“Computer Software Assurance for Manufacturing, Operations, and Quality System Software

In this webinar hear directly from the “FDA/industry CSA Team member”, featuring industry experts, who will conduct a panel discussion, about the upcoming draft Computer Software Assurance (CSA) draft guidance from FDA’s CDRH division. The guidance covers the principles of risk-based CSA, provide FDA’s perspective, and share numerous real-life success stories and their resulting value.
ISPE GAMP® global leadership strongly supports this risk- and quality-based approach to the assurance of computerized systems and believes that current ISPE GAMP® guidance is already fully aligned and consistent with such an approach, including new guidance coming this year from the CDRH.
About the Panel

Khaled Moussally – EVP, Clients & Regulatory Relationships – Compliance Group Inc.- Khaled Moussally has 25+ years of experience in the Life Sciences industry and is a well-known and well-respected thought leader on Quality & Compliance. Khaled is a key member of the FDA Case for Quality / "FDA CSV Industry Team", a contributing author to to the upcoming FDA guidance on Computer Software Assurance (CSA) and a contributing ISPE GAMP member to the Appendix of the Good Documentation Guidance on Data Integrity.

Stephen Cook – VP, Quality and Computer Software Assurance – Compliance Group Inc.
Stephen Cook has 20+ years of experience in the field of computer systems validation and is an expert on FDA’s upcoming guidance on Computer Software Assurance (CSA)

Harsha Chulki: Head of Global IT Quality, Compliance & CSV - ICU Medical Inc.-Harsha is responsible for ensuring high quality and compliant solutions are developed and deployed by ICU Medical's Global IT organization. A key player in the transition of regulated systems.

Sachin Bhandari Chairman, ISPE, Steering Committee Member - GAMP India CoP. Experienced professional in Pharmaceutical and healthcare compliance domain with wide experience in GXP, 21 CFR part 11, GAMP 5 and other compliance requirements and adherence.