The Introducing GMP Training Course is a foundation or refresher course useful for individuals who need to understand what Good Manufacturing Practice (GMP) means for healthcare manufacturers, and subsequently their suppliers.
The course takes into consideration how GMP is applied throughout companies, by viewing the organisation using the categories: People, Procedures and Documentation, Products and Components, and Production Areas and Equipment.
Other key parts of the course include a review of the industry regulators, their requirements and how they regulate. Also investigated are the consequences of non-compliance, and people behaviours and habits, to encourage GMP in operations.
The course attracts a mix of learners from different industries and mixed disciplines, including pharmaceutical and medical device manufacturers, wholesale distributors, and suppliers including OEMs.
Understand the need for GMP
What is GMP?
GMP and its link with Quality Assurance and Quality Control
Define the GMP guidelines and how agencies enforce them
What are the relevant regulations?
How the main regulatory agencies audit and enforce them
Investigate the 4 Ps
People - adequacy, experience, training and the role of the Qualified / Responsible Person
Procedures and Documentation - from the completion of SOPs to in-process controls
Production Areas and Equipment - premises, layouts and considerations
Products and Components - incoming, handling, storage, packaging, labelling and non-conforming products
Identify potential GMP violations and their consequences
Use interactive case studies to analyse scenarios
Examine real reported incidents
Determine behaviours that improve GMP
Plan for workplace improvements