Medical Device Complaint Handling, Event Reporting, and Recall Management Training

What You Will Learn

At the conclusion of this workshop, you will be able to:

• Assess customer feedback scenarios using the FDA definition and ISO 13485:2016 criteria to correctly identify alleged deficiencies, complaints, and potentially reportable events, and write effective problem statements.
• Discuss complaint-handling unit strategies and best practices to better integrate the function within the organization, measure its effectiveness, and add value to management review.
• Analyze complaint investigations to accurately determine appropriate next steps: closure or escalation to Level III investigation to root cause, and reportability.
• Discuss post-production risk evaluation team formation, applicable forms, tools, timing, necessary information, and impact assessment. Review the types of incidents to document in a risk management SOP.
• Use a global reportability matrix to decide full reportability obligations for events. Follow the process steps required to practice submitting a report in jurisdictions identified, using required documents.
• Prepare for an audit of the complaint-handling system by understanding and interpreting the reporting requirements in the US, EU, Canada, China, Japan, Brazil, and Australia and discussing best practices for third-party audits.
• Apply a risk-based approach to needed corrections and removals by practicing the risk assessment process leading to a recall decision.
• Identify postmarket surveillance requirements, including those in the new EU Medical Device Regulation.

Who Should Attend

This course is designed for complaint processors, complaint-handling unit organizers, and those who work closely with them to meet the organization’s CAPA objectives and apply regulatory requirements for complaint-handling, event reporting, recall management, and postmarket surveillance.  

Roles include: Complaint-handling personnel, quality engineers participating in complaint investigations, management representatives, RA/QA managers, medical/safety personnel responsible for triage decisions concerning reportable events, internal auditors, and customer-facing personnel such as call center representatives and field personnel.

Virtual Class Days

Virtual Class Days: 5 days, daily 1:00  - 5:00 PM ET

Related Courses

• NEW! Medical Device Postmarket Surveillance (PMS) Implementation Training
• ISO 14971 Medical Device Risk Management Training

Virtual Session Details

The same great training, from the comfort of your home or office

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

This class can also be delivered as a private virtual learning exclusively for your company. 

Online Training Schedule

• This training is delivered as five consecutive half-day sessions.
• Daily sessions run from 1:00-5:00 p.m. Eastern time (ET).
• This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

Tablets and mobile devices may lack some essential functionalities and are not recommended.  

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