cGMP 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 an integral and essential process 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 training will provide guidance to the process of ensuring that all the steps are followed to avoid producing an adulterated product as defined by the 21 CFR 110.80 Processes and Controls.
Upon completion of this course, you will be able to:
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This online training is designed for personnel/companies in the Pharmaceutical, Biotechnology and Medical Device Industries.
Employees and Management in the following areas will benefit greatly:
Personnel who manage these individuals would additionally benefit from this training by gaining a better understanding of the issues faced in ensuring a GMP-compliant raw material program.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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