4 5 6 7 8 9 10 11 PROPOSEDDOCUMENT12 GlobalHarmonizationTaskForce13 14 15 16 Title:Qualitymanagementsystem–MedicalDevices–Guidanceoncorrectiveac-17 tionandpreventiveactionandrelatedQMSprocesses18 19 AuthoringGroup:StudyGroup320 21 Date:22 nd
Study Group 1 of the Global Harmonization Task Force (GHTF) has prepared this guidance document. Comments or questions should be directed to either the Chairman or Secretary of GHTF Study Group 1 whose contact details may be found on the GHTF web page 1 . 2.0 Rationale, Purpose and Scope ...
Quality Management Systems - Process Validation Guidance SG3 The Global Harmonization Task Force Edition 2 - January 2004 Authoring Group: Endorsed by: Date: Taisuke Hojo, GHTF Chair The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from med...
Where other guidance documents within the series are referenced within this text, their titles are italicised for clarity. Study Group 1 of the Global Harmonization Task Force (GHTF) has prepared this guidance document. Comments or questions about it should be directed to either...
GHTF-SG3-N99-10-2004过程确认指南-英文文.doc,GHTF Study Group 3 - Quality Management Systems Process Validation Guidance – January 2004 Page PAGE 12 GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Gu
GHTF-SG3-N99-10-2004 Process Validation Guidance外文电子书籍.pdf,GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authoring Group: SG3 Endorsed by: The Global Harmonization Task Force Date: E
The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry.The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject ...
7. The Use Of Study Information10 The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of ...
内容提示: GHTF/SG4/N28R4:2008 FINAL DOCUMENT Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 1: General Requirements Title: Authoring Group: Endorsed by: Date: GHTF Study Group 4 The Global Harmonization Task Force August 27, 2008 Dr. ...
FINAL DOCUMENT Title: Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers Authoring Group: GHTF Study Group 3 Endorsed by: The Global Harmonization Task Force Date: December 11, 2008 Dr. Roland Rotter, GHTF Chair The document her...