IT Pharma Validation Europe

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IT Pharma Validation Europe Articles and News:

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1 EudraLex Annex 11 - German Version Saturday, 03 September 2011
2 EMA news: Harmonised requirements for batch certification Wednesday, 31 August 2011
3 Annex 11 - “Computerised Systems” - Revision 2011 - Implementation Saturday, 11 June 2011
4 CRO Computer System Validation: FDA Requirements Tuesday, 29 March 2011
5 ISPE published the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) Friday, 11 February 2011
6 Guidance for Industry - Process Validation: General Principles and Practices Tuesday, 18 January 2011
7 EudraLex - Volume 4 (GMP): New Annex 11 (revision January 2011) Friday, 14 January 2011
8 New EudraLex Vol. 4 - Annex 11 - Computerised Systems Friday, 31 December 2010
9 PIC/S EXPLANATORY NOTES FOR SITE MASTER FILE Friday, 31 December 2010
10 New GHTF document - CAPA Wednesday, 01 December 2010
11 New Audit Services provided to industry Thursday, 12 August 2010
12 FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs Friday, 09 July 2010
13 Medical Devices QMS: ISO 13485 and FDA requirements Tuesday, 25 May 2010
14 Chinese ISPE GAMP 5 Version Saturday, 10 April 2010
15 Germany's BfArM moves to nearly paperless submissions (eCTD) Saturday, 10 April 2010

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