AI is changing how the FDA works, and how sponsors need to prepare. As AI reshapes the regulatory landscape, sponsors face new challenges in maintaining inspection readiness. The FDA’s forthcoming implementation of Elsa, its new AI-driven inspection tool, signals a transformative shift in how inspections and quality oversight will be conducted. At the same time, sponsors are under increasing pressure to do more with less, navigating tighter budgets, leaner quality teams and complex compliance expectations.
In this webinar, the featured speakers will unpack what the rise of AI means for inspection preparedness. They’ll explore how Elsa may change the inspection process, what FDA reviewers may look for in AI-assisted audits and how sponsors can proactively assess, strengthen and document their quality systems to stay inspection-ready in this new environment.
Register for this webinar to learn how inspection readiness can evolve to meet the demands of AI-enabled regulatory oversight.
Speakers
Abe Seckler, Managing Director, GxP Services, Advarra
With over 20 years of experience in the pharmaceutical and life sciences industries, Abe is an accomplished senior leader specializing in global quality strategy, business operations and R&D at both start-ups and the largest pharmaceutical companies. This has included developing novel products, establishing global quality governance and ensuring compliance with external and internal requirements.
Message Presenter
Dennis Rodman, Senior Director, Quality Management Systems & Digital Compliance, Intellia Therapeutics
Dennis serves as Senior Director of Quality Management Systems and Digital Compliance at Intellia Therapeutics, bringing deep expertise in quality systems and regulatory compliance to the biotechnology sector. With a strong foundation in operations and efficiency, he champions integrating artificial intelligence and automation to transform compliance processes and drive operational excellence.
Message PresenterWho Should Attend?
This webinar will appeal to senior professionals from sponsors (pharma, biotech and medical devices) and CRO organizations involved in:
- Clinical Operations
- Compliance
- Quality Control
- Regulatory Affairs
- Innovation
- IT
What You Will Learn
Attendees will gain insight into:
- Common risks sponsors face in maintaining quality oversight amid budget and staffing constraints
- Strategies to strengthen inspection readiness programs to align with emerging AI-driven regulatory review processes
- How forward-thinking teams are turning this industry shift into a competitive advantage
Xtalks Partner
Advarra
Advarra is number one in trusted research review services, number one in site operations technology, and the pioneer in study collaboration solutions. Our unique portfolio of technology and services reduces friction by decreasing technology burden, improving study visibility, and enabling smarter decisions that advance clinical research.
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account