This webinar will provide a step-by-step procedure to all medical device companies that need to bring their product design history files up to date with current standards.
Why Should You Attend:
Many regulated companies have not brought their old products up to current FDA standards and are not in total compliance. This webinar defines the criteria to be used for medical products design history file remediation.
For example companies should be compliant to 14971:2007. Design History Files need to be updated to meet current standards. The FDA expects risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. Each product needs to have a gap analysis to determine obsolescence or validate. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.
Date: August 16, 2012
Time: 10:00 AM-11:00 AM PDT
Cost: $249 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
Added by complianceonlinecom on August 8, 2012