AI, ML & FDA Compliance for Computer Systems & Data

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.

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 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 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.

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 Webinar:

This webinar will cover the following key areas:

• 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:

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Examples of who will benefit from this webinar include:

• 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
• Risk Management Professionals
• 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
• This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Keywords Related to this Training:

Artificial Intelligence (AI), Machine Learning (ML), Locked Algorithm, Adaptive Algorithm, Real World Evidence (RWE) and Real World Data (RWD), International Medical Device Regulators Forum (IMDRF), IMDRF Risk Framework, Software-as-a-Medical-Device (SaMD), Software-in-a-Medical Device, Privacy Data, Computer System Validation (CSV), Computer Software Assurance (CSA), GAMP®5, 2nd Edition (Good Automated Manufacturing Practice) and Software Categorization, Cloud Services, Software-as-a-Service (SaaS), Single and Multi-Tenant Cloud Service Providers, Agile, Waterfall, 510(k) for Software Change to an Existing or New Device, Risk Assessment and Mitigation, Treat or Diagnose (Category II-IV), Drive Clinical Management (Category I-III), Inform Clinical Management (Category 1-II), Changes to Performance, Inputs & Intended Use, Total Product Lifecycle (TPLC) Regulatory Approach, Good Machine Learning Practice (GMLP), Quality Management System (QMS), Pre-Specifications (SPS), Algorithm Change Protocol (ACP), Case for Quality Program, FDA Pre-Certification Program, Focused Review, Substantial Equivalence (SE), De Novo Pathway, Clinical Decision Support (CDS) Software, 21st Century Cures Act, SaMD and Software-in-a-Medical-Device Products in Networked Environments, Cybersecurity, SOC 2 Compliance (Systems and Organizational Controls), IT Change Control, Validation Planning, Validation Execution and Testing, Validation Reporting, GAMP®5 “V” Model, Medical Device Recalls, Critical Thinking, Automated Testing, 21 CFR Part 11 (Electronic Records/Signatures), Data Integrity

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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