Executives in Life Sciences organizations that make regulated products have a legal duty to ensure that their company implements whatever measures are necessary to comply with the complex and stringent requirements of the FDA (and other worldwide health organizations) – and they can be held personally liable for failing to conform with regulations.
Two events that keep these executives up at night are upcoming audits and the issuance of 483 observations and warning letter citations. And unfortunately...(read more)![]()
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