Quality in Pharmaceutical Industry: GMP & Process Validation
Quality, GMP, Validation, Qualification, Calibration, Pharma, Drug, FDA, EMA, Quality Management, Risk Assesment
4.26 (314 reviews)
1,147
students
3.5 hours
content
Apr 2025
last update
$59.99
regular price
What you will learn
Understand and define main principles of Process Validation by integrating Good Manufacturing Practices (GMP)
Define general scope of quality management in pharmaceutical industry by understanding key definitions of Quality
Understand and define main principles of Qualification, Calibration and Validation
Evaluate important points of Quality Management (QM) in pharmaceutical industry
Discuss similarities and differencies of FDA and EMA guideline about Process Validation
Prepare Process Validation Protocol by understanding validation requirements
Understand sampling plan requirements by using risk assesment, and CMA, CPP, CQA approaches
Understand risk assesment, process capability and process stability approaches
Prepare Process Validation Report by evaluating data and process capability
Evaluate important points of Quality Systems (QS) in pharmaceutical industry
Understand and define main principles of Process Validation by integrating Good Manufacturing Practices (GMP)
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5276862
udemy ID
4/17/2023
course created date
5/25/2023
course indexed date
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