Recalls & Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel

Website https://www.globalcompliancepanel.com/control/w_product/~product_id=600458?channel=mailer&camp=webin | Edit Freely

Category Health Care, Medical Device, Compliance Training

Deadline: May 19, 2011 | Date: May 19, 2011

Venue/Country: Wilmington, U.S.A

Updated: 2011-04-08 14:13:12 (GMT+9)

Call For Papers - CFP

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

Price List:

Live : $245.00

Corporate live : $995.00

Recorded : $295.00