EDRA 512

This course introduces the role and major elements of pharmaceutical quality, the impact of management practices, and quality management throughout the product life cycle. It will include the basic principles and practices of Quality Management (QM), Quality Assurance (QA), Quality Control (QC), and the use of robust Quality Systems in the pharmaceutical industry. Students will also be familiarized with the use of techniques such as Risk Management, Quality-by-Design (QbD), and the Pharmaceutical Quality System (PQS) approach.

 

It will ensure a clear understanding of concepts like GMP laws and their application in relevance to quality and extend to other GXP levels like GLP, GDP, GSP, GCP, and so forth. Additionally, it will explain the quality mindset and culture and its impact on pharmaceutical organizations