The quality, efficacy, and safety of medicinal products are assured by employing guidelines appropriate for each stage of the manufacturing and distribution process. Current Good Practices (cGxP) is a set of such guidelines which have been put together by regulatory agencies such as WHO, EU, FDA, etc. This course helps participants understand the concept of cGxP, highlighting the advantage that it presents. You will also learn about non-compliance which is a major threat to the production of high-quality products. Finally, you get to see how regulatory bodies help to enforce these guidelines with inspections, audits, sanctions, and denial of marketing authorization.
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: An Understanding to cGxP
Lesson 2: Regulatory bodies for Pharmaceutical Industry
Lesson 3: Non-Compliance: A Major Obstacle
Lesson 4: Meeting and Maintaining the Standards Required for Good Practices in Pharma
Lesson 5: The Impact of Covid-19 on Biologics Regulations
Lesson 6: Training in Good Data and Record Management
Lesson 7: Designing and Validating systems to Assure Data Quality and Reliability
Lesson 8: Data Life Cycle
Lesson 9: Implementation of cGxP