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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.
Learn moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
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 90-minute accredited 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.
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:
– QA and QC Analysts
– Manufacturing Associates
– Shipping, Receiving, Warehouse
– Raw Material Receipt and Testing
– Quality Engineering Personnel
– Supplier Quality and Auditors
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.
Charity Ogunsanya
(Owner/CEO), Pharmabiodevice Consulting LLC
Charity Ogunsanya has more than 30 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control Subject Matter Expert (SME) for multiple fortune 100 companies.
She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and has a Masters degree from the Advanced Academic Master's Biotechnology Program at the Johns Hopkins University with concentration in Biotechnology/Biodefense. She is the CEO/ Owner of her consulting firm named Pharma biodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.