Course Description

Processing of cGMP Controlled Raw Materials: Extended Online Course

Online On Demand

Course Offering 180419OP2778A
Course ID 2778

In-Person Course

Who Should Attend?
This training will benefit those involved in manufacturing, using, testing and Validating pharmaceutical gas systems in various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially personnel and management in:
  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Validation
  • Supplier Quality Assurance
  • Regulatory Affairs
  • Shipping and Receiving
  • Facility and Maintenance
  • Engineering
  • Materials Management

Professionals working as Laboratory Managers, Testing Analysts and Technicians, Suppliers and Vendors of Pharmaceutical Gas Systems and Microbiologists will find the training very worthwhile.

Course Description
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 4.5 hour 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.

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

Charity Ogunsanya has more than 26 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.