Making Data Integrity Integral to cGMP Training

The FDA clarified the role of data integrity in the guidance, Data Integrity and Compliance with cGMP, released April 15, 2016. Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates® Inc., creates an understanding of how to incorporate data integrity into cGMP training in a published article in PharmTech. Key learnings from the article include:


  • The role of data integrity and document handing as part of good documentation practice (GDP)
  • How GDP training fits into annual GMP training along with investigations / CAPA training
  • Tips on leveraging the tools already in your organization’s quality system to reinforce data integrity concepts throughout both the training and auditing processes

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