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Innovative Ways of Looking at Computer System Validation
Tuesday, June 26, 2012
1:30 PM to 3:00 PM
Ron Fitzmartin, FDA
, Foresight Group International AG, United States
Dr. Trinks is a Partner at Foresight Group International AG with over 25 years of experience in Pharmaceutical R&D holding senior postions in R&D IT at Ciba-Geigy and Novartis and as CIO of Sentrx. He received a PhD in organic chemistry from the Swiss Federal Institute of Technology (ETH) in Zurich.
Eric Staib, Covance, Inc., United States
Keith founded and has led the IT & Life Science Strategy for Court Square since it's inception in 1995. Keith understands the intersection between IT and Quality within the Life Science industry and continues to drive FDA Compliant IT Solutions.
Much has been proselytized on computer systems validation (CSV) for years. However, as the pharmaceutical industry has changed, and is still changing, so the established dogma of CSV, with its associated mysticism and time-consuming and costly practices is still proving stubbornly resistant to modernization. This interactive panel session will discuss the key issues, address the hurdles to change, and present a set of clear recommendations.
Discuss the major computer system validation challenges for software/ system vendors
Evaluate the current computer system validation issues related to GCP, GMP, GLP
Summarize the meaning of of true risk-based computer system validation Enumerate recommended solutions for more efficient and effective computer system validation.
Audio Synchronized to PowerPoint