AI, ML, and FDA Compliance for Computer Systems, and Data

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.

FDA became alarmed by the lack of compliance to meet data integrity and Part 11 requirements during the last decade. Out-of-compliance citations during this period, including Form 483s and Warning Letters have skyrocketed for these key areas of compliance. But why?

Based on discussions with clients and stakeholders at conferences and meetings, it has become more and more 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 ways to get the work done and opens the door to more conversation around the use of AI in software development, testing, and support.

It is time to embark on the AI revolution and continue to deliver quality products with compliance to meet the needs of the consumers by putting newer, more innovative, safer, and more effective products in their hands, all of which are key focus areas for FDA.

Areas Covered:-

• Learn about Artificial Intelligence (AI) and Machine Learning (ML)
• Understand the application of AI and ML in computer systems used in FDA-regulated activities
• Understand 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• Learn about traditional Computer System Validation (CSV) and the more current draft guidance from the FDA on Computer Software Assurance (CSA) and how the latter aligns with AI and ML
• Learn about GAMP®5, 2nd Edition, and how it aligns with both CSA and AI and ML solutions
• Learn the best approach to validating computer systems that include AI and ML
• Learn the best approach to maintaining computer systems that include AI and ML in a validated state
• Learn about 21 CFR Part 11 requirements for FDA compliance and how these apply to AI- and ML-enabled systems
• Learn about 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
• Learn about FDA compliance trends
• Learn about industry best practices
• Q&A

Background:-

The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA.

In addition to some trends toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations that have more recently begun to be used more heavily in life science companies, Artificial Intelligence (AI) is beginning to find a presence at these companies.

While life science companies tend to lag behind other markets in using these technologies, they are catching up and we are seeing much more activity related to AI use in software applications used to develop, produce, test, and manage life science products with quality and compliance.

Why You Should Attend:-

Providing safe and effective medical devices, drugs, and other FDA-regulated products is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. One of the largest current threats to these devices working safely and effectively is cyberattacks that can wreak havoc on code and device functionality. Preventing these attacks by identifying sources of threats and rooting them out before they can take effect is of the utmost concern. And with newer technologies such as AI in the mix, it means more challenges for companies that develop, test, and support software applications in the life science industries.

In this webinar, you will learn just 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 industry over the coming years.

Who Should Attend?

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Manufacturing Personnel
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by the FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students are attending schools and studying computer system validation, regulatory affairs/matters (related to the FDA), or any other discipline that involves adherence to FDA regulatory requirements.

Event Venue

Online