Medical Device Recalls and Regulatory Enforcement November 7, 2012

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.
Developing and recognizing a crisis, when to go into crisis mode and 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.

Who Will Benefit:

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

Official Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702421?channel=yahooevent