FDA Commissioner Margaret Hamburg has taken steps to improve the effectiveness of FDA's enforcement system. As a result, medical device firms are reporting that FDA investigators are being more assertive when inspecting firms, increasing the number of 483 observations and issuing more warning letters.
On October 5 - 6, AdvaMed is holding a workshop, "Avoiding a Warning Letter in FDA's New Enforcement Environment," in Washington DC. During the workshop, current and former FDA officials, lawyers, and industry representatives will describe tools to help you avoid 483 observations and warning letters. They will also provide guidance on how to respond to a warning letter should you get one.
What You Will Learn:
* FDA's criteria for issuing 483s and warning letters
* What to do when FDA makes an unorthodox request for records
* Do's and don'ts for handling an FDA inspection
* How to respond when FDA lists numerous insignificant items on a 483
* Ways to avoid common mistakes when annotating a 483
* How to conduct effective training
* How to determine FDA's inspection priorities using FOI
* Tips for creating CAPA records that reflect your commitment to compliance
* How to respond to 483s and warning Letters
Faculty:
* David R. Kalins, Special Assistant to the Director of the Office of Compliance, CDRH
* Betty Collins, former Director, FDA's Office of Enforcement 2
* Marlene Bobka, Vice President, FOI Services
* Judy Meritz, Shareholder, Baker Donaldson
* Tim Mohn, former Manager, Worldwide Quality Systems, Ortho-Clinical Diagnostics
* Nicole Petty, Senior Manager, Learning & Development, Stryker Instruments
* Javad Seyedzadeh, Senior Vice President Global Quality, Gambro
* Nancy Singer, former Special Counsel, AdvaMed
Cost:
$1195 AdvaMed members
$ 695 AdvaMed EGC member (less than 30 million in sales)
$1595 Non-member of AdvaMed
For more information go to:
