Current Topics on Management of GMP Data Integrity

Duration: 90 Minutes
Over 40 warning letters cited data integrity issues in 2016, and the trend has continued in 2017. This webinar gives an overview of the current regulatory climate regarding data integrity, including regulators' expectations for ensuring that the data lifecycle is integral. Highlights from the recent publications by FDA, MHRA, IPSE, and WHO will be discussed, as well as strategies for prevention, detection, and remediation of issues will be explained.
GMP Data Integrity
Instructor: Sarah Tanksley
Product ID: 509710
Objectives of the Presentation
  • Learn the meaning of data integrity and how it differs from data falsification
  • Learn the expectations for both paper and electronic records
  • Learn some of the highlights of the most recent publications from regulatory agencies worldwide regarding data integrity expectations
  • Review of some recent FDA warning letters citing data integrity issues, and what we can learn from the text
  • Strategies to detect and remediate data integrity breaches
  • Considerations for data governance systems
Why Should you Attend
The 2016 FDA Data Integrity Guidance for Industry states that they expect personnel to be trained on detecting data integrity issues as part of the routine GMP training program. This webinar meets this training objective.

Areas Covered
  • An overview of the US predicate regulations that encompass data integrity
  • Expectations for maintaining paper records
  • Expectations for maintaining electronic records
  • Reasons for the recent uptick in data integrity related findings
  • Consequences of data integrity issues
  • Tips for QA reviewers or auditors to find data integrity issues
  • An introduction to data governance planning
  • Data life cycle mapping and risk based approaches to data review
Who will Benefit
All personnel involved in the generation or review of GMP records, including QA professionals, laboratory personnel, those involved in batch review or release, internal and external auditors, site leadership, risk management professionals, regulatory compliance personnel, production employees and managers, QC chemists, supervisors and managers, R&D chemists, supervisors and managers.
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Sarah Tanksley has been consulting in the area of pharmaceutical quality and compliance since 2011. She has led several remediation projects involving breaches in data integrity and has led audits which have detected both gaps and falsified data. She regularly lectures on the topic of data integrity to audiences worldwide. Prior to consulting, she was a Consumer Safety Officer the Office of Compliance, Center for Biologic Evaluation and Research at the Food and Drug Administration, where she reviewed new applications for approval and conducted prior approval inspections as well as routine GMP inspections. Sarah joined the FDA after several years in the laboratory at the National Institutes of Allergy and Infectious Disease, National Institutes of Health. She has a Master's of Science in Biochemistry and Molecular Biology from Georgetown University, a Master's of Science in Regulatory Science from Johns Hopkins University, and a Bachelors degree in Biology from the College of William and Mary.
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