Data Integrity Master Class with full-day pre-course session Raw Data
26-29 August 2025, Copenhagen, Denmark
Course No. 21591
Speakers
Dr. Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Dr. Wolfgang Schumacher
formerly F. Hoffmann-La Roche
Dr Franz Schönfeld
Regierung von Oberfranken
Note: All times mentioned are CEST.
Objectives
Pre-course session "Raw Data - Understanding, Defining and Managing"
The aim of this one day course is to understand what can be defined as raw data and to explore the meaning of the term for manufacturing, laboratory and quality records. Is there harmonisation of US and EU GMP regulations? For example:
What is a “quality decision” and what is the impact of having to define raw data for the process or system?
Can raw data be equivalent to complete information and complete data?
Should we treat manufacturing “information” and laboratory “data” as the same?
Data Integrity Master Class
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
Pre-course session "Raw Data - Understanding, Defining and Managing"
FDA GMP in 21 CFR 211 requires “complete information” for manufacturing records and “complete data” for laboratory records. In contrast, Chapter 4 of EU GMP on documentation contains in the Principle three sentences that are in apparent contradiction to the United States regulations:
Records include the raw data which is used to generate other records
For electronic records regulated users should define which data are to be used as raw data
At least, all data on which quality decisions are based should be defined as raw data
In the days of harmonisation of regulations how can we reconcile these differences? This situation is compounded by the failure of EU GMP to define the term “raw data” in the regulations to help industry plan their approach to meeting these regulatory requirements.
Data Integrity Master Class
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
Raw Data Tuesday, 26 August 2025, 09.00 – 17.15 h (Registration and coffee 08.30 h - 09.00 h)
Data Integrity Masterclass 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