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Current Topics on Management of GMP Data Integrity - Webinar

  • ID: 4335808
  • Webinar
  • August 2017
  • Region: Global
  • 90 Minutes
  • Online Compliance Panel
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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.

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
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  • Sarah Tanksley Sarah Tanksley,

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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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