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Essentials of Medical Device Reporting and Complaint Handling

3936
Duration : 90 Minutes

Susanne Manz,

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. She has a BS in Biomedical Engineerin Read more


Complaint management and Medical Device Reporting (MDR) are critical quality systems for a medical device company to meet the needs of its 3 key stakeholders – the customer, the regulators, and your business.   This webinar will help you to understand the expectations of complaint handling and medical device reporting.  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 complaints and MDRs.  In addition, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action).  We’ll cover best practices so you can be prepared for an FDA inspection.

Course Objective:

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 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.

Course Outline:

• Overview and Definitions
• FDA Expectations, Regulations
• Lessons Learned and Enforcement Case Studies
• Processes and Procedures
• Reportability Criteria
• Investigating a complaint or MDR
• Linkages between Complaint Handling, MDRs, and CAPA
• Common Mistakes and how to avoid them
• Best Practices
• Preparing for an FDA or NB Inspection

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Complaint Specialists and Managers
• Individuals participating in Failure Investigations
• Individuals analyzing returned products / Complaint Analysis
• Regulatory Affairs
• Quality Engineers
• Clinical Affairs
• Complaint Handling Unit Personnel
• Compliance Specialists

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

100% MONEY BACK GUARANTEED

Refund / Cancellation policy

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Subject : Essentials of Medical Device Reporting and Complaint Handling


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