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Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).

Details

Start:
June 18, 2020, 9:30 am, 2020
End:
June 19, 2020, 2:30 pm
Cost:
$1499
Website:
https://www.complianceonline.com/fda-eu-annex15-ich-process-validation-qualification-cgmp-ppq-seminar-training-80375SEM-prdsm?channel=masslife