Date: 17.11.2022, Online
Data integrity has become an important pillar of "compliance" with regulatory requirements in recent years, especially in the Good Practice frameworks (GxP: GLP, GCP, GMP, others).
In this context, starting from the point-by-point view of Good Documentation Practice (often referred to by the acronym ALCOA/ALCOA+), the expectation of good and integrity data and documentation is extended to a holistic view. To this end, the concept of a "data lifecycle" is introduced and described in various regulations from different agencies and organizations.
These data integrity documents, published only in the last few years, have strong commonalities, which is why the selection of two documents (OECD number 22 and a 2018 document from the MHRA, UK Medicines and Healthcare products Regulatory Agency) 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 implementation. The result is then improved or good data integrity.
Conditions of participation:
You will find all information on reservation, booking, event documents and certificate of participation in our conditions of participation for open events.
Who should attend?
- Employees in all GxP areas (GLP, GCP, GMP, GCLP, GDP, GVP, etc.) and from all task areas 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 know information for consistent and good documentation practices, although the accreditation process does not emphasize this.
- All persons who want to learn and deepen the framework for their requirements for good documentation of data, documents and documentation, starting from 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 oversight and have become familiar with the key regulatory frameworks of various agencies/organizations.
- you have learned how the terms data life cycle and data governance conceptually belong together and, when implemented, lead to data integrity.
- you will be able to implement Good Documentation Practice for paper-based and electronic documentation in your own processes using many examples.
Contents
Regulatory guidelines and requirements
GxP and good documentation practice
Rules and guidelines
Definitions of data types and other definitions
ALCOA/ALCOA+
The "data life cycle" and "data governance".
Good documentation practices (paper)
Handling paper-based records
Creating paper records
Changes/corrections to paper records
Copies and certified copies
Good documentation practices (electronic data)
Data lifecycle
Audit trail and review
IT security
User management
Data storage
Electronic/digital signatures
Archiving
Archiving basics
Archiving paper documents
Archiving electronic data
Date:
November 17, 2022
Participation fee: 490,00 € (583,10 € 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
E-Mail: Please click here
Web: http://www.klinkner.de