On-demand GMP, regulatory and quality systems training for pharmaceutical professionals — sourced directly from FDA regulations and ICH guidelines.
From foundational regulations to inspection readiness — GMPify covers the full scope of pharmaceutical quality training your team needs.
21 CFR Parts 210 and 211 — the core US pharmaceutical GMP regulations, section by section.
FDA guidance documents, ICH guidelines, and global standards interpreted for practical application.
QMS, deviation management, CAPA, change control — the operational backbone of GMP compliance.
OOS investigations, stability testing, release testing and laboratory record requirements.
Process controls, component management, packaging, labeling and batch record documentation.
Real FDA 483 observation examples, warning letter patterns and audit preparation strategy.
Every course is built directly from live FDA source documents — cited to the exact CFR section, updated when regulations change.
The complete 6-module certification series covering all 11 subparts of Part 211 — from organisation and personnel through to records, reports, and returned products. The most comprehensive GMP training series available for US pharmaceutical manufacturers.
The legal foundation of all US drug GMP regulations. Covers legal status, applicability, scope, and the critical definitions that underpin every GMP record in your facility.
The internationally harmonised pharmaceutical quality system framework — adopted by FDA and regulators worldwide. Covers quality policy, process performance, and continual improvement.
Built by the team behind one of North America's most trusted live pharmaceutical training programmes — now available on-demand, 24/7.
Every course is generated directly from the eCFR and FDA guidance documents — not paraphrased from third-party summaries. Every slide cites the exact CFR section.
When FDA issues new guidance or amends a regulation, our courses are updated to reflect it. Your team always trains on current requirements — never outdated content.
Every module includes real FDA 483 observation examples showing exactly what inspectors look for. Not just what the regulation says — what it means in practice.
Every completion generates a dated, attributable certificate with a unique ID — suitable for training qualification records and FDA inspection documentation.
Full catalog access from day one. No per-course fees. Cancel anytime.