IMDRF Personalized Medical Devices – Production Verification and Validation, 04/23 Anastasija Eschricht2023-07-24T13:19:04+00:00July 24th, 2023|
ICH Guideline Continuous Manufacturing of Drug Substances and Drug Products Q13, 11/22 Anastasija Eschricht2023-02-24T09:11:24+00:00February 24th, 2023|
FDA GFI, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 03/15 2021-09-22T13:47:28+00:00January 17th, 2020|
FDA Questions and Answers on CGMP for Drugs, Production and Process Controls, 02/16 2020-07-31T09:44:49+00:00January 17th, 2020|
FDA GFI, Quality Considerations for Continuous Manufacturing, 02/19, DRAFT 2021-09-22T13:44:47+00:00November 20th, 2019|
FDA GFI, Technical Considerations for Additive Manufactured Devices, 05/16 DRAFT 2020-07-30T11:49:49+00:00November 20th, 2019|