Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 29th Jun'25 to 09th Jul'25
Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data
During the webinar, we will discuss the following:
- Learn about how AI and ML are 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.
- 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.
- Current and potential uses of AI, and ML in health care and the challenges posed.
- How and under what circumstances products relying on AI are regulated by FDA.
- Learn about the potential impact and risk threatening data, processes, products, and ultimately patients based on these tools being misused, and often misunderstood.
- Learn how to ensure benefits of products outweigh risks.
- 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.
- 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 innovative technology in operational processes in today’s FDA-regulated companies.
- Industry best practices and recommendations for improving compliance of products that leverage innovative technology in operational processes.
- Learn about industry best practices for implementing, validating, meeting FDA Part 11 and data integrity requirements, as applications that incorporate AI and ML capability improve operational efficiency and effectiveness in the process.
Overview of the webinar
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, ML and others are 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 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 newer technologies in software development, testing, and support.
It is time to embark on the latest technology 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.
Who should attend?
Professionals in the following industries may benefit from the content:
- Pharmaceutical
- Medical Diagnostics
- Medical Devices
- Vendors of Software Used with Medical Devices
- Biotechnology
- Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
- Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
Recommended Attendee Profiles:
- Information Technology Managers, Developers and Analysts
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Compliance Managers
- Lab Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
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. There is ample opportunity as we embark on implementing newer, innovative technologies, such as Artificial Intelligence (AI) and Machine Learning (ML) in systems regulated by FDA.
One of the largest current threats to medical 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 these innovative technologies 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 is to try to stay ahead of the curve, but this is increasingly more challenging and difficult. 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, regulatory submissions, 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. You should also attend to learn what role these advanced technologies may play in the future of product delivery, making your operations more efficient while meeting FDA compliance requirements.
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 40+ years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.