We are three months out from the 2019 ISPE Annual Meeting & Expo and we have finalized the titles and session topics for the Quality Systems and Regulatory Track. As director of this education track, I can tell you that the program is looking...
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...
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...
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...
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 for Industry Q10 Pharmaceutical Quality System. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...
