MD 2013 - How to Manage a Product Medical Device Recall Efficiently and Effectively

Creating an effective Product recall process that will protect both the consumer and company's/brand's reputation requires careful planning and active involvement of each involved department.
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.

Areas Covered in this Session:

• Create and use a recall operational procedure and what should it contain
• Understand what are effectiveness checks
• What happens in a medical device recall
• Learn why a recall is either a correction or a removal depending on where the action takes place
• Understand what is required for the recall strategy as expected by FDA
• Medical device recall authority and guidance
• Depth of recall and using a viable, sustainable and effective strategy
• Understand why the documentation and paper trail are so critical and termination of a recall
• Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming