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Processing of cGMP Controlled Raw Materials

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Overview / Abstract:

cGMP Controlled Raw Materials are the most critical ingredient of any product manufacturing step hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Raw material control is a very critical part that ensures drug product quality, purity and potency. Drug product manufacturers must have a defined procedure that clearly shows how raw materials are received, stored, labeled, quarantined, tested, qualified, tracked, used, and discarded at the end of expiry.

This 1-day intensive training will provide guidance on the process steps associated with the handling and processing of cGMP Controlled Raw Materials in order to avoid producing an adulterated product per 21 CFR 110.80 Processes and Controls. This course consists of technical content, case studies, practical discussions and an exciting learning environment.


Mar 01, 2018




Live / Seminar



Credits / Hours

.6 CEUs



Presenters / Authors / Faculty

Charity Ogunsanya; (Owner/CEO), Pharmabiodevice Consulting LLC

Keywords / Search Terms

CfPA Processing, cGMP Controlled Raw Materials, 21 CFR 110.80 Processes and Controls, FDA, 21 CFR Seminar CE CME

LIVE Activity Location Details


New Brunswick
United States of America

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