FDA Quality

White Paper - Noncompliance to FDA Quality Standards: What's the Risk to Executives?

A new white paper, Noncompliance to FDA Quality Standards: What's the Risk to Executives, by Michael Heyl, Attorney at Law, discusses major risks to upper management in highly regulated environments (e.g. pharmaceutical, medical device, laboratory, etc.) when compliance with the FDA is not achieved. The white paper also discusses safeguards that can be taken to avoid fatal violations and calamitous fines.

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FDA Quality has Weighty Responsibility

While heavily regulated companies rely on many employees to achieve FDA quality and compliance it is upper management that is primarily responsible for quality and compliance breaches. To avoid the dreaded FDA 483 statement - Management has not ensured that the quality system requirements are effectively established and maintained. To avoid these types of statements and/or million dollar fines, upper management needs to establish the following quality and compliance safeguards:

1. Regular Communication with a Quality Management Representative
2. Quality Management Review Improvement
3. A Quality Policy that Supports Actual FDA Quality Efforts
4. Technology Enablers that Track and Enforce Quality Standards

Are You Paying a Heavy Price for FDA Quality?

The U.S. Supreme Court has continually upheld the right of the FDA to prescribe broad inspectional authority in life science environments and provides upper management representatives with the motivation that will ensure their interests are protected. Learn more by downloading Noncompliance to FDA Quality Standards: What's the Risk to Executives?