5th Computer Software Assurance 2025

This virtual workshop-style program focuses on elevating pharmaceutical validation through the application of Computer Software Assurance (CSA), AI, and Agile methodologies. Scheduled for August 21–22, 2025, the summit addresses the increasing complexity of software in pharmaceutical manufacturing and proposes risk-based, efficient approaches to validation. It places special emphasis on regulatory alignment, data integrity, and practical case studies that equip attendees with tools to implement CSA effectively.

Designed with implementational rigor in mind, the training includes pre-conference virtual sessions, interactive group activities, case-study workshops, personalized 1-on-1 doubt-clearing with CSA/CSV experts, and lightning sessions on emerging technologies and future trends in pharma validation. With extended post-event support, participants receive up to six months of access to follow-up help on questions and applications.

Notable Speakers and Faculty

• Ken Shitamoto — Executive Director, IT Quality & Compliance, Gilead Sciences (keynote and workshop leader)

• Sarada Ramamoorthy — Head of Strategic Consulting, Compliance Group Inc. (key workshop facilitator)

• Deepa Pangaonkar — Quality & CSA Training Expert, Wockhardt/Biological E.

• Pranav Gadre — Head, IT/QA Teams, Reliance Life Sciences

• Khaled Moussally — Digital Validation Systems Specialist, Compliance Group