Data Integrity - Requirements for a GMP-compliant Data Life Cycle - Live Online Training
20-22 November 2024
Seminar-Nr. 21486
Referent:innen
Dr. Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Dr. Franz Schönfeld
Regierung von Oberfranken
Note: All times mentioned are CET.
Zielsetzung
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 July 2016 and WHO guidance from September 2015.
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.
Hintergrund
Data Integrity is a global problem and currently 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.
Zielgruppe
This Live Online Training 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.
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical- information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Teilnehmerstimmen - das sagen andere über unsere Seminare:
„"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen. Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.” Christian Wagener, WAGENER & CO. GmbH GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023
„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“ Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024