Disk 8 of 10 (37 minutes)
You can buy the individual disks, or you can buy the complete training set for a 30% savings.
Outline
- Introduction
- Complaint handling 21 CFR § 820.198
- Definition: complaint
- Situation analysis - complaints
- Situation analysis - user error
- Complaint files & procedures
- The preamble on documenting oral complaints
- MDR reportable complaints
- Adverse event vs. MDR reportable event
- MDR and surgical intervention
- Complaints not investigated
- Preamble on initial complaint review
- Complaint investigations
- The preamble on duplicate investigations
- MDR reportable complaints
- MDR reportability of adverse events occurring outside of the U.S.
- Q: Which of the following “complaints” would not require an investigation?
- Documenting complaint investigations
- Complaint investigations
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- The preamble on complaint investigations
- Situation analysis - complaints and design changes
- Additional information for MDRs
- Complaint record accessibility
- The preamble on complaints not maintained at manufacturing site
- Foreign complaint records
- Servicing requirements 21 CFR § 820.200
- The preamble on servicing
- Servicing instructions
- The preamble on servicing to “meet specified requirements”
- Analysis of service reports
- The preamble on corrective action for service requirements
- Reporting service reports under MDR
- Situation analysis
- Documenting service reports
- The preamble on documenting service reports
- Summary
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System requirements
- Windows XP (Service Pack 3), 7, 8
- Internet Explorer 6 or later
- Note: This program will not run in Chrome, Firefox, or Safari. It will not run on a Mac.
You can buy the individual disks, or you can buy the complete training set for a 30% savings.
