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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
March 20, 2017
The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.
March 16, 2017
FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.
March 15, 2017
An enterprise quality management software system can minimize human error and help pharmaceutical manufacturers maintain standard operating procedures to prevent deviations from GMP resulting from not having or following written procedures.
The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.
March 13, 2017
Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.
March 10, 2017
The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.
March 09, 2017
The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.
The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.
March 07, 2017
The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
Dr. Janet Woodcock said implementation of Informatics Process Management is a priority during the latest Director’s Corner podcast.