Webinar "EU GMP Annex 11 Draft – What Is Changing and How It Impacts Computerized Systems" скачать в хорошем качестве

Webinar "EU GMP Annex 11 Draft – What Is Changing and How It Impacts Computerized Systems"

This webinar will provide an overview of the EU GMP Annex 11 draft revision, focusing on its impact on computerized systems, validation strategies, data integrity, and modern digital environments within regulated industries. The session is designed to help organizations understand what is new and how to prepare in a pragmatic and risk-based way. Get in touch: contact@fivevalidation.com Chapters: 00:00 Introduction 04:40 Regulatory Context 06:30 CSV Regulatory Landscape: BR vs USA vs EU 09:17 Why Annex 11 is being revised 10:36 Annex 11 Draft: Key Changes 11:55 5 Major Thematic Changes 13:20 Lifecycle and Risk Management 14:40 Lifecycle Governance 16:15 Data Integrity Focus 17:25 Identity and Access Management (IAM) 18:40 Audit Trails & Controls 19:47 Inspection Readiness 20:57 Supplier & Cloud Service Oversight 22:08 Impact on Validation (CSV & CSA) 23:20 Modern Digital Technologies 25:27 Roles, Responsibilities & Governance 26:40 Practical Recommendations 28:20 Why traditional validation struggles 30:00 Why manual approaches increase inspection risk 31:40 From document-centric CSV to digital lifecycle control 33:05 GO!FIVE Operational Mapping 35:10 EMA Draft 36:17 How FIVE Validation supports this 37:43 Closing & Next Steps 39:30 Questions & Answers