Description
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent. During the last decade, the FDA became alarmed by the lack of compliance with data integrity and Part 11 requirements.
It has become increasingly obvious that most of the performers in the industry are under management pressure to do more work with fewer resources and in less time. This continues to lead performers to seek faster and easier work with fewer resources and in less time. This continues to lead performers to seek faster and easier ways to get the work done and opens the door to more conversation around the use of AI in software development, testing, and support.
In this webinar, attendees will learn how AI can increase the efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions that will drive the industry over the coming years.
Webinar Highlights:
- The webinar will discuss Artificial Intelligence (AI) and Machine Learning (ML).
- Understand the application of AI and ML in computer systems used in FDA-regulated activities.
- Focus on the challenges of using AI and ML in computer systems used in FDA-regulated activities.
- Learn about traditional Computer System Validation (CSV) and the more current draft guidance from the FDA on Computer Software Assurance (CSA) and how the latter aligns with AI and ML.
- Attendees will gain knowledge about GAMP5, 2nd Edition, and how it aligns with both CSA and AI and ML solutions.
Why Should You Attend:
- Attendees will learn the best approach to maintaining computer systems that include AI and ML in a validated state.
- Understanding 21 CFR Part 11 requirements for FDA compliance and how these apply to AI- and ML-enabled systems.
- Focus on data integrity requirements for FDA compliance and how these apply to AI- and ML-enabled systems.
- Learn about how to comply with the FDA using Commercial Off-the-Shelf (COTS) software applications, cloud-based systems, and Software-as-a-Service (SaaS) solutions.
- Attendees will get to know about FDA compliance trends and best practices.
- The webinar will benefit the attendees in the Q&A session.
Who Should Attend:
- Pharmaceutical
- Medical Device
- Biologicals
- IT Developers & IT Analysts
- QC/QA Managers and Analysts
- Manufacturing Personnel
- Clinical Data Managers & Scientists
- Compliance Managers & Auditors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industries
- Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to the FDA
