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How to kick-start your CAPA process.

作者信息

Peterson Ken

机构信息

PathWise Inc., USA.

出版信息

Biomed Instrum Technol. 2005 Jan-Feb;39(1):55-9. doi: 10.2345/0899-8205(2005)39[55:HTKYCP]2.0.CO;2.

DOI:10.2345/0899-8205(2005)39[55:HTKYCP]2.0.CO;2

PMID:15742850

Abstract

摘要

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How to kick-start your CAPA process.

Biomed Instrum Technol. 2005 Jan-Feb;39(1):55-9. doi: 10.2345/0899-8205(2005)39[55:HTKYCP]2.0.CO;2.

Integrating risk management into the CAPA process.

Biomed Instrum Technol. 2008 Nov-Dec;42(6):466-8. doi: 10.2345/0899-8205-42.6.466.

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IEEE Eng Med Biol Mag. 2004 Jul-Aug;23(4):83-5. doi: 10.1109/memb.2004.1337958.

Risk management.

IEEE Eng Med Biol Mag. 2003 Jul-Aug;22(4):166-70, 172. doi: 10.1109/memb.2003.1237528.

Validation.

Med Device Technol. 2001 Dec;12(10):38, 40.

Effective risk management programmes.

Med Device Technol. 2004 May;15(4):28-30.

FDA pilot programme in support of global harmonisation.

Med Device Technol. 2003 Nov;14(9):32-4.

Design controls.

IEEE Eng Med Biol Mag. 2003 Mar-Apr;22(2):112-4. doi: 10.1109/memb.2003.1195709.

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IEEE Eng Med Biol Mag. 2004 Mar-Apr;23(2):98-9. doi: 10.1109/memb.2004.1310998.

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How to kick-start your CAPA process.

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