2012 - Liv webinar on How to Manage a Medical Device Recall Efficiently and Effectively By Compliance2go

Why should you Attend:

? Create and use a recall operational procedure and what should it contain
? Understand what effectiveness checks are
? 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
? Source of 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
? Snapshot of most recent recalls and why the numbers are alarming

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Description of the topic:

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. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.

Who will benefit: (Titles)

Manager, Regulatory
Director, Regulatory
Legal Counsel
Regulatory Affairs Specialist
Marketing and Sales Management
Regulatory Consultants

About Speaker

David R. Dills, Principal Consultant, PES-RAQA, Medical Device Practice, Wipro Technologies, currently provides regulatory and compliance consultative services to global medical device and pharmaceutical manufacturers, and also has an accomplished record with more than 23 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of QA, Regulatory Affairs and Compliance.
Since 2000, has provided consultative services on behalf of global manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process, inspection readiness preparation, GxP/strategy/risk management, audits and regulatory assessments, remediation and regulatory strategies, postmarketing surveillance/vigilance reporting, clinical affairs, deploy and remediate Quality Management and documentation systems, preparation for ISO 13485 registration and CE Mark, and multi-country product registrations and licensing. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.