Automating CSA Risk Management: Perspectives from BD

BD’s Roy Devine and Frank Meledandri Sr will share their experiences in driving a risk-based CSA methodology. In addition to touching on procedural and cultural change, they will share aspects of their business case and approach to automating with Polarion CSA, a paperless “best-in-class” data-centric CSA Risk Management solution. Moderated by Compliance Group’s Jason Spiegler, who created and co-leads the FDA-Industry CSA team (FICSA), the group will also provide lessons learned and advice to participants looking to transform and automate CSA Risk Management.

As BD is one of the world’s largest global medical technology companies focused on improving medical discovery, diagnostics, and the delivery of care, you won’t want to miss this!

SPEAKERS

Frank Meledandri Sr.

Associate Director, Quality Strategy – Quality Management, BD

Roy Devine

GPO Computer System Validation, BD

Roy is the (GPO-CSV) Global Process Owner for Computer systems validation; GPO (e-systems, e-data management and cybersecurity) Heads validation and compliance team as part of Global IT.

AT BD, Roy is 3 years into a 5-year Enterprise-wide initiative to harmonize and align QMS systems, focusing on rationalizing 9 policies & 65+ procedures for CSV into 1 Policy and 4 procedures as the foundation of a simplified Risk based approach for CSV.

Prior to joining BD in July, 2016, Roy previously served 9 years as the Global Consulting Practice lead for 2 international consulting firms, before that he spent 12 years as an independent consultant to Tier 1 pharma companies in Advanced Clinical R&D and Safety information systems. Key experiences included. leading Clinical, Pharmacovigilance and Reg affairs strategic program development, eTMF development, Regulatory Intelligent services. He started his career in Merck as Development Architect for remote data capture. Roy earned a BS degree in Information Decisions Systems from CMU in Pittsburg.

MODERATOR

Jason Spiegler

Senior Vice President of Strategy, Sales, and Marketing, Compliance Group

Jason Spiegler serves as Senior Vice President of Strategy and Customer Experience. Spiegler is responsible for the company’s strategy development, and leads the sales, marketing, and organizational change management organizations across their staffing, strategic consulting, and technology solutions business units.

Prior to CG, Spiegler was with Siemens Digital Industries Software, where he led many collaborative initiatives with the FDA and customers, helping to remove barriers and increase the velocity of innovation and improvement for the industry. Spiegler co-created the FDA – Industry CSA team (FICSA) in 2016 and led Advanced Manufacturing Digital Thread projects with FDA CDRH and FDA OCET (https://www.fda.gov/emergency-preparedness-and-response/ocet-advanced-manufacturing/smart-design-and-manufacturing-pilot).

Prior to Siemens, Spiegler held Quality Management positions with Johnson and Johnson and several medical device start-up companies. Spiegler has more than 25 years of experience in Quality, Business Development, and Sales Management roles within the Life Sciences and Technology industries.

Spiegler earned his Bachelor of Science degree in Mechanical Engineering with a concentration in Engineering Leadership Development from The Pennsylvania State University, and an Executive Master of Business Administration degree from Baruch College. Jason previously served on the ASQ National Board of Directors and co-created the ASQ Emerging Quality Leaders Program.

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