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