IVT’s 10th Annual Computer and Software Validation (CSV) case-study driven event showcases the validation process of computer systems and software. CSV has remained a FDA hot button over the last decade for the drug and device industry. This event highlights CSV processes from R&D to manufacturing and facilitates the sharing of knowledge on common interest across the GXP environment.
FDA Keynote Address:
"What if You Had to Conduct a review of Computer Software Validation?"
John F. Murray Jr, CDRH's Software Compliance Expert, U.S. Food
and Drug Administration
Best Practices for Today’s Most Challenging CSV Protocols
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Understand and implement the new EU Annex 11 -- The European equivalent to
FDA's Part 11
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Do more
with less resources -- Lean project management
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Define user requirements
critical to CSV
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Bring existing systems into
compliance
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Conduct a CSV GAP analysis
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Qualify network
infrastructures
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Ensure integrity of
electronic data
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Implement new guidelines
for lab data systems
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Develop a global CSV
program
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Manage software,
development, testing and validation
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Prepare for FDA CSV
inspections
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Use GAMP as a framework for
risk-based validation
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Ensure compliant system
upgrades
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Implement an FDA and ICH
risk-based approach to CSV
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Manage IT security in
validated environments
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Learn protocols for CSV
documentation, audit trails, SAP and PLC systems, outsourcing and vendor
audits
Just a few of our Previous Attendees:
Abbott Labs * Abraxis BioScience * ACADIA PHARMACEUTICALS INC * Alcon Research * Alexion Pharmaceuticals * AMGEN * Apotex Fermentation Inc. * APP PHARMACEUTICALS * ASTRA ZENECA * B E & K BIO PHARM * Baxter * BioMarin Pharmaceutical * CIM QUEST INC * DENDREON * DSM PHARMACEUTICALS INC * Eli Lilly and Company * Endo Pharmaceuticals * GENZYME CORP * GLAXO SMITH KLINE * Greer Laboratories * Inspire Pharmaceuticals * INVITROGEN * Johnson & Johnson Health Care Systems * Medtronic * Merck & Co, Inc * Mutual Pharmaceuticals Corp. * NOVATEK INTERNATIONAL * PFIZER INC * QTI * Roche Diagnostics * Schering-Plough * TARO PHARMACEUTICAL * Teva Pharmaceuticals USA * UDL LABORATORY INC * VERTEX PHARMACEUTICALS * Vertex Pharmaceuticals Incorporated * Wyeth
For more information or to register, please contact the Institute of Validation Technology toll free by phone at 1.888.736.8547 or via e-mail at ivtreg@ivthome.com.
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