David Blewitt is the Vice President of Cloud Compliance at USDM Life Sciences
David is an accomplished life science regulatory and IS compliance professional with over 25 years of experience in the pharmaceutical, medical device, biotech, and blood management industries, specifically in the fields of; computer systems validation, risk management, quality assurance, software development, product lifecycle management, and compliance roadmap development.
He is an acknowledged expert on a wide range of regulatory predicate rules and guidance including:
- 21 CFR Parts: 11, 203, 210, 211, 801, 803, 820 and 821
- ICH Q7
- GAMP 5
Over the past decade, David’s engagements have been increasingly aligned with the validation and assurance of cloud systems and applications, including both standard and custom solutions for patient case management, sample management and tracking, content management and collaboration, adverse event case assignment systems and MHRA dispositioning systems coming under 21CFR Parts 203 (PMDA) and Part 11.