FDA's Current Thinking on 21 CFR Part 11 &
Its Implication on CSA Draft Guidance

Presented by:

Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic
Khaled Moussally, EVP Clients & Regulatory Relations, Compliance Group
Francisco Vincenty, Program Manager, Case for Quality, U.S. FDA
Daniel Walter, Policy Analyst, U.S. FDA

Since the release of the FDA draft on Computer Software Assurance (CSA), September 13th, 2022, many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11. The FDA, FICSA and CG will have an open discussion around the implications and opportunities that may impact the 21 CFR Part 11 while applying CSA methodology.

This webinar will cover the following topics:

The Myth Vs Fact that CSA may compromise the quality of computerized systems
Being compliant with 21 CFR Part 11 in 2023 versus 1997 – Regulation did not change
Shift away from matching the phraseology of the regulations to meeting the intent of the
regulations
Leveraging the best technology to ensure authenticity, integrity and the confidentiality of
electronic records

SPEAKERS

Joanne Goldberg

Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic

Joanne Goldberg is an experienced software quality professional with over twenty years of experience in systems development, maintenance, and compliance. She is passionate about developing innovative and rigorous solutions to quality problems. Joanne has a strong track record of mentoring teams to implement effective and sustainable compliance processes, and she is recognized as a champion for the advancement of women in science & technology and equity for all.

Khaled Moussally

EVP Clients & Regulatory Relations, Compliance Group

A Versatile global Quality / IT executive with over 25+ years of quality and compliance, experience in highly regulated life science industries (Medical Device, Bio-tech, Pharmaceutical and Tobacco). Deep understanding in the Manufacturing processes, Equipment validation and Lab Information Systems. Extensive background in Quality Management Systems, regulatory inspections and internal audits. Member of an FDA/Industry CSV Consortium, focusing on developing risk-based recommendation to reduce time and cost in validating software.

Francisco (Cisco) Vicenty

Case for Quality Program Manager, U.S. FDA (Invited)

Mr. Vicenty is an Experienced Quality Program Manager with a demonstrated history of working in the government administration industry. Strong community and social services professional skilled in Mechanical Engineering, Engineering Management, Semiconductors, Process Engineering, Engineering, Quality and Reliability.

Daniel Walter

Policy Analyst, FDA

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FDA's Current Thinking on 21 CFR Part 11 & Its Implication on CSA Draft Guidance

SPEAKERS

Daniel Walter

FDA's Current Thinking on 21 CFR Part 11 &
Its Implication on CSA Draft Guidance