Date:
February 16, 2027, Online
Dated signatures are required as a key documentation element in all quality (management) systems in accordance with Good Documentation Practice. At the same time, they are also necessary for many activities in our daily lives—we sign contracts, letters, and much more.
Due to digitalization in all areas of our lives, the traditional, manually executed signature (“wet ink signature”) is increasingly being replaced by electronic variants—both in regulated quality systems and through requirements in generally applicable laws such as EU Regulation (EU) No. 910/2014.
The aim of the seminar is to present the dated signature within the framework of GxP- or ISO-standard-regulated quality (management) systems, both in the traditional form as a manual signature and in the electronic form as an electronic signature. The latter is presented in the context of the requirements of U.S. law 21 CFR Part 11 and the European Regulation (EU) No. 910/2014. The implementation within the quality (management) system is explained using examples.
Who should attend this seminar?
Employees of all quality (management) systems (GxP-regulated or ISO-standard-regulated) who wish to learn about or deepen their understanding of the handling of dated signatures
Employees who are responsible for defining the rules for handling signatures within their organizations, e.g., quality managers, IT managers, and employees in leadership positions
After the seminar
You will understand the significance and use cases of dated signatures in quality (management) systems.
You have learned the regulatory fundamentals regarding signatures in regulated quality (management) systems.
You have internalized the rules for handling manual signatures (“wet ink signatures”).
You have learned about the concept of electronic signatures.
you have learned about the legal regulations governing electronic signatures (21 CFR Part 11 and (EU) 910/2014) and the different levels of electronic signatures contained therein.
you have learned about a concept for introducing electronic signatures in your organization, thereby making them equivalent to manual signatures.
You can find the program here.
Date:
February 16, 2027
Registration fee: €630.00 (€749.70 incl. VAT)
Online
Contact
Dr. Klinkner & Partner GmbH
Wilhelm-Heinrich-Straße 16
66117 Saarbrücken
Tel +49 (0) 681 / 982 10 – 0
Web:http://www.klinkner.de