Ensuring Data Integrity - Trends, Challenges and Best Practices

Learning Level: Basic/Intermediate
Time: 1100 - 1200 ET 
Session Length: 1 hour

With the growing use of computerized systems across the product lifecycle, ensuring data integrity is becoming more challenging in an increasingly complex pharmaceutical and medical device industry. Furthermore, with the implementation and use of AI tools rising data integrity issues have been observed by the FDA, WHO, MHRA and other regulatory agencies in spite of the guidance’s that have been provided… Leaving more questions than answers for organizations.

This webinar presents why this trend is happening and suggests that getting back to the basics is the key to overcoming data integrity challenges. Data integrity experts from Catalent, Abbott, GSK and Verista assess the prevalence and trends of recent Data Integrity violations; identify reasons why companies commit DI violations; discuss the challenges of FDA and EU guidance on Data Integrity and AI; and finally explore best practice solutions which can promote Data Integrity.

Learning Objectives

  • Understand the current regulatory position on data integrity
  • How to assess your current state and how to get to a compliant state
  • How to assess if you’re running out of control: verification, validation and audits
  • Learn about best practice approaches to improve data integrity in commercial, laboratory and manufacturing environments
  • Sticking to the basics of ALCOA-Plus
  • AI trends, pros and cons, challenges, fears, and cybersecurity

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Sponsored By: Virista horizon


Charles Yardley
Head of Technology Solutions
Jeff Onis
Global IT Data Integrity Manager
Catalent Pharma Solutions
James Li
ANQA Director of Validation & Risk Management
Don Brown
Director of Infrastructure and Cybersecurity
Eric Watkins
Senior Delivery Manager