Learn how to meet EU Annex 22 requirements while harnessing AI, ML, and LLMs with the critical human oversight needed for quality, compliance, and ROI.
Includes live access & recording
Providing safe and effective FDA-regulated products is in the best interests of all those involved in their development, manufacturing, testing, and distribution. With newer technologies such as AI in the mix, it means opportunity for greater efficiency and efficacy, but also poses more challenges for companies that develop, test, and support software applications in the life science industries.
AI can hallucinate, and show bias and performance drift. The human expert must be able to critically assess the output and make the judgment calls for better decisions, quality, and compliance, and to optimize ROI.
In this webinar, you will learn just how AI, ML and LLMs, such as ChatGPT can increase efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions and new innovative products that will drive industry over the coming years.
In particular, you'll learn about the need for human review by the expert who applies critical thinking to ensure better outcomes, decisions, quality, patient safety, compliance, and ROI.
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.
Whether involved in software development, testing, implementation, validation, maintenance or use of AI-enabled solutions, you will find a wealth of knowledge to enhance your ability to use these technologies with maximum effectiveness.
We will review industry best practices to know where to gather key information to help you move forward with these technologies quickly and in compliance with FDA. Those using these systems must understand their role as the human guardrail of AI, critically assessing the outcomes and making intelligent judgment calls to ensure better decisions, quality, compliance, and ROI.
By the end of this session, participants will be equipped to govern AI systems effectively within GMP-regulated environments using critical human oversight.
Understand EU Annex 22 requirements for AI governance, including human review, model monitoring, and change control.
Identify how AI, ML, and LLMs can increase efficiency and effectiveness of SDLC activities in life science organizations.
Apply critical thinking skills to assess AI output and make sound judgment calls for quality and compliance decisions.
Distinguish between Computer System Validation (CSV) and Computer Software Assurance (CSA) and transition effectively between them.
Meet 21 CFR Part 11 requirements for systems using AI technology, including data integrity through human review.
Recognize and mitigate AI risks including hallucination, bias, and performance drift to protect product quality.
Leverage GAMP®5, 2nd Edition principles aligned with CSA to validate and maintain AI-enabled solutions.
Prepare for inspection readiness when deploying AI solutions in FDA-regulated environments.
Four focused areas that will transform how your organization approaches AI compliance in GMP-regulated settings.
Understand all key aspects of EU Annex 22 as it applies to Human Review, Model Monitoring, and Change Control for AI-enabled systems.
Learn how experts with deep and broad knowledge can critically assess AI output and serve as the essential guardrail for better outcomes and decisions.
Understand hallucination, bias, and performance drift — and implement safeguards to ensure quality data input and reliable AI output.
Navigate the shift from traditional Computer System Validation to Computer Software Assurance using the latest GAMP®5, 2nd Edition framework.
A comprehensive deep-dive across critical areas of AI governance and GMP compliance in regulated life science environments.
Professionals responsible for planning, executing, or managing computer system validation activities in FDA-regulated industries.
IT Analysts & Developers
IT Testers
QC/QA Managers & Analysts
Analytical Chemists
Compliance & Audit Managers
Laboratory & Manufacturing Managers
Automation Analysts & Managers
Supply Chain Specialists
Regulatory Affairs Specialists
Clinical Data Analysts & Managers
CSV Specialists & GMP Training Staff
Consultants & Internal Auditors
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, we've seen 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), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT are 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 more prevalent. In addition, the European Union (EU) has issued Annex 22 for AI governance.
LLMs, including ChatGPT trained on vast datasets embody the ultimate black box in the realm of FDA regulation. They are nonlinear and high-dimensional, making it difficult to trace specific inputs to outputs. A risk is they may return wrong answers when trained on unreliable datasets. AI can hallucinate, and show bias and performance drift. AI solutions need human guardrails — experts who can evaluate output and, based on broad and deep expertise, make the right judgment calls for better outcomes and quality decisions.
We'll cover all key aspects of EU Annex 22 as it applies to Human Review, Model Monitoring, and Change Control. We'll provide an overview of validation, including CSV and Computer Software Assurance (CSA), and the latest GAMP®5, 2nd Edition that aligns with CSA.
Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects.
Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA's Guidance for Electronic Records and Electronic Signatures. During her career she has provided training, including CSV, 21 CFR Part 11, Data Integrity, and many other related compliance topics of interest to the life science industries.
Don't miss this essential training on EU Annex 22, AI governance, and the critical human oversight required for GMP compliance.