Using a risk-based approach to comply with FDA's 21 CFR Part 11
Join us for an insightful and comprehensive webinar on how to validate products to FDA’s 21 CFR Part 11 standard using a risk-based approach (i.e.Computer System Assurance).
This event is designed to provide developers and quality/regulatory professionals with a clear understanding of the latest developments in validation and regulatory guidance from the FDA/EMA and how to implement a risk-based approach to compliance.
What you'll learn
- Part 11 Compliance and CSA: Gain insights into the significance of 21 CFR Part 11 compliance in the context of electronic records and electronic signatures. Understand the principles of Computer System Assurance and its application in maintaining data integrity and security.
- Review of New FDA and EMA Guidances: Stay up-to-date with the latest regulatory guidance from the FDA and EMA including the integration of Real-World Evidence and clinical trial IT validation. Learn how these guidelines shape the landscape of clinical research and impact data validation strategies.
- Implications for Existing SaaS Products: Discover how cloud-based Software-as-a-Service (SaaS) products are affected by the evolving regulatory landscape. Understand the potential challenges and opportunities posed by the new guidelines and how to navigate them effectively.
- Transitioning to Part 11 Compliance: Delve into practical approaches for implementing Part 11 compliance within your product, particularly in the context of cloud-based solutions. Gain valuable insights into the steps, strategies, and tools needed to smoothly transition your product to align with the regulatory requirements.
Who should attend
- Research and development teams
- Regulatory affairs and compliance personnel
- Software development teams
- Professionals working in clinical trials, real-world date/evidence