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