01
Session 1
Introduction to Outsourced Activities and Contract Giver Responsibilities
02
Session 2
Responsibilities of the Contract Giver
03
Session 3
Responsibilities of the Contract Acceptor
04
Session 4
The Contract: Content and Structure
05
Session 5
Quality Management in Outsourced Activities
06
Session 6
Quality Risk Management
07
Session 7
Managing Challenges in Outsourced Activities
08
Session 8
Technical Quality Agreements
09
Session 9
Service Level Agreements
10
Session 10
Technical Agreements with QP
11
Session 11
When to raise Change Control
12
Session 12
API Sourcing
13
Session 13
Supplier Qualification
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
