US FDA GMP Awareness for Pharmaceuticals (21 CFR Parts 210 and 211)

It is for operators, storekeepers, laboratory staff, engineers, supervisors and managers in plants that make medicines for the United States, and for sites that supply the US market. It helps every employee understand what US FDA current good manufacturing practice asks of them and how their daily habits protect product quality. No prior knowledge of GMP is needed.

It is built on 21 CFR Parts 210 and 211: why cGMP matters and who must follow it, the quality unit and quality system, people, hygiene and gowning, facilities and equipment, materials, production and in-process controls, packaging and labels, the laboratory and out-of-specification results, records and data integrity, deviations and change control, complaints and recalls, and what happens in an FDA inspection.

It is a set of short video modules, each followed by practice questions, and a final exam. The course page shows the number of modules and the approximate video runtime; allow additional time for the practice questions and the exam. With 12 months of access, learners can complete it in one sitting or over several sessions.

Yes. Learners who reach the 70% pass mark in the final exam receive a Sterling Academy Certificate of Completion for US FDA GMP Awareness for Pharmaceuticals (21 CFR Parts 210 and 211). Each certificate carries a unique number and a QR code, and anyone can check it online using the certificate number and the holder's surname. It is a training certificate for the individual learner.

Yes. It is a self-paced online course made of short video modules, in English with captions. You study at your own pace during 12 months of access, and practice questions after modules help you check your understanding before the final exam. If a point is unclear, questions are answered by a Sterling consultant.

The course is US$19 per learner. Teams save 20% for 11 to 50 learners and 30% for 51 to 200 learners; 201 or more learners are priced on request. Client administrators can track their team's progress. Prices are in US dollars, excluding taxes, and Sterling confirms final pricing and enrolment.

No. The Certificate of Completion is a training certificate: it shows that one person completed the course and reached the pass mark in its final exam. Whether a site meets US FDA cGMP is decided by FDA through its own inspections. Sterling does not certify organisations.