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.

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, 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?
• 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.

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.