Pharmaceutical 483 Letter Sampler (483 Summaries)
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Book Details
Author(s)
Dave Cortes
Publisher
483 Summaries
ISBN / ASIN
B007ONF5KG
ISBN-13
978B007ONF5K0
Marketplace
France 🇫🇷
Description
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 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.
His experience includes working on Fortune 1,000 companies like Johnson and Johnson, Pall Healthcare and Cardinal Health.
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 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.
His experience includes working on Fortune 1,000 companies like Johnson and Johnson, Pall Healthcare and Cardinal Health.
