CSA Final Guidance Has Arrived!
Join Compliance Group and FICSA experts for an exclusive 7-part webinar series, as we break down the CSA journey and its practical application in your organization. Each episode dives into key aspects of CSA, from industry reactions to risk-based assurance strategies and future impact.
Special Series Schedule:
Episode 1
Topic: From Draft to Reality: Tracing the Path to the CSA Guidance Journey
Description: Explore the historical context and challenges in software validation that led to the development of the FDA’s draft guidance on Computer Software Assurance.
Episode 2
Topic: Industry Reactions to CSA Draft Guidance: Key Takeaways and Adjustments
Description: Industry’s response to the draft guidance, highlighting significant comments, concerns, and the FDA’s efforts to address them.
Episode 3
Topic: Understanding the Scope of CSA Guidance: What It Does and Doesn’t Cover
Description: Explore the applicability of CSA to production and quality systems, distinguishing it from design validation of medical devices and general business software.
Episode 4
Topic: Building a Risk Framework for CSA: Evaluating Software’s Intended Use
Description: Learn how to assess the intended use of software, identify risks, and classify software features as high or low process risk to guide assurance activities.
Episode 5
Topic: Crafting Risk-Based Assurance Strategies: Tools and Testing Techniques
Description: Delve into assurance methods such as scripted and unscripted testing, error-guessing, and exploratory testing, and their application based on risk levels.
Episode 6
Topic: Documenting CSA Activities: Establishing the Appropriate Records
Description: Understand documentation requirements, including objective evidence, assurance records, and leveraging digital tools for compliance.
Episode 7
Topic: CSA’s Future Impact: Transforming Production and Quality Systems
Description: Look ahead to the long-term implications of the finalized CSA guidance on innovation, compliance, and operational efficiency in regulated industries.
Speakers:
🎤 Khaled Moussally: EVP Corporate Development and Operations, Compliance Group Inc
🎤 Ken Shitamoto MS: Executive Director-IT, Quality & Compliance, Gilead Sciences
🎤 Joanne Goldberg: Senior Principal IT Business Analyst, Medtronic
🎤 Ray Murphy: Software Quality Engineering Fellow, Boston Scientific
🎤 Margie Hindley: Director-Computer Software Assurance, Taiho Oncology, Inc.
🎤 Anake Kiatdilokrath: Senior Principal Quality System Specialist, Medtronic
🎤 Damien Philips: Sr. Director Quality, Global Software and Digital at Boston Scientific
🎤 Louie Rayal: VP Governance, Risk & Compliance, GSK
🎤 Francisco Vicenty Director, Continuous Improvement, ACT Quality & Regulatory, Getinge
“Don’t miss this opportunity to gain expert insights and actionable strategies! Stay tuned for updates.”
Meeting date: Coming Soon