Termin: 17. Juni 2026, Online
In recent years, data integrity has become an important pillar of compliance with regulatory requirements, especially in good practice regulations (GxP: GLP, GCP, GMP, others).
The expectation of good and integer data and documentation is expanded from the selective consideration of good documentation practice (often referred to with the acronym ALCOA/ALCOA+) to a holistic view. To this end, the concept of a "data lifecycle" is introduced and described in various regulations from different authorities and organizations.
These documents on data integrity, which have only been published in the last few years, have strong similarities, which is why the selection of two documents (OECD number 22 and a document from the MHRA, the UK Medicines and Healthcare products Regulatory Agency, from 2018) provides sufficient content for the question of concepts and implementation options.
This will be presented in this seminar using the concept of "data governance" and practical examples of its implementation. The result will be improved or good data integrity.
Conditions of participation:
All information on reservations, booking, event documents and certificates of participation can be found in our conditions of participation for open events.
Who should take part?
- Employees in all GxP areas (GLP, GCP, GMP, GCLP, GDP, GVP, etc.) and from all areas of responsibility who create, edit, modify or even just store data, documents and documentation.
- Employees in accredited (ISO 15189, ISO/IEC 17025, ISO/IEC 17020) or certified (ISO 9001, ISO 13485, others) laboratories who want to learn about information for consistent and good documentation practices, although this is not emphasized in the accreditation process.
- Anyone who wants to learn about and deepen their knowledge of the framework for good documentation of data, documents and documentation based on relevant regulations.
- In particular, the following roles are addressed: testing/technical personnel, test and project managers, employees in quality management, quality control and quality assurance, archive managers, employees in management functions
After your participation
- know the background to the increasing emphasis on data integrity in regulatory monitoring and have become familiar with the key regulations of various authorities/organizations.
- you have learned how the terms data life cycle and data governance belong together conceptually and lead to data integrity when implemented.
- you can use many examples to implement good documentation practice for paper-based and electronic documentation in your own processes.
Contents
Regulatory specifications and requirements
GxP and good documentation practice
Regulations and guidelines
Definitions of data types and other definitions
ALCOA/ALCOA+
The "data life cycle" and "data governance"
Good documentation practice (paper)
Handling of paper-based records
Creation of paper records
Changes/corrections to paper records
Copies and certified copies
Good documentation practice (electronic data)
Data life cycle
Audit trail and review
IT security
User management
Data storage
Electronic/digital signatures
Archiving
Archiving basics
Archiving paper documents
Archiving electronic data
Termin:
17.06.2026
Teilnahmegebühr: 610,00 € (725,90 € inkl. MwSt.)
Online
Link zur Veranstaltung
Contact
Dr. Klinkner & Partner GmbH
Wilhelm-Heinrich-Straße 16
66117 Saarbrücken
Tel +49 (0) 681 / 982 10 - 0
E-Mail: Please click here
Web: http://www.klinkner.de