This course provides an overview of regulatory expectations for data integrity including USFDA, WHO and PIC/s as well as relevant case studies. It also includes an overview of data integrity in different phases of product lifecycle and data governance and a quality culture.
Subject area:
cGMP
Drug Products & APIs
Objectives (If applicable):
– Describe regulatory expectations for data integrity
– Identify and explain data integrity in different phases of product lifecycle
– Explain data governance as it relates to a quality culture
Target Audience (If applicable):
– CXO (CEO, MD, CSO, COO)
– Global Quality
– Regulatory Heads
– SBU Heads