3-Hour Virtual Seminar on Complaint Handling and Medical Device Reporting and Recalls

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Nov 13, 2023, 14:45 ET

DUBLIN , Nov. 13, 2023 /PRNewswire/ -- The "3-Hour Virtual Seminar on Complaint Handling and Medical Device Reporting and Recalls" webinar has been added to ResearchAndMarkets.com's offering.

This webinar will help you to understand the regulatory requirements for dealing with a medical device recall.

Prepare your medical device company to handle serious quality issues and recalls with this 3-hour virtual seminar. You'll gain insights into recognizing signals that trigger the need for a recall, conducting investigations, and taking corrective and preventive actions. Learn about FDA expectations, regulations, and lessons from 483s and warning letters.

This seminar will also help you develop efficient processes for managing failure investigations, recalls, and linking them to your Quality Management System. Discover best practices to prepare for post-recall FDA inspections and ensure your company is well-prepared to navigate these challenging situations. Don't miss this opportunity to enhance your recall preparedness and compliance.

Why Should You Attend:

A quality issue resulting in a recall is a serious issue for a medical device company. A company's actions must be commensurate with the risk of such a serious issue. A recall can be a time of great pressure with a need for urgent investigation and actions. It is best to have procedures ready in advance in order to handle all activities in a diligent and compliant manner. Don't try to figure it out as you go along.

Additionally, a recall can trigger a regulatory inspection and enforcement actions. This webinar will cover these possibilities and how you can best prepare for them. A recall is always a difficult situation but having good procedures and processes in place can help you do the right thing to protect your customers.

This webinar can help you ensure you are ready in the event of a recall-initiated, for-cause inspection.

Key Topics Covered:

Regulatory Expectations
Medical device authority and guidance
Complaint Handling, Medical Device Reporting, and Recall requirements
Recall Types and Classifications
Failure Investigation
Difference between a product enhancement and a recall
Roles and responsibilities
Non-conforming material control
Recall strategy and FDA notification
Required Communications
Firm's MDR reporting and FDA's handling of MDRs
Lessons learned and enforcement case studies
Processes and Procedures
Linkages between Complaint Handling, MDRs, Recalls, and CAPA
Corrective and Preventive Action
Minimize your risk of regulatory actions
FDA's new guidance on risk
Preparing for an FDA Inspection

Speaker

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma.

She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.

For more information about this webinar visit https://www.researchandmarkets.com/r/89jkzf

About ResearchAndMarkets.com
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SOURCE Research and Markets