How to Manage a Product Medical Device Recall Efficiently and Effectively

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Description :

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.

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.

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 the 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

Who Will Benefit:
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. The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a “refresh” overview of the recall process from start to finish, including:

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

David R. Dills

David R. Dills, an independent Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the life sciences and FDA regulated industry, has an extensive regulatory background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses EU regulatory requirements regarding MDD and CE Mark. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and expertise.

This product is currently out of stock and unavailable.

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  • Presentation Handout in .pdf format
  • Presentation from the Speaker
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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance