Having run highly successful CSV conferences in the past, in 2010 SMi are revisiting the issue of Computer Systems Validation in the Pharmaceutical Industry 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. Fancy speaking at the conference?  Do you know of anyone who may be interested in speaking?  We are always on the look-out for new speakers for our upcoming conferences.  Let us know: smiproduction@smi-online.co.uk. For sponsorship and exhibitioning opportunites, contact  sponsorshipdept@smi-online.co.uk.

Why should you attend this event?

Delegates at this conference will learn about Developing an overall quality model Different perspectives on CSV - regulators, industry, consultants, QA departments Mergers and CSV CSV in clinical research and development Risk-based approaches to CSV Maintaining a validated state and auditing CSV programmes CROs and CSV - regualtory implications Using consultants vs in-house CSV
	How you will benefit from attending this conference Hear from some of the most important and influential experts working in CSV Learn about implementing a 'bigger picture' approach to CSV and reducing the administrative burden Study how the biggest players in the industry implement CSV - and learn lessons for your sector Network with people you need to know in the CSV world

Hear keynote addresses from:

Wolfgang Reh Head of Global IT Quality & Security Roche Diagnostics	Reinhard Voglmaier IT Systems Validation Manager GlaxoSmithKline
Birgit Kiene Head of Computer Validation, Biopharmaceutical Department Boehringer-Ingelheim	Henrik Olsson Clinical IS Quality & Compliance Team Leader AstraZeneca

Our expert speaker line-up also includes:

David Smith, Principle Quality Risk Specialist, Hoffmann-La Roche	Olaf Moelders, Portfolio Magement Officer, Bayer Schering Pharma
Adil Gatrad, Director, Coproprate Quality Computer Compliance, Watson Pharmaceuticals	Willi Ramseier, Senior Systems Validation Analyst, Hoffmann-La Roche
Marcelo Furlan, PGXQ - Global Informatics Quality, Roche Products	Torben Thorhauge, Vice President, Life Sciences Consulting, NNIT
George Cahill, CSV Consultant, Boehringer-Ingelheim and 4CSV	Gillian Martindale, Director, GxP Compliance
Trev Simmons, Founder, a1 IT Compliance	Mark Stevens, Managing Director, GxPi Consulting
Rob Stephenson, Consultant, Elmstone Systems	Arthur Montague, Director, Tumont
John Helfrich, Vice President GMP Automoation Programs, VelQuest	Bob Mauger, Principal Consultant Validation and Quality, ABB

Who should attend?

Chief Executives, Vice Presidents, Heads, Directors, Scientists and Project Leaders of Systems Validation Information Technology  Quality Assurance Quality Control Data Management Auditing Compliance Regulatory Affairs Research and Development Laboratory Systems Management Software Quality Engineering Project Development Clinical Systems Scientific Affairs

Delegates at our previous CSV conferences came from across the world

Venue details

Crowne Plaza St James Hotel 45-51 Buckingham Gate London SW1E 6AF    Tel: +44 (0) 207 834 6655 Fax: +44 (0) 207 6307 www.london.crowneplaza.com

Crowne Plaza St James London is a traditional deluxe hotel right in the heart of the city, perfectly situated for all your business and leisure needs. In the heart of Westminster, it is just a stone's throw away from Buckingham Palace, The Houses of Parliament, the London Eye and Victoria Station.  

The hotel boasts three excellent restaurants. Bistro 51 with British and European cuisine, the Michelin Starred Indian restaurant Quilon serving south coastal Indian food andBank Westminster with a modern British menu.

A beautiful, award-winning, courtyard garden surrounds the Victorian buildings of the Crowne Plaza London St James - a peaceful oasis in the centre of London.

Booking: Book your accommodation at SMi discounted rates by: Calling us on +44 (0)870 9090 713 Sending a fax to +44 (0)870 9090 714 Emailing hotels@smi-online.co.uk   SMi discounted rates include Continental Breakfast & VAT £ 205.63 / Standard room / night for single occupancy £ 229.13 Executive  room / night for single occupancy