OR WAIT null SECS
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.
December 02, 2016
Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.
Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.
Republican control of Washington promises overhaul of healthcare and medical product regulation.
December 01, 2016
November 29, 2016
The commission approved future plans, appointed members, and adopted texts during its November 2016 session.
November 28, 2016
FDA has revised its draft guidance to provide greater clarity and focus. This version would establish an initial voluntary phase to allow regulators and industry to focus, first, on a limited set of metrics.
Wockhardt Limited received a warning letter from FDA for CGMP violations.
FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations
Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor
November 24, 2016
Domestic sales will be the key driver of revenue growth.