Overview: This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints.
FDA has issued warning letters for failing to properly evaluate medical device complaints for reporting under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firms' competitors.
Areas Covered in the Session:
* Complaint definitions - FDA, Canada & Europe
* FDA's complaint handling requirements
* Canada & European Union complaint handling
* FDA's voluntary & mandatory reporting
* 21CFR 803, 806 & 810 explained
* FDA regulatory actions against firms
* Adverse event reporting - Canada & Europe
Who Will Benefit:
* Design Engineers
* Regulatory Professionals
* Technical Writers
* R & D Managers
* Design Engineers
* QA Managers
FDA has issued warning letters for failing to properly evaluate medical device complaints for reporting under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firms' competitors.
Areas Covered in the Session:
* Complaint definitions - FDA, Canada & Europe
* FDA's complaint handling requirements
* Canada & European Union complaint handling
* FDA's voluntary & mandatory reporting
* 21CFR 803, 806 & 810 explained
* FDA regulatory actions against firms
* Adverse event reporting - Canada & Europe
Who Will Benefit:
* Design Engineers
* Regulatory Professionals
* Technical Writers
* R & D Managers
* Design Engineers
* QA Managers
