GCP & Data Integrity for Analytical Laboratories – ICH E6 R3 in Practice
20 November 2025
750 €
TRAINING TIMES
09:00 - 12:00 Vienna
08:00 - 11:00 London
03:00 - 06:00 New York
00:00 - 03:00 Los Angeles
WHY SHOULD YOU ATTEND?
Grasp
the updates and intent behind ICH E6 R3 and its application to analytical labs.
Recognize
how data integrity and documentation responsibilities are shared and auditable.
Understand
what qualifies as personal data under GDPR and how to handle it securely.
Be prepared
to act in alignment with GCP expectations during audits and sponsor interactions.
OUR ONLINE TRAINING EXERIENCE INCLUDE
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
LEARNING OBJECTIVES
Comparison R2 vs R3 - Focus shift: risk-based quality, traceability, shared oversight
Annex 1: documentation, delegation
Data integrity: ALCOA++
GDPR: personal data in lab workflows
GxP system validation (LIMS, spreadsheets)
Change control and audit preparation
WHO IS THIS TRAINING FOR?
Project Managers
Regulatory Affairs Specialists
Clinical Data Managers
Data Integrity Managers
KEY TOPICS
What does GCP mean in your daily work?
Analytical CRO Responsibilities under GCP R3
Interactive Q&A and Case Reflections
ICH E6 R3 – What’s New and Why It Matters
GDPR, GxP Systems & Inspection Readiness
Practical do’s & don’ts for laboratories
TRAINER
PAST PARTICIPANTS
GCP & Data Integrity for Analytical Laboratories – ICH E6 R3 in Practice
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
