Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA
During the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.
You’ll also learn about how FDA, Congress, technology developers, and health care industry must work together to forge this new path and lead to a deeper and broader application of AI in operational processes in today’s FDA-regulated companies. We’ll discuss industry best practices and recommendations for improving compliance of products that leverage AI in operational processes.
Why should you 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 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.
cyberattacks threaten medical devices and how industry is currently responding to them. We will discuss the many ways of preventing and mitigating the cybersecurity risk, and about the industry best practices that can help your company do the same.
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
You should attend this webinar if you are responsible for planning, executing or managing the development or implementation of any system governed by FDA medical device or software regulations, or if you are maintaining or supporting such a system.
Areas Covered in the Session:
- Learn about how AI increasing in use in the life sciences industries, and how companies are leading the way to delivering more effective, safer, and more beneficial products as a result
- Learn about the challenges and vulnerabilities facing industry today
- Learn what FDA is doing to confront the increase in cyberthreats posed with the advent of newer technologies and what further work may be done
- Learn about the potential impact and risk threatening data, processes, products, and ultimately patients based on these
- Learn about industry best practices for implementing, validating, meeting FDA Part 11 and data integrity requirements, as AI applications improve operational efficiency and effectiveness in the process
- Q&A
Who Will Benefit:
- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- IT Security Staff
- QC/QA Managers and Analysts
- Production Managers and Supervisors
- Supply Chain Managers and Supervisors
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Computer System Validation Specialists
- GMP, GLP, GCP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industries
- Interns working at the companies listed above
- College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.