Proposed Data Integrity Guidelines

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 In response, they have issued a draft guidance document.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 85x105 rightDiane Gleinser has more than 27 years of experience in life science based industries, encompassing quality assurance, quality control, validation and regulatory compliance for research and development, clinical affairs, manufacturing and packaging, laboratory setup and analysis, and auditing under cGMP, cGLP and cGCP regulations and 21 CFR Part 11.  Diane is also certified in pharmaceutical and medical device law.

 

 

 

Register Now

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials