Medical Device Recalls and Regulatory Enforcement

This webinar by Ms. Rita Hoffman, formerly FDA’s Branch Chief for CDRH Recalls, will cover FDA's expectations for a company conducting a recall and discuss the regulations which apply and provide guidance for if, when, and how a firm should prepare for and conduct a device recall.

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.

Who Will Benefit:

- Quality & Regulatory Professionals
- Design Engineers
- Product Managers
- CAPA Managers
- Public Relations
- Quality Managers

Event Details:
Date: November 08, 2012
Time: 10:00 AM - 11:00 AM PST
Cost: $299 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.

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.

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