OECD Advisory Document: Quality Assurance and GLP, DRAFT, 09/21 Anastasija Eschricht2023-03-21T12:49:52+00:00March 21st, 2023|
FDA GFI, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, DRAFT, 04/22 Anastasija Eschricht2022-12-07T10:21:35+00:00December 7th, 2022|
FDA GFI, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, DRAFT, 04/22 Beatrice Burtsov2022-11-16T10:40:03+00:00November 16th, 2022|
ICH Guideline, Analytical Procedure Development, Q14, DRAFT, 04/22 Beatrice Burtsov2022-11-08T13:14:37+00:00November 8th, 2022|
FDA GFI, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, DRAFT, 05/22 Beatrice Burtsov2022-09-07T15:32:08+00:00September 7th, 2022|
FDA GFI, Risk Management Plans to Mitigate the Potential for Drug Shortages, DRAFT, 05/22 Beatrice Burtsov2022-09-07T15:19:16+00:00September 7th, 2022|