Premises-and-Equipments
Session 1
General Requirements for Premises
Session 2
Production Area Design and Management
Session 3
Storage Area Requirements
Session 4
Quality Control Area Design
Session 5
Ancillary Areas Management
Session 6
Cross-Contamination Prevention Strategies
Session 7
General Requirements for Equipment
Session 8
Equipment Cleaning and Maintenance
Session 9
Validation, Qualification, Calibration and Verification of Equipment
Session 10
Management of Fixed Pipework and Water Systems
Session 11
Equipment Risk Management
Session 12
Documentation and Record-Keeping
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
