ComplianceOnline, Online Event
2012-11-08
Why Should You Attend: When an FDA-regulated product is either defective or potentially harmful, recalling that product by implementing a compliant and effective recall program, that includes removing it from the market or correcting the problem, is the most effective means for protecting the public. Properly handled, a recall program can minimize the risk of major FDA enforcement activities and minimize further expensive product liability risks.
During this session, Ms. Rita Hoffman, formerly FDA’s Branch Chief for CDRH Recalls, will clarify medical device recalls and the role of the manufacturer in these actions. In this training, you will be provided with FDA's expectations for a company conducting a recall. We will also 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 will get: - 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 panel.
- Time for questions and answers.
Event Details: Date: November 08, 2012 Time: 10:00 AM-11:00 AM PDT Cost: $299 per attendee per computer terminal Registration: SIgn-Up on-line now. Add to your shopping cart. |
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Invited Speakers:
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Rita Hoffman, RAC. Managing Partner RHoffman, Inc. Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products.
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