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Pharmaceutical 483 Letter Sampler (483 Summaries)

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Pharmaceutical 483 Letter Sampler (483 Summaries)

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 From 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

About the Author
Dave CortÃ©s 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.
His experience includes working on Fortune 1,000 companies like Johnson and Johnson, Pall Healthcare and Cardinal Health.

Country	USA
Author	Dave Cortes
Binding	Kindle Edition
Format	Kindle eBook
Label	483 Summaries
Manufacturer	483 Summaries
NumberOfPages	23
PublicationDate	2012-03-25
Publisher	483 Summaries
ReleaseDate	2012-03-25
Studio	483 Summaries

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