22 June 2016
5:30–8:30 pm
Babson College Executive Conference Center
Babson Park, MA
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.
To clarify medical device recalls and the role of the manufacturer in these actions, Rita Hoffman, RAC, will be providing you with FDA's expectations for a company conducting a recall, discuss the regulations which apply and provide guidance for if, when, and how a firm should prepare for and conduct a device recall.
What you’ll learn:
- 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 product
- 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 situation
- What FDA can do when a firm is reluctant to conduct a recall
- Effective communication with FDA district recall coordinators
- 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
A full dinner buffet will be provided for program attendees and those who hold the RAC may claim two RAC recertification credits.
This event is sponsored by the RAPS Boston Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals.
Date/Time:
Wednesday, 22 June 2016
5:30–6:30 pm Registration, Check-in, Networking and Dinner
6:30–8:30 pm Speaker Presentation and Q&A Session
Location:
Babson College Executive Conference Center
One Executive Education Circle
Overlook Dining Room
Babson Park, MA 02457
Get directions online or call +1 781 239 4000
Registration:
Prior to 15 June
RAPS Members: $50 Nonmembers: $65
On or after 15 June
RAPS Members: $60 Nonmembers: $75
» Registration Form (PDF) - for registration by mail or fax
Speaker:
Rita Hoffman, RAC is the principal consultant/owner of Regs & Recall Strategies, LLC, a consulting firm providing regulatory insight focusing on industry assistance on FDA compliance issues. Hoffman has been consulting with FDA firms on post marketing issues for the past four years.
Prior to working as a consultant, Hoffman spent more than 36 years with the FDA. She retired in 2011 after holding the position of recall branch chief for the Center for Devices and Radiological Health (CDRH). She was responsible for oversight and review of all medical devices recalls with extensive knowledge of the legal authority of 21 CFR Parts 7 & 806, 803 and 820 of the Act. During her tenure with FDA, she served in several critical headquarter positions including: compliance officer, ombudsman, jurisdictional review officer, small business liaison and policy analyst.
Hoffman continues to collaborate with industry as an expert advisor and remediates on regulatory subject matters including drug/device for recalls, GMP and quality systems inspections/regulations, field safety alerts for drug products, MDR and complaint handling and other matters. She has been hosting trainings with various FDA Regulatory Groups for over four years on complaint handling, MDRs and recalls.
Local Contact:
Sue Haman, RAC, chair, RAPS Boston Chapter
RAPS Contact:
Wesley Carr, senior program manager, chapter and volunteer relations, RAPS, +1 301 770 2920