This course provides a comprehensive introduction to 21 CFR Part 210 

the legal foundation of all current Good Manufacturing Practice (cGMP) 

regulations in the United States. Designed for pharmaceutical 

professionals at all levels, this module covers the three core sections 

of Part 210: the legal status and enforcement authority of cGMP 

regulations, the applicability and scope of the regulation including 

key exemptions, and the critical definitions that underpin every GMP 

record and procedure in your facility.

Learners will understand why non-compliance renders a drug product 

adulterated under the FD&C Act, how Part 210 interacts with Parts 211, 

600–680, and 1271, and what FDA inspectors look for when auditing 

against this foundational regulation. Real-world 483 observation 

examples are included throughout.

Suitable for: QA professionals, manufacturing personnel, regulatory 

affairs, new hires, and anyone requiring a foundational understanding 

of US pharmaceutical GMP regulations.

Approx. 30 minutes | 5 assessment questions | Certificate on completion

Source: 21 CFR Part 210, eCFR