01
Session 1
Overview of GMDP Regulations (Medicines Law) & Importance of GMDP
02
Session 2
Introduction to GxP
03
Session 3
Human Medicines Regulation 2012
04
Session 4
EU laws and regulations
05
Session 5
GMP Structure & The Orange Guide
06
Session 6
Regulatory Agencies in Pharmaceutical Manufacturing
07
Session 7
Veterinary Medicines Legislation
08
Session 8
PIC/S –Pharmaceutical Inspection Convention and Co-Operation Scheme
09
Session 9
International Conference on Harmonisation of Technical Requirements
10
Session 10
Grant and Supervision of Licences
11
Session 11
What are the Pharmacopoeias
12
Session 12
GMP vs ISO
13
Session 13
Control of Product Lifecycles
14
Session 14
Controlled Drugs
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
