Pharmaceutical Quality System (PQS)

Training
Review the purpose, elements, and implementation of quality management systems, and risk management strategies. Highlights include a review of change control, CAPA, and internal assessment programs. At the conclusion of...
Training
Gain an understanding of the purpose, elements, and implementation of contamination control programs, as well as the impact of emerging process, development and control strategies on traditional validation practices. At...
Training
This highly-interactive, online course reviews the quality system and its importance within the USFDA Systems Inspection Approach , as well as the roles and responsibility of the quality control unit. Quality system...
Training
Metrics programs should be a core part of a company's Pharmaceutical Quality System. This online course is designed for every person who is involved in a metrics program, including operators and quality control personnel...
Guidance Docs
Authors: David Dolgin (PSC Biotech), David Hughes (Sandoz), Matthew McMenamin (GSK), Parab Parkash (BMS), Domenico Schiavone (Fresenius-Kabi), Chris...
Guidance Docs
Guidance for Industry Q10 Pharmaceutical Quality System. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...