Foundation Module Assignment
During this short foundation course you have touched upon a range of 25-topics across 5-major areas which have been chosen for their relevance to manufacturing safe and effective medicines and medical devices.
Your end-of-module assignment is to write a 2-3 page essay (700 to 1,000 words) to clearly demonstrate your Knowledge and Understanding of the Quality Culture necessary to work in a GMP regulated manufacturing environment.
It needs to cover the following 5-areas (about ½ page on each):
Structure your essay by writing a short paragraph on any 2-topics from each of these 5-areas as detailed below:
Session 1 – Quality Management Requirements for Good Manufacturing Practices (GMP)
Session 2 – Process and Cleaning Validation
Session 3 – Quality Risk Management(QRM)
Session 4 – Key Manufacturing Technologies
Session 5 – Clean Air & Purified Water Systems