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

Описание: 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: [email protected]

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