Faculty: Carolyn Troiano ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3645


  • Date: 4/26/2024 11:00 AM - 4/26/2024 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event

 

Description

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.

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 artificial intelligence (AI) and machine learning (ML) 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 AI/ML in software development, testing, and support.

It is time to embark on the AI/ML 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.

Why You Should Attend:

Delivering safe and effective FDA-regulated products is paramount, and cyberattacks pose a significant threat to their integrity. These attacks can disrupt code and device functionality, endangering patients and companies alike. Identifying and thwarting these threats before they strike is critical, especially with the integration of AI, which brings its own set of challenges to the life science software industry.

Join our webinar to discover how AI can revolutionize software development life cycle (SDLC) activities, enhancing efficiency and effectiveness in delivering solutions that will shape the industry's future.

Explore the evolving landscape of cybersecurity threats against medical devices and industry responses. Learn proven strategies for preventing and mitigating these risks, along with industry best practices to safeguard your organization.

This webinar caters to FDA-regulated industries, including pharmaceuticals, medical devices, biologics, animal health, and tobacco. It's relevant for roles in research, development, manufacturing, quality control, distribution, clinical testing, adverse event management, post-marketing surveillance, and anyone overseeing FDA medical device or software-regulated systems.

If you're involved in planning, executing, managing, or supporting FDA-regulated systems, this webinar is your essential guide to staying ahead of cybersecurity challenges.

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.
  • 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/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.
  • 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 AI in operational processes in today’s FDA-regulated companies.
  • Industry best practices and recommendations for improving compliance of products that leverage AI in operational processes.
  • 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.

Who Should Attend:

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Specialists and Managers
  • Supply Chain Specialists and Managers
  • Regulatory Affairs Specialists
  • Regulatory Submissions Specialists
  • Clinical Data Analysts
  • Clinical Data Managers
  • Clinical Trial Sponsors
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers

Course Director: CAROLYN TROIANO

 

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

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.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.