David Blewitt

Vice President of Cloud Compliance , USDM

David Blewitt Vice President of Cloud Compliance David is an accomplished life sciences regulatory and IS compliance professional with more than 25 years of experience in the pharma, medical device, biotech, and blood management industries, specifically in the fields of computer systems validation, risk management, quality assurance, software development, product life cycle management, and compliance roadmap development. David 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 focused on the validation and assurance of cGxP 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. David's Recently Published Resources Video: Your Compliance and Technology Today On-Demand Webinar: Virtual Audits and Inspections – Best Practices for Life Sciences Companies On-Demand Webinar: An Introduction to Computer System Validation Blog: Cloud 101: Part 1 – Cloud Service Models White Paper: Regulatory Risk Reduction in the Cloud: Why Cloud Systems Are Safer Than On-Premise Systems

Session Track:

Wednesday, May 17 11:10 AM - 11:40 AM 210 C

AR1545B - Improve Pharmaceutical Manufacturing Quality with Augmented Reality

A highly specialized workforce is a cornerstone of a pharmaceutical business. It’s also a substantial source of escalating costs and pressure. The skills gap, traditional paper-based SOPs, and increasing complexity of the drug production process are causing global workforce challenges. Pharma organizations using visual augmented reality (AR) work instructions to enable greater workforce accuracy and productivity can realize substantial bottom-line savings, which will grow significantly as the solution scales. AR helps pharma organizations address the skills gap, reduce errors, and address challenges associated with employee training by creating clear, easy-to-follow, contextual SOPs and instructions.

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