Course Description

GMP in a Nutshell: An Introduction to cGMP

Online On Demand

Course Offering 2107905OL2244A
Course ID 2244

In-Person Course

Who Should Attend?
This online training will benefit professionals in the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Industries.

The training will be especially beneficial to personnel and management in the following areas and positions: QA/QC, Laboratory, Testing Analysts, Manufacturing, Suppliers, Vendors, Validation, Supplier QA, Regulatory Affairs, Shipping and Receiving, Facility and Maintenance, Microbiologists, Engineers and Materials Management.

Course Description
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (cGMPs) regulation for human pharmaceuticals.

While drugs represent only one third of the Food, Drug and Cosmetic Act, drugs are impacted by some of the most stringent FDA requirements known collectively as GMPs. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs.

This 90-minute accredited training session discusses some facts that may be helpful in understanding how cGMPs per 21 CFR Part 210 and 211 establish the foundation for drug product quality and how it provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

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

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 Pharmabiodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.