01
Session 1
Overview of Complaint Handling and Quality Defects
02
Session 2
Responsibilities and Organisation in Complaint and Quality Defect Management
03
Session 3
Investigating Quality Defects and Implementing CAPAs
04
Session 4
Conducting a Quality Defect Investigation
05
Session 5
Procedures for Product Recalls
06
Session 6
Evaluating the Effectiveness of Recall Procedures
07
Session 7
Overview of Pharmacovigilance
08
Session 8
Post-Market Surveillance
09
Session 9
Regulatory Expectations
10
Session 10
Managing Change in Pharmacovigilance
11
Session 11
Database Management in Pharmacovigilance
12
Session 12
Ensuring Timeliness in Pharmacovigilance
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
