|
|
 |
Good Manufacturing Practice (GMP) Awareness Training for Pharmaceutical Industry
Understanding Regulatory and GMP Requirements for Pharmaceutical Companies
The course addresses the pharmaceutical product supply chains for human medicines, from the producers of raw materials to manufacturers of finished products.
The contents and the discussions will help each individual involved in GMP understand where their contribution fit into the GMP framework within an organization and how different departments function together with protecting quality, safety and efficacy of the pharmaceutical products as the responsibilities of all parties involved. Consequently, it helps the participants understand the reason for observing GMP rules and develop a positive attitude towards GMP.
Who should attend?
The course is designed for individuals of all levels within a Pharmaceutical Manufacturing Organization. QA, QC, Production as well as RA and General Management Positions will be able to better understand the issues at stake as per GMP requirements.
Course Outline
- Regulations in Europe
- Regulations in the USA
- Harmonised Regulations
- GMP in Manufacturing
- GMP in Quality Control
- Documentation (Report & Record)
- Qualification and Validation
- Chang Management
- Self-Inspections
- Performance of Self Inspections
- GCP – Clinical Trials Introduction
- Test (M.C.)
|
