6-Hour Virtual Seminar

Medical Device Recall Management

BY: Susanne Manz, President and Principal Consultant, Manz Consulting Inc

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

September 23, 2020
(11:00 AM to 5:00 PM EDT)
Virtual Seminar
  • Course Description
  • Agenda
  • Speaker
  • Price/Register

Despite best efforts, serious quality issues resulting in a recall can occur. Medical Device companies need to be prepared in advance to handle the difficult situation. This 6-hour virtual seminar will prepare you to understand the signals that trigger a need to recall, the investigation and other actions required, taking corrective and preventive action, and notifications to customers and regulatory bodies.

Why You should 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.

You will understand the regulatory requirements for dealing with a medical device recall. You’ll learn about FDA expectations and regulations as well as lessons learned from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage failure investigations, recalls, and take appropriate corrective and preventive action. In addition, we’ll discuss how to link these processes link to other parts of your Quality Management System. We’ll cover best practices so you can be prepared for a possible post-recall FDA inspection.

Areas 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
Who will Benefit:
  • Complaint Specialists
  • Compliant Handling Unit staff
  • Medical Device Reporting staff
  • Individuals participating in Failure Investigations
  • Individuals analyzing returned products / Complaint Analysis
  • Regulatory Affairs
  • Quality Engineers
  • Clinical Affairs
  • Compliance Specialists
  • Quality Managers
  • Management Representatives
September 23, 2020(11:00 AM to 5:00 PM EDT)
  • 11:00 AM- 12:30 PM Definitions and Sources
    • Linkages between Complaint Handling, Adverse Event Reporting, Non-conforming Material, Recalls, and CAPA
    • Triggers of Recalls
    • Recall Types and Classification
    • Complaint Handling and Medical Device Reporting
  • 12:30 PM- 1:00 PM Lunch Break
  • 1:00 PM- 2:30 PM Non-conforming Material Control
    • Failure Investigation
    • Corrections and Removals
    • Corrections and Removals
  • 2:30 PM- 2:45 PM Break
  • 2:45 PM- 4:45 PM Corrective and Preventive Action
    • Risk Management
    • Lessons Learned
    • Challenges, Preparing for an FDA Inspection
  • 4:45 PM- 5:00 PM Question and Answer
Susanne Manz
Susanne Manz President and Principal Consultant, Manz Consulting Inc

Susanne Manz, MBA, MBB, RAC, CQA 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. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and 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. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

Register Now

Online using Credit card

$1,599.00

(One Dial-in One Attendee)

September 23, 2020, Virtual Seminar

$8,155.00

Group-Max. 10 Attendees

September 23, 2020, Virtual Seminar


For discounts on multiple registrations, contact customer care at +1-888-771-6965.

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Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@grcseminars.com

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

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