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