1. All failures associated with product or processes.
2. All products that deviate from specifications before or after distribution.
3. All customer complaints.
4. A & B

2. The regulations on Corrective and Preventive Action (CAPA) do not require that the manufacturer to:

1. Perform an assessment to assure that the corrective action implemented was effective.
2. Analyze all the events related to the failure (customer complaints, internal failures, service reports).
3. Submit all information to management for review.

3. If there is a failure of a medical device in distribution, yhe first action after the failure is confirmed should be to:

1. Halt any further distribution of the product.
2. Write a CAPA report.
3. Contact the FDA.

4. The extent of corrective and preventive action taken by a manufacturer after a failure has been identified is:

1. Dictated by FDA depending of the degree of risk involved.
2. Dictated by management after the failure is identified.
3. Should be based on guidance written as an internal procedure and based on a risk analysis performed at the design stage of the product.

5. If a failure involves death of a patient, the manufacturer does not have to initiate an investigation if:

1. The device was not used according to the product labeling instructions.
2. The user does not provide the manufacturer with detailed information on the event.
3. Both A and B are incorrect.

6. When a failure investigation results in the need to perform a significant change in the device, it is necessary to:

1. Perform a validation or verification to assure the product still meets its intended use(s).
2. Document the change as part of the Design History File (DHF).
3. A and B.

7. CAPA reports do not have to be available for FDA review if:

1. The corrective action was a result of an internal audit.
2. The failure was captured before distribution of the product.
3. A and B are incorrect.
4. A and B are correct.

8. If a failure analysis investigation leads to a faulty raw material/component as the root cause of the failure:

1. The QSR regulations do not require that the supplier perform an investigation to determine the cause and implement corrective and preventive actions.
2. The QSR regulations only require that the supplier investigate if an MDR has triggered the failure.
3. The manufacturer is required to change suppliers.

How did you do? After you have taken the Quiz, request the answers via e-mail from accureg@regulatory.com. If you include your address, we'll send you a pocket book of the GMPs for Medical Devices or for Finished Pharmaceuticals!

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