Webinar "How to Validate AI/ML in Life Sciences, the Future of Computer System Validation"
Artificial Intelligence and Machine Learning are transforming the Life Sciences industry. But how can we validate these technologies under GxP requirements?
What do regulators expect, and how do frameworks such as GAMP5® 2nd Edition and the EMA Annex 22 draft reshape validation strategies?
Watch this exclusive webinar, where our experts cover:
Practical steps to validate AI/ML in GxP-relevant applications
Key insights and industry comments on the EMA Annex 22 draft for AI in GMP
How risk-based approaches accelerate compliance without compromising quality
How AI/ML integration is changing the future of validation
Get in touch: [email protected]
GAMP5® is a guide that has its intellectual rights reserved by ISPE®. Available for purchase at https://ispe.org/.
Chapters:
0:00:00 Introduction
0:08:36 Key Reasons to Validate AI/ML in GxP Applications
0:11:39 Traditional System Validation vs. AI/ML Validation
0:13:42 Challenges in AI/ML Validation
0:16:27 Key Regulations and Guidelines
0:20:28 Blog Guide - How to Validate AI
0:22:09 Extra Materials
0:23:38 AI/ML Custom Lecture
0:25:30 CSV Course
0:27:20 Core Principles for AI/ML Validation
0:29:32 Interpretability vs. Complexity
0:31:32 Bias Mitigation and Result Reliability
0:32:35 Data Management and Quality for AI/ML Models
0:34:25 Data Governance
0:35:00 Lifecycle and Monitoring
0:38:03 Digital Validation
0:40:43 Essential AI/ML Free Guide
0:43:23 ISPE® GAMP® AI Guide
0:43:44 EMA Annex 22
0:45:36 Scope, Personnel and Documentation
0:46:52 Validation, Explainability and Confidence Criteria
0:49:27 Stakeholder Feedback and Industry Concerns
0:52:06 Bridging Compliance and Innovation
0:54:07 Regulation vs. A European Crosscroads
0:56:11 Question 1
01:05:46 Question 2
01:08:33 Question 3
01:11:17 Question 4
01:14:20 Question 5
01:17:11 Question 6
01:18:50 Question 7