If Today an FDA auditor arrives unannounced to your Pharmaceutical Plant, there is a 54.1% chance that you will be receiving a dreaded 483 with a list of observations. As a professional you need to know, for yourself, what the FDA is focusing when assessing Pharmaceutical operations. You will find here: 5 FDA Observations: 1.Observation for Training. 2.Observation for Facilities and Equipment. 3.Observation for Quality systems 4.Observation for Production Systems. 5.Observation for Cleaning Validations
“It appears as if in America there are expendable people and in Vermont, they are the mentally ill”. This is an incredible and true story. Beginning at age thirteen, Karen Wetmore was subjected to horrific treatment at Vermont State Hospital and related facilities. Through years of investigative journalism and numerous Freedom of Information Act…
About the Author Dave Cortés is CEO and Founder of 483summaries.com. Born on New York and raised in Puerto Rico, Dave Cortes is a professional engineer, certified Lean Black Belt and Project Management Professional. He has worked on Pharmaceutical and Medical Device industry for the past 16 years.
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