RAPS Florida Chapter: Keys to Planning and Handling a Medical Device Recall

The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Product liability and financial risks are staggering when companies fail to properly report and take action when required. Firms need to voluntarily remove their regulated product that is either defective or potentially harmful by recalling that product and implement a compliant and effective recall program. This program should include removing it from the market or correcting the problem, which is the most effective means for protecting the public.  A properly handled recall program can minimize the risk of major FDA enforcement activities and minimize further expensive product liability risks.

Join colleagues from your local regulatory community to hear an interactive presentation from former CDRH recall branch chief, Rita Hoffman, RAC. The presentation will provide an overview of FDA's expectations for companies conducting recalls, the regulations that apply and provide guidance for if, when, and how a firm should prepare for and conduct a device recall.

 Continental breakfast will be available. RAC holders can claim two RAC recertification credits.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Speakers
  • Registration Info
  • Cancellation

At a Glance

Date:

Thursday, 16 March 2017 (8:00–10:30 am EST) 

Location:

Jabil
Pasco Building, Conference Room A
805 Executive Center Drive West
St. Petersburg, FL 33702

Directions are available online or by calling +1 727 577 9749. 

RAC Credits:

Two RAC certification credits upon completion of the program 

Registration Fees:

Prior to 10 March
RAPS members: $20
List: $30 

 

On or after 10 March
RAPS members: $30
List: $40

Objectives

At the conclusion of this program, you’ll have a better understanding of:

  • What FDA means by the term “recall” 
  • The essential elements to help firms understand the difference between a medical device recall, market withdrawal and safety alert 
  • How to implement an effective voluntary recall program
  • Identifying the problem and cause of the recalling produc
  • Know the timeframes for submission of an 806 (Correction and Removal Report
  • What is CDRH’s Health Hazard Evaluation Process
  • What to do if your firm has a Class I recall
  • The common mistakes companies make when recalling products
  • How to implement a corrective action program for a recall 
  • How to implement an effective audit program
  • Who, how and when to notify the FDA of a recall situatio
  • What FDA can do when a firm is reluctant to conduct a recall
  • Effective communication with FDA district recall coordinator
  • Steps in an effective course of action during a recall
  • How to implement an effective recall strategy
  • The definition of a “silent” recall
  • The best ways to effectively communicate with FDA headquarters

Agenda

Thursday, 16 March 2017 (8:00–10:30 am EST)

8:00–8:30 am             Breakfast, Networking and Introductions

8:30–10:30 am           Speaker Presentation and Q&A Session

Speakers

Rita Hoffman, RAC, principal consultant/owner, Regs & Recall Strategies, LLC

Registration Info

Prior to 10 March 2017
RAPS members: $20 
List: $30 

On or after 10 March 2017
RAPS members: $30 
List: $40 

>> Registration Online

>> Registration Form (PDF) – for registration by mail or fax.

Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contact

Jan Flégeau, chair, RAPS Florida Chapter

Wesley Carr, senior program manager, chapter and volunteer relations, RAPS

 

 

 

Cancellation

RAPS is not able to accept cancellations by phone. All requests for cancellation must be received in writing or by calling customer service. Supporting documentation is required and must be received by the deadline specified. Chapter events with registration fees less than $100 will not be refunded. For events that exceed this amount a 20% cancellation fees will be assessed.

 

Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email, to raps@raps.org

 

Substitutions may be accepted with written approval from RAPS.