Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on July 17 for a discussion of the webinar.

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 webinar will help you to understand the expectations of complaints 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 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.  

Webinar Takeaway

  • 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 

Who will Benefit

  • Complaint Specialists and Managers 
  • Individuals participating in Failure Investigations 
  • Individuals analyzing returned products / Complaint Analysis 
  • Regulatory Affairs 
  • Quality Engineers 
  • Clinical Affairs 
  • R&D engineers and scientists 
  • Compliance Specialists 

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty Susanne Manz

Faculty 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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices including roles as Worldwide Director of Design Quality, Worldwide Director of Product Quality, Executive Business Consultant, and Director of Corporate Compliance.  She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico.  She earned her Black Belt and Master Black Belt certifications in Six Sigma while at Johnson and Johnson. 

Choose a Purchase Options


Live Webinar - Single Participant 90-mins

You get one log-in for the live 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email


Recorded Access Single User-6 month Access

You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session


MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.


Live Webinar + Recording

You get one log-in for the live 90-minute webinar for one participant and Access to archived recording of the entire 90-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night.