This panel discussion will focus on three major guidance initiatives currently shaping the future of computerized systems compliance, featuring insights from ISPE Steering Committee Americas members. Few panelists have played a key role in authoring the forthcoming Testing of GxP Systems Good Practice Guide (GPG), bringing firsthand perspective on its intent and evolution. The conversation will explore:
- FDA Computer Software Assurance (CSA) Guidance (Released): How this guidance shifts industry practice from prescriptive validation toward a risk‑based, critical‑thinking approach to software assurance.
- ISPE Testing of GxP Systems Good Practice Guide (GPG) (Draft / Under Review): A modern framework in development that defines a new approach to establishing test confidence in GxP‑regulated environments.
- EU GMP Annex 11 Revision (Anticipated): Expected updates to Annex 11 that reflect contemporary, risk‑based principles aligned with the direction set by the FDA CSA guidance.
Together, these topics represent a unified and evolving direction for global computerized systems compliance, and the panel will unpack their intent, alignment, and practical application.
Speakers:
Note: This panel is being led by vendor representatives with deep involvement in the authorship of the referenced ISPE GAMP guidance documents, along with operating company panelists.
Panel Moderator
🎤 Khaled Moussally: Executive Vice President Quality, Compliance Group
Panelists
🎤 Craig Gassman: VP, Information Technology, Vericel Corporation
🎤 Geetu Abbi: Head of Digital Quality, AlkermesCorporation
🎤 Louie Rayal: VP, Information Technology, GSK
🎤 Christopher White: Executive Director, Digital Quality, Replimune
What you will Learn
Attendees will understand the intent and key changes within the Annex 11 revision from the author team’s perspective and will be able to articulate the relationship between CSA, the Annex 11 revision, and the new Testing of GxP Systems GPG.
WHO SHOULD ATTEND:
This panel discussion is relevant to professionals involved in Computer Systems Quality Assurance, Computer System Compliance, Computer Software Assurance, Computer System Validation, IT Governance in the life sciences industry — including pharmaceutical, biotechnology, and medical device organizations.
