Information Technology systems that are deployed in the Life Science industry may be subjected to FDA regulations–specifically CFR Part 11– to assure a consistent level of safety during the development of drugs, therapies, and devices which are ultimately intended for human use. Failure to adhere to these guidelines could result in severe fines from the FDA, or worse, it could endanger the health and lives of patients.
CFR Part 11 is a set of guidelines also known as validation. The project manager who has a strong understanding of validation will run a more effective and efficient project!
This webinar was the second in a series on this topic in which we introduce more advanced concepts, scenarios, and industry trends for project managers in Life Sciences.
We were excited about the addition of Hitesh Bhatt as a featured guest, who shares his experience and knowledge of SaaS validation to provide Project Managers with the critical information needed for implementing SaaS systems. This was a very valuable discussion!
The webinar content is ideally suited for the project manager who wants to become an expert at managing validated projects. You can download the video now! Simply fill out the form on this page.
About our Hosts
With over 20 years experience working as an IT Project Manager in Government, High Tech, Finance, and Life Science industries and overs 10 years of working in Life Sciences as IT Program Manager, Kristen currently specializes in high-performance computing for Scientific Research for The BioTeam.
Ron has 30 years experience in Engineering, Operations, IT, and Consulting across many industries and domains. For the past 10 years, he’s worked in Life Sciences as Project & Program Manager. He currently serves as Vice President of Life Sciences Services for Hawkins Point Partners– a Strategic IT Solutions Provider.
Hitesh will be our featured guest, sharing his experience and knowledge of SaaS validation to provide Project Managers with the critical information needed for implementing SaaS systems. He has 18+ years working in the Life Sciences industry with extensive experience in all aspects of Quality and IT roles. He nows serves as Managing Director of IT Quality & Regulatory Compliance Services for Hawkins Point Partners, a Strategic IT Solutions Provider.
IT Validation 202 Webinar
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