Applied Statistics for FDA Process Validation

Course “Applied Statistics for FDA Process Validation” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, “”…the collection and evaluation of data, from the process design stage through commercial production..” The guidance further delineates the […]

FDA advisors give a thumbs-up to GlaxoSmithKline’s shingles vaccine

GlaxoSmithKline’s shingles Shingrix vaccine received an unanimous vote of support by a Food and Drug Administration advisory committee Wednesday on safety and effectiveness to be used in adults 50 and older. A decision by the FDA to commercialize Shingrix is expected later this year. The agency usually follows the recommendations of its advisory panels. GSK […]

A Tour of the FDA 2017

A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA […]

FDA Device History File vs. EU Medical Devices Directive Technical Files

FDA Device History File vs. EU Medical Devices Directive Technical Files The FDA has built the DHF around control. This is the defining factor. It has designed GMPs around this. For the FDA, the DHF shows design output as a product of design input. It traces the device’s development history, and how design requirements were […]