Duration: 1.5 days
Delivered in partnership with RSSL this interactive 1½ day course examines why we have Good Manufacturing Practice (GMP), its legal status and the key GMP issues surrounding pharmaceutical manufacture such as documentation, training, and facilities. Delegates will be introduced to the EU Guide to GMP and considers its implementation in the modern pharmaceutical regulatory environment.
The course programme will include expectations of medicines, the purpose of GMP, pharmaceutical quality systems, the EU guide to GMP and the US CFRs, roles of key personnel and their departments, documentation requirements, GMP in the warehouse and dispensary, GMP in production and packaging, people and training, and an introduction to deviations.
o Expectations of medicines
o Why do we have GMP? What’s involved?
o Sampling exercise
o Pharmaceutical quality system
o The Orange Guide to GMP
o Annex II: Biological substances and products
o Personnel responsibilities
o Documentation - what are the GMP requirements?
o Exercise: Documentation
o GMP in the warehouse and dispensary
o GMP in production
o GMP in packaging
o Exercise: Out of calibration
o What have we learned?
o Batch Deviation Exercise – delegates to apply their understanding of GMP compliance to a mock deviation investigation - using example data and batch manufacturing records. Delegates will have the chance to apply their problem-solving skills to a scenario they may encounter in the workplace
Who should attend:
More dates coming soon
For enquiries and details of the full agenda please email CPDNHC@tees.ac.uk