IT System and Data Security: GMP requirements and technical measures 18-19 March 2010 Barcelona, Spain Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1690,--) Book this option: ECA Members (EUR 1521,--) Book this option: EU GMP Inspectorates (EUR 845,--) Book this option: APIC Members (does not include ECA membership) (EUR 1605,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives You get to know the current European and American (GMP) requirements on IT system and data security including the new GAMP 5® and Annex 11 approach You get to know the current threat scenarios and how to master them technically and organisationally You are presented with the possibilities of implementing technical aspects of system and data security, especially the handling of patches, in a GMP-compliant way Background IT system security forms the foundation of trust in the generated and managed data. It is indispensable for maintaining the validated state of quality-relevant IT systems. The pharmaceutical regulations require the manufacturer to give proof of this security. Draft EU GMP Guide Annex 11 „Computerised Systems „ 8.2 Access to applications, folders, files and data should be controlled via the permission detailed within the manufacturing authorisation holder’s Information Security Management System (ISMS) 8.3 Suitable methods, commensurate to the criticality of data, should be in place to deter and record unauthorised entry and/or modification of data. These methods may include time limiting logging, encryption, and re-entry of unique identifier for critical data. GAMP 5 Appendix O 11 Security Management Measures should be implemented to ensure that GxP regulated computerized systems and data are adequately and securely protected against wilful or accidental loss, damage, or unauthorized change. In daily practice, diverse threat scenarios arise, which have to be mastered by the pharmaceutical user both technically and organisationally. Here, especially security patches can lead to goal conflicts between Change Control requirements and the necessity to react quickly. GAMP® is a trademark of ISPE http://www.ispe.org/gamp5