The FDA mandates on Good Manufacturing Practices (GMP) are in place to ensure the safe production of therapeutic products. With broad and often ambiguous requirements, GMP regulations have been a source of confusion for pharmaceutical, medical device and biotechnology personnel for years. Since the regulations actually require training as part of compliance, getting straight, simple answers on compliance mandates is critical.
The Life Science Training Institute (LSTI) has the curriculum you need to keep your firm cGMP compliant and advance your career. We offer a wide spectrum of training covering the “need-to-know” pieces of GMP regulations found in 21 CFR Parts 21 210, 211, 212, 225 and 820. Subjects include: surviving FDA inspections; CMC preparation and submissions; GAMP requirements; FMEA, CAPA, Root Cause Analysis and other Risk Management topics; plus a wide range of practical instruction on process validation concerns.
Browse our list of manufacturing-related courses below, or find out how we can customize any course and give your firm bulk access.