| Course | |||||
|---|---|---|---|---|---|
 | FDA Regulations and Compliance This course provides a comprehensive examination of 21 CFR Part 11 the FDA regulation governing electronic records and electronic signatures in all FDA-regulated industries. Originally published in 1997 and last amended in March 2023, Part 11... | ||||
 | GMP Foundations 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... | ||||
 | GMP Foundations Module 2 of the GMPify Part 211 Certification Series covers Subparts C and D the physical environment requirements for GMP-compliant drug manufacturing. This module covers facility design and construction requirements under ยง211.42 including the... | ||||
 | GMP Foundations Module 3 of the GMPify Part 211 Certification Series covers Subpart E the incoming material control requirements that protect drug product quality from the point of receipt through to use in manufacture. This module addresses written procedure... | ||||
 | GMP Foundations Module 4 of the GMPify Part 211 Certification Series covers Subparts F and G the production and packaging controls that directly govern day-to-day manufacturing operations. This module addresses written procedure requirements and deviation... | ||||
 | GMP Foundations Module 5 of the GMPify Part 211 Certification Series covers Subparts H and I; the warehousing, distribution, and laboratory control requirements that govern finished product handling and quality verification. This module addresses finished... | ||||
 | GMP Foundations 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... | ||||
 | GMP Foundations 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... | ||||
 | Quality and Emerging Topics This course covers the regulatory framework governing artificial intelligence and machine learning in pharmaceutical GMP manufacturing from the FDA FRAME Initiative through to the Purolea warning letter, the ISPE GAMP AI Guide and FDA's planned... | ||||
 | FDA Regulations and Compliance Analytical method validation is documented proof, through laboratory studies, that a procedure's performance characteristics meet the requirements of its intended use, before that method is ever used to release or reject a batch. Every batch... |
