Live Webinar on
Regulatory Complaint Handling, MDR's & Recalls
Course "Regulatory Complaint Handling, MDR's & Recalls" has
been pre-approved by RAPS as eligible for up to 1.00 credits
towards a participant's RAC recertification upon full completion.
Date & Time:
Wednesday, August 01, 2012 10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes Instructor: John Chapman John Chapman
Location: Online Price : $245.00 (for one participant)
John Chapman, BS, MBA, RAC has
over 30 years medical device
Medical device firms need to be aware of the benefits of compliance regulatory experience and over 10
a s well as the dangers of inadequate complaint handling. This years experience with the European
Webinar will explain the regulatory process and in understandable Union's medical device directive,
terms. 93/42/EEC. John has led two device
companies to ISO quality system
certification and CE marking. He has
Many medical device firms face regulatory issues as a result of
been performed regulatory due
inadequate complaint handling. FDA has explicit complaint handling diligence on over a dozen
requirements and poor complaint & reporting procedures often result acquisitions in the past 12 years,
in costly recalls and warning letters. FDA warning letters and recalls exposing him to numerous quality
are posted on FDA's website and published in trade magazines, systems, including consent decrees
newspapers available to firm's competitors, and has even driven the as well as many notified bodies. He
firm's stocks down. This presentation will review the regulations and earned his regulatory affairs
certification (RAC) in 1998 and was a
point out some of the pitfalls in complaint handling and reporting.
contributing author to 2004
Fundamentals of EU Regulatory
Areas Covered in the Session: Affairs, RAPS, 2004. He co-founded
a local RAPS chapter and has been a
speaker at these meetings and the
l FDA's Complaint Definition 820.3 (b). annual RAPS conference. ...more
l Complaint Documentation.
l Part 803 - Medical Device Reporting.
l Part 806 - Reports of Corrections & Removals.
Suggest a Topic More Webinars
l Warning letters and other FDA Remedies.
l Complaint Handling Pitfalls. Your Necessity is our Priority
Click here to register for this webinar
Who Will Benefit:
Some employees who wish to gain a better understanding include:
l Quality & Regulatory Professionals
l Manufacturing & Design Engineers
l Marketing Product Managers
l Corporate & Operations Executives
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.
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