Gain a recognized and traceable certificate after completing the course :
All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.
As much as GMP is important for drugs that are approved to market by the FDA/EMA, it is equally pivotal for investigational medicinal products that are still undergoing clinical trials. Understanding and applying current GMP requirements to practice while manufacturing clinical trial material ensures that the investigational drugs and medicinal products are consistently produced under stringent quality control activities.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Quality Management of IMPs
Lesson 2: Quality Risk Management
Lesson 3: Personnel Management
Lesson 4: Documentation of IMPs
Lesson 6: Production for Clinical Trials Manufacture
Lesson 7: Qualification and validation
Lesson 8: Recalls and market returns
Lesson 8: Shipping
Lesson 9: Destruction