bio-Batch Activities
03
Session 3
Handling Materials and Products
04
Session 4
Labelling and Documentation in Production
05
Session 5
Yield and reconciliation
06
Session 6
Prevention of Cross-Contamination- Gowning, Sanitization and hygiene, Environmental monitoring and control, Cleaning Validation
07
Session 7
Validation in Production
08
Session 8
Good Engineering Practices
09
Session 9
Packaging Operations
10
Session 10
Printed material control
11
Session 11
Warehouse Operations
12
Session 12
Handling Rejected, Recovered, and Returned Materials
13
Session 13
Finished Products and Product Shortage Management
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
