Description:
As industries in the Life Sciences undergo digital transformation, moving away from traditional Computer System Validation (CSV) to a risk-based, value-driven Computer Software Assurance (CSA) approach, has become essential for aligning with evolving regulatory landscape. This shift enables teams to validate modern technologies, like Artificial Intelligence (AI) and Machine Learning (ML), with agility and precision while ensuring patient safety, product quality, and data integrity.
In this webinar, experts from Compliance Group Inc., the U.S. FDA, and Flex will explore how organizations in the life sciences industry can meet evolving regulatory expectations while embracing Digital Validation Tools (DVTs) to advance data integrity, operational efficiency, and compliance. With the increasing complexity of modern systems and the shift towards digital transformation, the panel will also discuss how Computer Software Assurance (CSA) provides a scalable, risk-based validation framework relevant for AI/ML systems aligned with Agile methodologies, modern SDLCs, and continuous delivery, while ensuring that systems remain in a validated state throughout their operational lifecycle.
Key Takeaways:
- Gain clarity on the regulatory expectations driving the shift from traditional CSV to CSA.
- Understand how Digital Validation offers practical, risk-based best practices for defining, implementing, and managing DVTs within a regulated environment.
- Learn how to risk-assess AI systems for validation, addressing model training, drift, bias, and explainability using risk-based controls
- Best practices for documenting AI validation aligned with regulatory expectations.
- Real-world case studies from pharma, MedTech examples using AI/ML.
Who Should Attend?
- QA & Compliance Professionals
- Validation & CSV Specialists, Validation Managers
- Quality Assurance Leads
- Regulatory Affairs Leaders
- IT & Digital Transformation Teams
- R&D & Engineering Managers
- AI/ML & Automation Leads
- Pharma, Biotech & MedTech Executives
Speakers:
🎤 David DeLuca: Director, Strategic Consulting, Compliance Group Inc
🎤 Sarada Ramamoorthy: Head, Strategic Consulting, Compliance Group Inc
🎤 Garth Conrad: Vice President, Quality, Flex Health Solutions
🎤 Seneca Toms: Drug National Expert, U.S. FDA
Meeting date: June 18, 2025, 11:00 AM to 11:45 AM ET