The Design History File - documenting Product Design Control and its nine elements
The Design Control requirements of the CGMPs, 21 CFR 820.30
The EU’s Medical Device Directive
The Device Master Record and the Device History Record
The remaining elements of a Technical File / Design Dossier
The "Essential Requirements"; and their documentation
Two attendee projects
Trends
Who should Attend
Regulatory Affairs
Senior and middle management and staff
R&D
QA/QC
Manufacturing Engineers
Production Management
Project Managers
Process Engineers
Any tasked with medical device development, documentation, and regulatory responsibilities
Vendors, sales and marketing
Past Events
DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements 2014 - 14-15 Aug 2014, Hilton Grand Vacations Suites at the Flamingo, Las Vegas, Nevada, United States (45961)
Please, check "DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Healthcare, Medical device, Pharma
