01
Session 1
Introduction to Drug Development and Regulatory Affairs
02
Session 2
The Drug Development Lifecycle
03
Session 3
Regulatory Frameworks and Authorities
04
Session 4
The Role of Regulatory Affairs Professionals
05
Session 5
Understanding Global and EU Regulatory Landscape
06
Session 6
Medicines Legislation in the EU and UK
07
Session 7
Thermal Mapping and Qualification of Storage Facilities and Distribution Vehicles
08
Session 8
Pest and Rodent Control in Pharmaceutical Warehouses
09
Session 9
Products Distribution and Freight Forwarding for FDA-Regulated Products
10
Session 10
ERP Systems and Compliance in Pharmaceutical Distribution
11
Session 11
Supplier and Customer Approval, and Vendor Management
12
Session 12
Handling Rejections, Disposal, and Segregation of Products
13
Session 13
Prevention and Management of Falsified Products in Distribution
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
