Quality System Requirements, N95 NIOSH Approved Respirators is required by the FDA.  FDA enforcement of normal requirements for Face Masks and N95 Respirators has relaxed during the COVID-19 Global Pandemic. On April 2020 (revised on May 2020) the FDA issued Guidance “Enforcement Policy for Face Masks and Respirators During the Corona Virus Disease (COVID-19) Public…

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The COVID-19 Pandemic has brought the issue of hand sanitizer requirements and their regulation to the national forefront.   Because of the public health emergency, the FDA has stated that they do not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs…

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Metric Reporting

Metrics, This one word can cause many emotions, fear, trembling, excitement, or dread! I have experienced all of these emotions when it comes to metrics. That Pareto Chart ascending or descending in at a particular elevation or curve can have a profound effect upon us! The FDA has recognized the importance of Quality Management System…

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