The GMP Fast Track Freshers Training Programme is a useful training course for individuals either new to a healthcare manufacturing company or moving departments, to learn and understand more about Good Manufacturing Practice (GMP) and its application.
The first day of the programme is the Introducing GMP Training (1 Day) Course, building an understanding of GMP and its application.
The second day progresses to investigate electronic records and signature requirements for America and the EU. Important consideration is given in the use of best practice SOPs, and corresponding training and evaluation. An overview of the validation process and how it is implemented is described and explained.
The course enables learners to investigate the regulatory drive for implementing risk management (review of Q9 Guidance), including the FMEA risk assessment method and the importance of change control including related issues. Learners also apply their learning by reviewing real case studies where GMP non-compliance could occur, determining potential solutions to such situations. |