Philip Jarvis, Director, integrated C&Q and digital validation Strategy, Veqtor solutions.

  • How digital validation tools are enabling validation 4.0
    • Risk based data integrity processes (importance of data mapping and criticality of data)
    • Building in Data integrity by design into digital validation systems
    • Data integrity guidance watchouts – Bring paper into the digital world compliantly and defining “true copy” practices
  • How to create the digital workforce of the future
    • Enabling digital validation education
  • AI , machine learning ,and system integration – How can the be harnessed to enable validation 4.0 and a digital validation ecosystem ?
    • Differences between AI /Machine learning – how do they impact validation strategy
    • AI how can it be used to enable validation 4.0 and dynamic documentation
      • Live example of tool
    • Interfacing key data systems for digital validation ,and creation of data flowsDiscussion on the changing world of validation (pharma 4.0 / validation 4.0)  and the hot topics of the moment . How do we create a digital validation ecosystem ,create data integrity by design, and harness digital validation tools and emerging technologies such as API’s /AI /ML  to create dynamic validation data to enable validation 4.0 principles.

Takeaway Tools

  • Scenarios of how to treat static and dynamic data based on risk for “true copy”
  • Demonstration of AI LLM tool for creation of digital validation documentation

SPEAKERS

Philip Jarvis

Director Integrated C&Q and Paperless Strategy, Veqtor Solutions


Mr. Jarvis is an experienced team leader with over 20 years of experience in all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device / pharmaceutical / and biologic industries.

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