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Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
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Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Meetings and Training > Conferences >8th GHTF Conference - Ottawa, Canada 18-22 September 2000 > Final Agenda > GHTF Study Group 3 Report |
This brief is also available in Word and PDF format.
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Title of Session:
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GHTF Study Group 3 Update |
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Speaker:
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Kimberly A. Trautman kat@cdrh.fda.gov Tel: (301) 594-4648 |
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Topic:
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To outline the activities of GHTF SG3 since the last Plenary Session in Washington, DC. To discuss the joint work of GHTF SG3 and ISO/TC 210 WG#1 Ad Hoc Writing Group on the revisions to ISO 13485 and ISO 13488, as a result of the revisions to ISO 9001 and ISO 8402. To discuss the work to date on the Quality Planning Guidance document and to discuss the status of the approved work item on Risk Management. |
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About the Speaker:
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Kimberly A. Trautman is the FDA Expert on Medical Device
GMPs and Quality Systems and is responsible for writing the final Quality
System regulations. Ms. Trautman is also responsible for the development
and implementation of the extensive Quality System regulation roll-out
and training programs. In addition, she reviews inspection reports of
foreign and domestic medical device manufacturers to identify violations
of the Good Manufacturing Practice (GMP) requirements, and provides GMP
guidance to FDA field investigators and the medical device industry. Ms.
Trautman also In addition to her duties as Chair of Study Group 3 for the Global Harmonization Task Force, Ms. Trautman is also a representative to the US TAG to ISO/TC176 and ASQC Z-1/TG 11 Quality Assurance Committee, a US delegate to ISO/TC210 Quality Management and Corresponding General Aspect of Medical Devices committee and a member of ISO/TC 210 Working Group 1. Ms. Trautman holds a B.Sc in Molecular and Cell Biology and an M.Sc in Biomedical Engineering. |
Updated 22 July 2004
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