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Implement a Holistic Data Integrity Assurance Plan

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Implement a Holistic Data Integrity Assurance Plan

  • Instructor: Chinmoy Roy

  • Duration: 0 Min

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Business-Coordination

 

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While Data Integrity continues to occupy the top spot in C-suite issues, issuance of 483 and Warning Letters continues unabated. The prime cause for this is the inability of companies to address Data Integrity holistically. No longer can companies afford to view this issue as confined to a few areas of their operation. Instead, it needs to be viewed as a process-centric issue that spans the realm from data creation to data retirement as the data progresses from its point of creation to the point of its use and ultimate storage. Consequently, issues such as data provenance, Data Integrity maturity of the enterprise etc. are emerging as modern Data Integrity related issues. The objective of this webinar is to provide attendees with a window into the issues and challenges of implementing a holistic Data Integrity program at either the enterprise or business unit or department level.

 

Top 7 Reasons to Attend

  1. Review a process-centric approach from data creation to retirement
  2. Discover how auditors audit
  3. Understand modern issues such as provenance and maturity
  4. Learn a “least burdensome approach” program and why it’s a good first step
  5. Discover the critical incremental steps to design and implement a successful program
  6. Know how to monitor the effectiveness of the program
  7. Review 483/Warning Letter trends of the past 6 months

Chinmoy Roy

Chinmoy Roy, CSV and Data Integrity SME, retiree Genentech Inc.

Chinmoy Roy is a seasoned life sciences professional with over 38 years of industry experience. Mr. Roy’s extensive implementation experience in engineering, CSV, data integrity and IT compliance provides the foundation for my consulting and training services. While at Genentech, he was the principal technical lead for several engineering teams. These teams were engaged in the design, commissioning, validation and obtaining USFDA certification for IT and manufacturing IT systems for two paperless biologics manufacturing facilities totaling over a billion dollars. These systems were compliant with 21 CFR Part 11, and ISA’s S88 and S95 standards.

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