Production
Session 1
Identifying Production Steps
Session 2
Setting Specifications and Bio-Batch Activities
Session 3
Handling Materials and Products
Session 4
Labelling and Documentation in Production
Session 5
Yield and reconciliation
Session 6
Prevention of Cross-Contamination- Gowning, Sanitization and hygiene, Environmental monitoring and control, Cleaning Validation
Session 7
Validation in Production
Session 8
Good Engineering Practices
Session 9
Packaging Operations
Session 10
Printed material control
Session 11
Warehouse Operations
Session 12
Handling Rejected, Recovered, and Returned Materials
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
