Laboratory Qualification & Validation

Dr. Ahmed Saad Qc Manager Dr. Mostafa Hafez Deputy QC Manager

Course Description

One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this to the drug development process and have separately expanded method validation requirements in recent years.

Who should attend ?

You must have 1 year of on-the-job experience in Quality Control or Quality Assurance.

Course Topics:

Analytical Instrument qualification Analytical Method validation ( Assay, Dissolution, Impurities& Identification) 


Dr. Ahmed Saad  Dr. Mustapha Hafez

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10 Items

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1 Year
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