How To Operationalize a Quality Agreement for FDA Success
June 24, 2024
The business term “Operationalize a Quality Agreement” stems from my dual background as
The business term “Operationalize a Quality Agreement” stems from my dual background as
There are no FDA regulations governing writing quality or clarity. FDA Investigators will never
Preventing batch failures and protecting your business is crucial to success within the
As a plant-floor engineer, I’ve witnessed the inner workings of pharmaceuticals, medical devices,
In the realm of regulatory compliance, one acronym consistently looms large: CAPA or
The CDMO and CMO relationships and the whole kind of business dynamic is
In 2020, COVID-19 — and more recently its Delta variant — wreaked havoc
I worked for a Chief Quality Officer a number of years ago who
The following FDA live review inspection information was included in our July email
Opportunities and Risks for Dietary Supplement Companies for 2016 and Beyond 2015 is
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