David Blewitt is the Vice President of Cloud Compliance at USDM Life Sciences.
David is an accomplished Life Sciences Regulatory and IS Compliance Professional with extensive hands-on and leadership experience in the Pharmaceutical, Medical Device, Biotech and Blood Management Industries, specifically in the fields of; Computer Systems Validation, Risk Management, Issue Investigation – Root Cause Analysis and Remediation, Quality Assurance, Software Development Lifecycle, Lean IS Compliance Enhancement Initiatives, Business Analysis, Product Lifecycle Management and Systems/Process analysis with 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 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.