UPCOMING WEBINAR Complaint Handling and Post Market Management – How to Comply with Global Regulatory Requirements
May 29th, 2025 // 5:14 pm @ jmpickett
Summer 2025, Date TBD
Jackelyn Rodriguez, President Monarch Quality Systems Solutions
FDA investigators consider how a medical device company handles complaints to be an important indicator of a manufacturer’s overall state of control of their Quality System— if the complaint and MDR systems are not in a “state of control,” chances are the rest of the quality system is out of compliance. The first of the ten most common reasons for FDA 483 Observations and Warning Letter citations are related to instances of inadequate complaint handling procedures.
Compliance with the regulations related to product complaints can be a huge challenge. This 90-minute webinar will help companies solve the most common and most difficult product complaint and MDR issues.
Part I:
Analyzing the Definition of a Complaint in 21 CFR 820.198
According to the FDA, a complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. This presentation will review the definition of a complaint and will outline an effective complaint handling system.
- Learn how to evaluate a complaint to determine if an MDR or a Recall is required
- Determine if an investigation is necessary — what are the requirements for designated units and designated investigators?
- What are the key issues related to Post Market
Part II:
Servicing Can Lead to Complaints — an In-Depth Look at 21 CFR 820.200
The FDA cites the quality system regulations 21 CFR 820.200 in warning letters that connect service reports to what they consider unreported complaints. The regulations require that medical device manufacturers must create and maintain records each time they service a device. This presentation will review statistical techniques that can be used to analyze service reports.
- Learn how individual service reports can lead to complaints and MDR’s
- What service personnel should be looking for to identify product complaints when they interact with consumers
Part III:
Front Line Employees — Recognizing Customer Interactions as ComplaintsThe FDA expects firms to train all of their employees to recognize and report product complaints. In two recent warning letters, the FDA cited a company for their failure to train their front line employees on product complaint reporting. This presentation will define steps companies should take to make sure their sales and service people recognize potential complaint and MDR events and report them correctly.
Attendees will:
- Learn how to train the sales force and other customer-facing employees to recognize and report complaints
- Establish guidelines for customer service representatives to be able to handle complaints
