Date : Tuesday, June 21, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 60 Minutes Price : $245.00
Live Webinar Recalls & Vigilance - When to Report Complaints
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: l l l l l l l
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
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Register Now Instructor Profile: John Chapman Regulatory Affairs Professional
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. ...more
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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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