Back to list

Regulatory Affairs for Managers

Categories Software-Development for Medical Products

General Information
Code
RF
Duration
1 Day

Quality is a task for management. Quality guidelines must be implemented and actively put into practice. Most importantly, this requires specialized knowledge, a sense of responsibility at the highest level and a solid understanding of the regulatory stipulations along with the company's own processes and organizational structure.

To create a solid foundation here, the seminar will first introduce the regulatory lifecycle models from two industrial areas, medical and pharmaceutical technology, with their respective objectives with regard to product safety. The seminar will cover which regulatory specifications with regard to software are absolutely relevant and which basic procedures must be implemented in the company and in the project in order to meet these requirements. This will result in a unified, risk-based procedure model for software development that applies for both sectors and that will be given to participants as a reference for successfully navigating the next audit.

The seminar is appropriate for experienced managers and managers in specialized areas, who wish to obtain a solid, concise overview of all of the relevant regulatory requirements; however, the seminar also offers an initial introduction to the subject of software in a regulated environment.

Contents
  • Regulatory landscape (medical technology/pharmaceuticals/chemistry – USA/EU)
  • Overview of the responsible parties (legislation, agencies, institutes, etc.)
  • Current and upcoming changes in the legal situation
  • QM systems
  • Harmonized software lifecycle
  • Risk management
  • CAPA
  • Special issues with regard to 21 CFR Part 11 and EU GMP Annex 11
Target audience

Managers, safety/security administrators, quality representatives, testing material administrators, project managers and IT directors in the specialized areas of medical technology, pharmaceuticals and biotechnology, who have responsibility for the application and /or development of software

Prerequisites
  • None

Any Questions?

Any questions about our engineering service offers? Feel free to call us!

Contact card image

Susan Helm

+49 9131 97206-556
Contact card openContact card close
General Terms & Conditions
Download (pdf, 165 KB)
Courses 2018/19
Download (pdf, 4 MB)