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Complaint management and Medical Device Reporting (MDR) are critical quality systems for you to meet the needs of your 3 key stakeholders – the customer, the regulators, and your business. This medical device training 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.

Why Should You Attend:

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 also be an early warning of issues with your products and customer problems.

Areas Covered in this Webinar:

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

Learning Objectives:

The objective of this webinar is to have an efficient and effective process for managing, analyzing, trending, and reporting product problems. This session will also cover the basics of complaint management, regulatory requirements for medical devices and medical device reporting.

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

Speaker Profile:

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.

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.

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