Course Description

Effective Handling of cGMP Raw Materials

Online On Demand

Course Offering 1707906O2764A
Course ID 2764

In-Person Course

Who Should Attend?
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

Course Description
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 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 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.

Course Director
Charity Ogunsanya, (Owner/CEO), Pharmabiodevice Consulting LLC

Charity Ogunsanya has more than 28 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 Pharmabiodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.