Course Dates Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Details 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 Virtual Half-Days In-Person Full-Days CEUs 2.4
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