What You Will Learn
At the conclusion of this workshop, you will be able to:
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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.
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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.
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Analyze complaint investigations to accurately determine appropriate next steps: closure or escalation to Level III investigation to root cause, and reportability.
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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.
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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.
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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.
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Apply a risk-based approach to needed corrections and removals by practicing the risk assessment process leading to a recall decision.
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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:
5
In-Person Full-Days:
3
CEUs:
2.4