01
Session 1
Introduction to the Pharmaceutical Quality System (PQS)
02
Session 2
Key Components of Quality Management
03
Session 3
Designing and Implementing a Robust Pharmaceutical Quality System
04
Session 4
Roles and Responsibilities in PQS management
05
Session 5
Product Realization and Lifecycle Management
06
Session 6
Change Management System
07
Session 7
Errors, Deviation and CAPA Management System
08
Session 8
Quality Risk Management (QRM) & Knowledge Management
09
Session 9
Continuous Improvement Strategies
10
Session 10
Ongoing Monitoring and Senior Management Review
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