Who will the course benefit?
Our GMP course is aimed principally at personnel new to Supervisory and Management roles who need a detailed explanation of GMP, its requirements and how it works. The GMP course will also be of benefit for anyone new to pharmaceuticals who have had no significant GMP training previously.Course overview:
Delegates will learn about GMP and how it is applied in a manufacturing operation. Delegates will leave the GMP course with a clear understanding of the requirements of EU GMP and an appreciation of USA GMP.For a more in-depth review of GMP our 3-day Advanced GMP course may be of interest - see our website for details.
A short online refresher/compliance programme costing from £95 per delegate is also available with versions for Packaging, Warehouse, Laboratory and Manufacturing personnel available – for more details see our website
Course contents:
- An introduction to GMP
- The history of GMP
- Why do we have GMP in pharmaceuticals?
- Licences for medicines and GMP enforcement
- GMP in the Product Lifecycle
- The legal status of GMP
- The structure of the EU Guide to GMP / The UK Orange Guide
- GMP in the USA
- Current and future issues in GMP
- Duties of key personnel and departments
- The role of Production, Quality Control (QC), Quality Assurance (QA) and the Qualified Person (QP)
- The principle GMP requirements for documentation and records
- GMP in the workplace
- GMP and documentation
- People, training and hygiene
- Data integrity
- Dealing with problems and root-cause analysis
