Presented by: Rob Eleuterio & Rick Dursch

Moderated by: Khaled Moussally

  • Because of the rise of data theft and ransomware, data integrity shouldn’t (and can’t) be handled internally alone. Data integrity needs to focus not just on information security, but also eliminating bias in the process ideally with 3rd party input.
  • Data is one of the most important assets companies have. In order to protect it, companies need specialists that handle this with a complete understanding of the regulations and requirements set forth by the FDA.
  •  Compliance with 21 cfr part 11 and how that often doesn’t align with what an OEM installation package is going to provide you COTS.

By attending you can expect to learn the following:

  • Reduction in lost man hours
  • Protection of intellectual property
  • Preventing negative press
  • Ensuring patient safety and market competitiveness
  • Ensuring audit inspection readines

Takeaway tools:

  • Gap analysis, FDA issues, new business
REGISTER

SPEAKERS

Rob Eleuterio

Senior Manager, Validation, Compliance Group 

Robert has 10+ years of experience in quality systems, project coordination, and laboratory operations in the biotechnical, pharmaceutical, and medical device industries including experience in external quality, vendor communication, gene therapy/RNA therapy /Vaccines and emerging personalized medicine pharma. Extensive experience in laboratory design and validation from medical device quality and R&D operations, pharmaceutical QA/QC, and (petro)chemical. Roles include drafting of significant deliverables, test executions, design verification, QMS managements, complaint handling, and cross-functional team environments. Experience with Analytical Instrument Qualification, laboratory compliance activities including auditing and ownership of instrumentation and test method validation per USP and CFR requirements. Experience with laboratory and mfg investigations, quality trending, OOS and OOT, investigations, and CAPA activities. Ability and familiarity to perform instrument risk classification, FMEA’s, quality trending of data output during validation activities, and build USR’s from stakeholders needs.

Rick Dursch

Director of Data Integrity and Software Validation, Compliance Group 

Khaled Moussally
Executive Vice President, Corporate Development & Operations, Compliance Group

Khaled is a seasoned Quality & Compliance executive with over 27 years of experience spanning IT, manufacturing, and quality within the corporate sector of the Life Sciences industry. His journey has evolved from corporate roles to a consulting position, where he aims to revolutionize Quality & Compliance through his extensive background working with regulatory bodies. As an active contributor to the MDIC “Case for Quality Initiatives” and a member of the “FDA – Industry CSA team,” Khaled plays a pivotal role in shaping the FDA draft guidance on “Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software.” He also serves on the “ISPE GAMP America Steering Committee” and has gained recognition for his collaborative presentations with the FDA at various industry conferences. These presentations focus on the application of the CSA concept to not only shorten CSV cycle times but also to enhance overall quality, marking him as a leading figure in driving forward-thinking approaches in the field.

Contact Us

Refund Policy

Privacy Policy

Do Not Sell My Info

31 E Kings Highway
2nd Floor
Haddonfield, NJ 08033
Email: info@kenx.org
Phone: 858 649 3251

© Copyright 2020 Knowledge Exchange Network LLC. All Rights Reserved
Automating CSA Risk Management: Perspectives from BDReality Capture in Pharma: Transforming Validation with Precision and Trans...