Date: June 17, 2026, Online
In recent years, data integrity has become a key pillar of compliance with regulatory requirements, particularly within the Good Practice (GxP) frameworks (GLP, GCP, GMP, and others).
Starting from a selective focus on Good Documentation Practice (often referred to by the acronym ALCOA/ALCOA+), the expectation of high-quality and integrity-driven data and documentation is expanded to a holistic view. To this end, the concept of a “data lifecycle” is introduced and described in various regulations issued by different authorities and organizations.
These documents on data integrity, published only in the last few years, share significant commonalities, which is why the selection of two documents (OECD No. 22 and a 2018 document from the MHRA, the UK Medicines and Healthcare products Regulatory Agency) provides sufficient content to address the question of concepts and implementation options.
This will be presented in this seminar through the concept of "data governance" and practical examples of its implementation. The result will be improved or robust data integrity.
Terms and Conditions:
All information regarding reservations, registration, event materials, and certificates of attendance can be found in our Terms and Conditions for Open Events.
Who should attend?
- Employees in all GxP areas (GLP, GCP, GMP, GCLP, GDP, GVP, etc.) and from all departments that create, edit, modify, or even simply store data, documents, and documentation.
- Staff members at accredited (ISO 15189, ISO/IEC 17025, ISO/IEC 17020) or certified (ISO 9001, ISO 13485, others) laboratories who wish to learn about best practices for consistent and effective documentation, even though this is not a primary focus of the accreditation process.
- Anyone who wants to learn about and gain a deeper understanding of the framework for proper documentation of data, documents, and procedures, based on relevant regulations.
- Specifically, this applies to the following roles: testing/technical staff, test and project managers, employees in quality management, quality control, and quality assurance, archive managers, and employees in management positions
After your participation
- You will understand the reasons behind the growing emphasis on data integrity in regulatory oversight and will have become familiar with the key regulatory frameworks of various agencies and organizations.
- You have learned how the concepts of the data life cycle and data governance are conceptually linked and how their implementation leads to data integrity.
- Using numerous examples, you will learn how to implement best practices for paper-based and electronic documentation in your own processes.
Date:
June 17, 2026
Registration fee: €630.00 (€749.70 incl. VAT)
Online
Link to the event
Contact
Dr. Klinkner & Partner GmbH
Wilhelm-Heinrich-Straße 16
66117 Saarbrücken
Tel +49 (0) 681 / 982 10 – 0
Email:Click here
Web:http://www.klinkner.de