Module 6 is the final module of the GMPify Part 211 Certification Series covers Subparts J and K, completing your full regulatory foundation in 21 CFR Part 211. This module addresses record retention periods and availability requirements under §211.180 including the annual product quality review, equipment logs and component records under §§211.182 and 211.184, master production record requirements under §211.186, batch production record content and documentation obligations under §211.188, the QCU batch record review requirement and failure investigation obligations including the requirement to extend investigations to associated batches and products under §211.192, laboratory record requirements under §211.194, distribution and complaint file requirements under §§211.196 and 211.198, and the handling, testing, and disposition of returned drug products under §211.204 and the absolute prohibition on salvaging products exposed to adverse conditions under §211.208.

Completion of all 6 Part 211 modules qualifies learners for the GMPify Part 211 Certification Series certificate.

Suitable for: QA, QC, regulatory affairs, records management, distribution and logistics, and all personnel responsible for GMP 

documentation and batch record review.

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

Source: 21 CFR Part 211 Subparts J & K, eCFR