The FDA is reporting increasing violations involving data integrity. In response, they have issued a draft guidance document. In March of 2015, the MHRA in the UK released a similar document. In this webinar, you'll learn how to avoid a violation. The discussion will include:

  • What is ‘data integrity’?
  • How can we demonstrate data integrity?
  • Original records vs. true copies
  • Integrity of audit trails
  • Static vs dynamic data
  • Issues with shared logins
  • Electronic data as GxP data
  • Audit trail reviews
  • Recent examples of FDA findings involving data integrity violations
  • Plus, live Q & A session

About the Presenter:

Diane Gleinser

Vice President of Life Science Solutions Diane has more than 29 years of experience in the life science industries. As a member of the senior management team at USDM Life Sciences, Diane leads a highly skilled team of implementation and compliance engineers and was instrumental in establishing USDM's Regulatory Compliance focus.

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