How to Manage a Medical Device Recall Efficiently and Effectively 2013

Topics

• Understand what are effectiveness checks
• Create and use a recall operational procedure and what should it contain
• Learn why a recall is either a correction or a removal depending on where the action takes place
• What happens in a medical device recall
• Medical device recall authority and guidance
• Understand why is required for the recall strategy as expected by FDA
• Understand why the documentation and paper trail are so critical and termination of a recall
• Depth of recall and using a viable, sustainable and effective strategy

Who should Attend

• Clinical Affairs
• Regulatory Affairs
• Marketing & Sales
• Quality and Compliance
• Legal Counsel
• Distributors/Authorized Representatives
• Consultants
• Engineering/Technical Services/Operations