ComplianceOnline

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

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification

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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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 by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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Payment:

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions for In-person Seminars:

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 before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

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.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
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