Question

A Corrective Action Plan (CAP) for all non-conformances must be submitted to DNV GL Healthcare USA, Inc. within__________ calendar days from date of the Final report

Answer 1

The submitted question pertains to the required timeframe for submitting a Corrective Action Plan to DNV GL Healthcare USA, Inc. and, while the specific days are not stated, relates to broader regulatory compliance in the healthcare sector, including the reporting of adverse drug events to the FDA.

Step-by-step explanation:

The question relates to the healthcare industry, specifically to a compliance-related scenario involving DNV GL Healthcare USA, Inc. Corrective Action Plans (CAPs) are formal documents detailing steps to address non-conformances or areas of non-compliance. The time frame required for submission of CAPs can be a critical component of maintaining compliance with regulatory standards. While the question does not specify the exact number of calendar days within which a CAP must be submitted, it is important to note that post-regulatory approval processes, such as those monitored by the FDA, require diligent surveillance of adverse drug events. Sponsors are required to review and report any patient adverse drug experiences in accordance with FDA regulations, featuring strict reporting deadlines such as within 15 calendar days for unexpected serious and fatal adverse drug events and on a quarterly basis for other events, as per the information from LibreTexts™.