Discover how the Accugenix Track and Trending tool aggregates critical EM data



GMP for Medical Devices


2014, October 1 - 2

» Training


The aim of the course is to identify similarities and differences between the regulations of the FDA and the European regulations for Medical Devices. The focus will be on

Certification Procedures
Technical Documentation vs Device History File and Device Master Record)
Design Controls
Validation /Qualification
Regulatory Audits
CAPA and Complaint Handling

A Notified Bodiy representative will start the course by explaining the regulatory requirements.

In the further presentations articular attention will be paid to findings made during FDA inspections.

3 Parallel workshops – concentrating on technical documentation, preparing a FDA inspection and audit findings – will provide practical orientation.


Venue

NH Heidelberg
Bergheimer Strasse 91
Heidelberg,
69115
Germany

Organizer

Concept Heidelberg
Phone: +[49] 62 21/84 44 0
Email: info@concept-heidelberg.de
Visit organizer website



© 2001 - 2017 Rapid Test Methods Ltd • Please join us on Twitter, Facebook and LinkedIn • RSS Feed