What's the second fastest way to get a warning letter?
Answer: Fail to follow FDA protocols when dealing with and processing complaints.
What's first?
CAPA violations.
Now available is a new FDAnews management report , "Medical Device Complaint Management: A Guide for Compliance."
It's easy to understand the problem. You must cross every T and dot every I, creating systems that integrate data collection, complaint evaluation and risk assessment, as well as processes that determine how complaints are categorized and whether they are valid.
And further complications exist. Multinational companies, for instance, must consider how to share complaint information across divisions or product lines.
But, FDAnews has just released a new management report written especially to help device manufacturers avoid warning letters and other FDA sanctions — by spelling out in plain English the do's and don'ts of effective device complaint management.
"Medical Device Complaint Management: A Guide for Compliance" provides a complete explanation to help you comply with FDA requirements, including:
- How to evaluate each complaint to determine if a Medical Device Report (MDR) is required
- What service people should be watching for, to identify complaints when interacting with consumer
- Training the sales force to recognize and report complaints
- Key terms, definitions and forms you are responsible for when submitting MDRs
- Which staffers are qualified to make medical judgments, and who the FDA will deem appropriate
- Distinguishing between corrections and removals
- Defining key terms — "market withdrawal," "routine servicing," "stock recoveries" and others
- When a report is required for a correction or removal, and which documents must be kept on file in event of a report filing
It's certain that FDA's inspectors will examine your complaint management reporting systems on their next visit. Now is the time to start whipping your systems into shape. The report is written especially for professionals working in:
- Quality
- Manufacturing
- Engineering
- Regulatory affairs professionals
- Legal
- Compliance officers
- Consultants/service providers
- Legal
"Medical Device Complaint Management: A Guide for Compliance" is available in print or PDF format for $397.
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