Integrated Risk Management with GAMP 5 â manage ... - we.CONECT
Integrated Risk Management with GAMP 5 â manage ... - we.CONECT
Integrated Risk Management with GAMP 5 â manage ... - we.CONECT
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<strong>Integrated</strong> <strong>Risk</strong> <strong>Management</strong> / July 2012<br />
References<br />
1. <strong>GAMP</strong> 5: A <strong>Risk</strong>-Based Approach to Compliant GxP Computerized Systems<br />
ISPE 2008<br />
2. <strong>GAMP</strong> Good Practice Guide: A <strong>Risk</strong>-Based Approach to Operation of GxP<br />
Computerized Systems<br />
3. GMP Manual Online<br />
Maas & Peither AG GMP-Verlag<br />
4. <strong>GAMP</strong> 5 <strong>Risk</strong>-Based Approach - Risiken global <strong>manage</strong>n<br />
Vortrag auf der Vision Pharma 2012 [Managing risks globally, paper presented<br />
at the Vision Pharma, 2012], Karlsruhe<br />
Thomas Halfmann<br />
Author<br />
Thomas Halfmann<br />
Partner of the <strong>manage</strong>ment consultancy Halfmann Goetsch Peither AG,<br />
Switzerland, Germany ISPE 2009, Singapore<br />
www.hgp.ag<br />
© 2012 HGP AG, CH-Basel, All rights reserved Page 6 of 6