Data Integrity - Requirements for a GMP-compliant Data Life Cycle
14-16 May 2025, Copenhagen, Denmark
Course No. 21557
Speakers
Dr. Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Dr. Franz Schönfeld
Regierung von Oberfranken
Note: All times mentioned are CEST.
Objectives
Understand the current FDA and EU GMP regulations and guidance impacting data integrity from paper records to hybrid and electronic systems.
Understand the FDA requirements for data integrity, MHRA Data Integrity guidance and WHO guidance.
Learn what is required for a data governance system from senior management through to staff in laboratories, manufacturing and quality assurance.
Understand the data life cycle and how it is linked with the business process and where problems can occur for both paper records, hybrid systems and electronic systems.
Background
Data Integrity is a global problem and currently still a major concern with FDA and European Regulatory Agencies. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification in companies globally. The regulatory concern has been responded by the FDA issuing Compliance Program Guide that covers Pre-Approval Inspections. This document became effective in May 2012. The CPG objective 3 covers the laboratory data integrity audit. Furthermore in August 2014, the FDA issued Level 2 guidance on their web site about the sharing of login credentials for computerized systems and the use of test injections for testing into compliance.
In Europe, the UK’s MHRA issued a new version of a Guidance for Industry on Data Integrity in March 2018. This document outlines a data integrity governance system and principles for defining quality and data integrity into processes and systems. The WHO guidance is complimentary to the MHRA guidance in that it provides guidance for data governance and also expectations for records in both paper and electronic form..
As the regulators are tightening their inspection approaches it is important that managers, supervisors and users in regulated GMP laboratories understand the issues around data integrity and begin programs to ensure that their processes and systems ensure data integrity.
Target Group
This course is designed for managers and staff from health care industries as well for auditors who are responsible for the organisation and execution of audit trail (reviews) in their companies.
Testimonials
Seminar Programme as PDF