Software Quality Assurance Part 1 of 3

The ASQ Medical Device Division DFW and Northern California Discussion Groups present part one of a three part series on Software Quality Assurance

Game Changer! Everything about FDA’s Upcoming Guidance on Computer Software Assurance Khaled Moussally and Stephen Cook

Regulatory guidance on Computer System Validation (CSV) has remained mostly unchanged and misunderstood for the past decade while. Technology has changed significantly with low coding platforms and broad adoption of 21 CFR Part 11 compliant solutions. As a result, CSV has been “labeled” as an activity that is done primarily to secure evidence for auditors, rather than value-added best practices to assure the quality of systems.
• The FDA intends to bridge this misinterpretation between regulation and technology through its upcoming draft guidance “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” (CSA).
• CSA provides further clarification and shifts the focus from documentation to critical thinking and testing, it further creates awareness to accelerate innovation. The transformation from CSV to CSA has achieved a great success and earned the support from ISPE GAMP. The FDA-Industry CSA (FICSA) Team, partnered with GAMP to co-author the CSA Appendix in the GAMP Good Practice Guide, Data Integrity by Design.

Key Benefits:
As a result of this presentation participants will:
Have pragmatic guidance on how to implement Computer Systems Assurance and Understand critical thinking and organizational change management

Khaled is a Quality & Compliance executive and a thought leader providing cutting-edge solutions to Life Sciences industry. After spending over 25+ years with corporate in IT, Manufacturing and Quality, Khaled transitioned into consulting to bring about a paradigm shift in Quality & Compliance by leveraging his experience with regulatory agencies. Khaled is a key participant of the MDIC “Case for Quality Initiatives” and a member of the “FDA – Industry CSA team” contributing to the FDA draft guidance “Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software”. Khaled is on the “ISPE GAMP America Steering Committee” and has co-presented with the FDA in numerous industry conferences on how to reduce CSV cycle times while enhancing quality by applying CSA concept.

Stephen Cook, VP, QUALITY AND COMPUTER COMPLIANCE at Compliance Group Inc
Stephen Cook has 20+ years of experience in the field of computer systems validation and is an expert on Computer Software Assurance (CSA). Stephen believes that a strong partnership between IT, Quality and the business can lead to creative solutions and that the really good work gets created outside the SOP. He’s held numerous roles in IT, manufacturing and quality. Stephen has implemented CSA at numerous clients including the development, deployment and training of end-to-end CSA SOPs and associated templates. Stephen has co-presented with clients on the success stories of his CSA implementations in several events and is an advocate of common-sense approaches over dogmatic.

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Date & Time
Wednesday September 1st, 2021 7:00pm CDT
End Date & Time
Wednesday September 1st, 2021 9:00pm CDT
virtual WebEx

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Date & Time: 09/01/2021 07:00:00 PM CDT