2015 - Webinar On Conformance of Design History Files for Mature Medical Devices

Description :
This webinar on Design History Files (DHF) will provide a step-by-step procedure for all medical device companies that are in need of bring their product design history files up to date with the current standards.
Many medical industry companies have not brought their old product lines up to current FDA standards and are not in total compliance. This webinar defines the procedures to be followed for medical products design history file remediation.
Areas Covered in the Session :
Multi-functional team approach/responsibility.
Set procedures and template to complete remediation for design history file of old devices to meet current standards.
Gap analysis
Data gathering to build the design history files
Risk procedure
Risk assessment for prioritizing remediation
Validations
Dealing with the FDA
Phase by phase check list.
Who Will Benefit:
This webinar will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with current standards. The employees who will benefit include:
Senior management
End-users responsible for design control and technical files that need to be updated to the current standards
R&D and product development
Process engineers and managers
Operations and plant management
Validation engineers
Remediation teams
Documentation teams
QA, Regulatory Affairs
QC and Corporate Auditors
All team members who contribute to design history, clinical, validations or technical files
Consultants
All Contract Manufacturers working in the medical industry