Books tagged: 483 letter

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PHARMACEUTICAL 483 SAMPLER
Price: Free! Words: 4,000. Language: English. Published: March 25, 2012. Categories: Nonfiction » Business & Economics » Quality control
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. 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 Validation