FDA Regulatory Compliance for Medical Devices

Training and the FDA – What do they want?

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 […]

FDA vs. EU Inspections: Similarities and Differences

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 […]

Training and the FDA – What do They Require?

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 detail how staff members will be trained, but also complies with the QSR record keeping requirements.The […]