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.
This webinar will help you to 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.
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.
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
- 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
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, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne 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 Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.