Description

Summary: Regulatory and compliance continuing education provider, GlobalCompliancePanel will hold a RAPS-approved webinar on July 17. Participants at this course will earn 1.5 RAC points and become eligible for RAC recertification upon full completion. The webinar will be presented by David R. Dills; an independent Regulatory & Compliance Consultant on the topic “Construct and Manage the Technical File and Design Dossier”.

Description: There exist significant differences between the components and ingredients for a Technical File and a Design Dossier for device manufacturing firms. Depending on the class of devices a firm manufactures; differing kinds of Design Dossiers and Technical Files have to be prepared, taking into consideration the nature of information needed to be assembled. There will also be a difference between these two kinds of documentations based on the complexity of the CE marking on thedevice

The webinar will benefit
o Regulatory Affairs/Regulatory Affairs Specialists
o Clinical Affairs
o Quality and Compliance
o Marketing & Sales
o Distributors
o Engineering/Technical Services
o Consultants


Benefit:
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.