Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical they are frequently inspected areas by the FDA. More importantly, complaints can be also be an early warning of issues with your products and customer problems. It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. This webinar will cover the basics of complaint management and medical device reporting. Complaint management and MDRs are critical quality systems to your 3 key stakeholders - the customer, the regulators, and your business.
Why should you Attend?
Complaint Handling and Medical Device Reporting are essential processes to ensure the safety and efficacy of your medical devices. As such, they are also frequently inspected by the FDA. It is critical that you understand and create efficient and effective processes.
Who will benefit?
This webcast will be of a valuable assistance to the below audience.
Susanne Manz, MBA, MBB, RAC, CQA 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
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