Did you know that your career can be ruined, or you can even do jail time, in a product recall?
It has happened. Read here. And here. All FDA and DOJ have to show is that you ‘should have known’ about problems with your product. “I didn’t know” is NOT a defense!
That low standard means that companies under recall want to pay and settle quickly. Guess what? That means you can be thrown under the bus. It means your career can be destroyed in a flash.
Avoid this!
Learn the latest about medical device and drug recalls and the role of the manufacturer in these actions. In this Webinar, you will discover:
- FDA’s expectations for a firm under recall.
- Details about the regulations that apply, and provide guidance for if, when and how a firm should prepare for and conduct a device or drug recall.
- What steps to take under a drug recall – Rita spent 10 years at CDER and has a great deal of knowledge on drug subjects as well, and how recalls are handled with drugs.
What You Will Learn:
• What FDA means by the term “Recall”
• The essential elements to understand the difference between a Medical Device Recall, Market Withdrawal & 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)
• The basics of CDRH’s Health Hazard Evaluation Process
• How to develop an plan for effectiveness checks
• What to do if your firm has a Class I recall
• How to develop effective Standard Operating Procedures for recalling your product
• How to recognize a crisis, when to go into crisis mode and what to consider when forming your crisis management team
• The common mistakes companies make when recalling products
• How to implement a corrective action program for a recall
• Points to include in an effective notification letter
• 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
• What to look for during manufacturing process to help avoid a recall situation
• 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
NOTE: All Webinars are eligible for 1.0 credits towards your RAC certification and 0.1 credits towards your ASQ certification.
What You Will Receive:
• Tools and mechanisms to assist you with understanding the recall process
• Links to pertinent FDA requirements
• Examples of medical device recalls
• Enforcement plans by FDA
• Practical advice from an experienced and respected expert
• Time for questions and answers
Background:
In June 2011, the Government Accountability Office released the report “Medical Devices: FDA Should Enhance Its Oversight of Medical Device Recalls.” This report assures that device firms will face increased scrutiny from FDA of any recalls – and reinforces the need for device firms to be on top of the regulations defining responsibilities before, during and after a recall.
Between 2005 through 2009, there were 3,510 medical device recalls – an average of just over 700 per year. But what IS a recall? Devices were also removed from sale as a result of “Safety Alerts” and “Market Withdrawals.” Are those recalls? The terms sound similar – are manufacturer obligations, FDA involvement, and severity of regulatory consequences also similar? It’s not surprising that companies are sometimes confused by what a medical device recall actually entails.
Regular Price $349 – Click Link Below to See New Low Sale Price!
Who Should Attend:
• Management
• Regulatory affairs professionals
• Quality assurance/quality control personnel
• Auditors & inspectors
• Operations & manufacturing personnel
• Legal staff
Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter
- Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)
About the Presenter
Rita Hoffman recently retired as the Recall Branch Chief for the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), responsible for the oversight and review for all medical device recalls submitted for health risk classification. Ms. Hoffman provided guidance to FDA District Recall Coordinators on recall recommendations initiated by regulated industry and on recall strategy (Recall Depth, Effectiveness Check, and Audit Check), Health Hazard Evaluations, recommendations and legal authority. In more than 30 years with FDA, Ms. Hoffman has worked on many aspects of agency compliance and policy in the areas of drugs, devices and veterinary products. Prior to joining CDRH, she was the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer, providing guidance on drug/device product designation, combination products and co-packaging. In addition, she was involved in regulatory compliance in the area of pharmacy compounding. Rita has held various other positions within CDER including Acting Associate Ombudsman, Small Business Liaison, serving as primary contact for inquiries from the ORA Small Business Reps, as well as working as a Policy Analyst for eight years in the Office of the Commissioner. During her tenure with FDA, Ms. Hoffman has received a number of FDA awards including the Leveraging and Collaboration Award, Commendable Service Awards and Outstanding Recognition Awards. In 2008, Mrs. Hoffman received the Regulatory Affairs Professional Society Special Recognition Award recognizes unique contributions and achievements of individuals and organizations that advance the quality of health and regulatory affairs. In addition to her work with FDA she served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter, working in collaboration with both chapter members and FDA to increase professional awareness of regulatory issues. Ms. Hoffman holds a BS in speech pathology and audiology from the University of Maryland, advanced courses in Chemistry and Public Policy and is Regulatory Affairs Certified. Rita R. Hoffman,RAC formerly the Branch Chief CDRH Recall Branch, HFZ-306 Division of Risk Management Operations Office of Compliance Center for Devices and Radiological Health (CDRH).