Note: All times mentioned are CEST.If you book this course together with the course "Raw Data - Understanding, Defining and Managing," we will offer you a discount of € 600,-
Objectives
Your will get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements
You will get a deeper understanding what FDA and European inspectors expects from pharmaceutical companies in regard to Data Integrity
You will learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System
You will learn how to prepare your company for a successful inspection in regard to Data Integrity
You will understand how to establish an effective Data Governance System
You will learn how to investigate Data Integrity issues in your company
Background
Even Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue be the focus of many GMP inspections.
As a consequence, international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe the regulatory expectations of Data Integrity.
Although all guidelines are not intended to impose additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry how to implement these requirements into the daily business.
Target Group
The courses are directed at
Managers and staff from Manufacturing, QC/QA and Analytical Development Laboratories of pharmaceutical companies
Contract Research Organisation and Contract Manufacturing Organisation manufacturing, laboratory and QA personnel
Auditors (internal and external) responsible for performing self-inspections or external audits and needing to understand and assess data integrity
Especially the Data Integrity Master Class course is directed to participants who have first experiences in Data Integrity, e.g. the ECA course “Data Integrity – Requirements for a GMP compliant Data Life Cycle".
Date / Venue / Presentations / Certificate
Wednesday, 27 August 2025, 09.00 h – 17.30 h (Registration and coffee 08.30 h - 09.00 h) Thursday, 28 August 2025, 08.30 h – 17.30 h Friday, 29 August 2025, 08.30 – 15.30 h
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
For Attendees Only
Attendees will get a free electronic copy of ECA “GMP Data Governance and Data Integrity Guide” - Version 3
Testimonials
Seminar Programme as PDF