Module 1 of the GMPify 21 CFR Part 211 Certification Series covers 

Subparts A and B the organisational and personnel requirements that 

form the human foundation of GMP compliance. This module addresses the 

scope of Part 211 and which drug products it governs, the authority and 

responsibilities of the Quality Control Unit under §211.22 including 

oversight of contract manufacturers, personnel qualification and 

ongoing training requirements under §211.25, personal hygiene and 

health exclusion obligations under §211.28, and consultant 

documentation requirements under §211.34.

Particular emphasis is placed on the QCU's independent authority one 

of FDA's most consistently inspected areas and the common 483 

observation patterns linked to inadequate training records and 

unsupported QCU decisions.

Suitable for: QA managers, quality directors, HR and training 

coordinators, regulatory affairs, manufacturing supervisors, and all 

personnel working in FDA-regulated pharmaceutical manufacturing.

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

Source: 21 CFR Part 211 Subparts A & B, eCFR