Description
Having run highly successful CSV conferences in the past, in 2010 SMi are revisiting the issue of Computer Systems Validation in the Pharmaceutical Industry 2010 to look at whether the pharmaceutical industry could change its attitude towards CSV, so that it is done sensible, effectively and practically.
Taking place in London, UK, this conference will focus on a wide range of issues withing the CSV arena, including the regulatory aspects to CSV - whether the current guidelines need expanding, reinterpreting or rewriting - CSV in an R&D context, the need for a risk-based approach to CSV, the respective benefits of doing CSV in-house or contracting it out, and developing a `bigger picture` approach to CSV.
Questions examined during the conference will include: what is the role of QA departments? How much CSV is enough? Does CSV hamper clinical R&D? Should all CSV be risk-based in analysis? Should the industry use a consortium approach to vendor-CSV audit? Are consultants too widely used - would CSV be done better in-house? What are the CSV implications for mergers? How to develop a quality model?
Attend this event to discover how computer systems validation does not have to be difficult, time-consuming and costly, and to learn how to plan for better implementation of a CSV programme.
