FMDIC Public Workshop – June 15

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Medical Device Reporting, Complaints, and Recalls, Corrections, and Removals

Presented by the FDA Medical Device Industry Coalition

Are you troubled by what you see in the news? Have you struggled with how to handle complaints from your users while maintaining Regulatory Compliance?  Do you often wonder about what is reportable to the FDA? Do you feel prepared if you had to conduct a recall today? If any of these topics strike a chord, then plant to attend this educational forum to develop effective proactive strategies!

In a joint presentation by FDA, industry and academia, this workshop will provide critical information about FDA’s medical device regulations to the regulated industry and is tailored to small businesses, with an opportunity for Q&A with a panel of knowledgeable experts.  Topics include:

  1. Medical Device Reporting (MDR),
  2. The Role of Complaint Files,
  3. Recalls, Corrections, and Removals, and
  4. Corrective and Preventive Actions (CAPA) as it applies to complaints.

Date and Time:                                     Friday, June 15, 2012, 8 a.m. – 5 p.m.

Location:                                               Renaissance Dallas Hotel, 2222 Stemmons Freeway, Dallas, Texas, 75207.                                                                  http://www.marriott.com/hotels/maps/travel/dalbr-renaissance-dallas-hotel/

Registration: Register online using Visa, MasterCard, or American Express and secure your seat right now.

Registration Type

Early Registration Fee before 6/1/2012

Regular Registration Fee until 6/15/2012

General

$250

$300

Government with ID

$150

$200

Student with ID

$50

$75

For additional details on the event, please go to http://fmdic.org/events-training/mdr-complaints-recalls/  or contact David Arvelo, FDA, at  david.arvelo@fda.hhs.gov.

NOTE:  These workshops are very popular and registration is limited.  Be sure to sign up early to avoid being disappointed!  On-site registration will be available starting at 7:30 a.m. the day of the event. 

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