The FDA requires medical device and drug manufacturers to train their employees. Training must occur for all types of regulated activities from internal quality management procedures/policies to CFR requirements. The agency expects companies to establish comprehensive procedures that not only detail how the staff will be trained but also complies with the QSR record keeping […]
Join 360factors CEO Ed Sattar at the ISO 9000 World Conference in Houston, Texas on March 9-10. Now on its 23rd year, the conference has become one of the most important annual gatherings in the world bringing together leaders in the field of ISO 9001, IS0 14001, ISO 3485, ISO 9000, AS9100 and QMS […]
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009. The program targets investigator sites, sponsors and contract research organizations (CROs) in either the US or the European Union (EU).
These joint GCP inspections stem from an arrangement between […]