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Conference Documentation: Computer Systems Validation in the Pharmaceutical Industry (2010)

SMI Publishing, Ltd
April 21, 2010
SKU: SMI2770684

Abstract Table of Contents Related Reports

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.

DAY 1
8.30 Registration & coffee
9.00 Chairman's opening remarks: Mark Stevens, Managing Director, GxPi.
9.05 OPENING KEYNOTE: HOW CAN WE APPLY 'LEAN THINKING' TO CSV?: The lean approach to achieve quality, a brief overview of how companies apply lean to get it right first time.; Translating lean philosophies and principles into the CSV area; Challenges in a regulated environment; Henrik Olsson, Clinical IS Quality & Compliance Team Leader, AstraZeneca.
9.40 THE ROLE OF QA DEPARTMENTS: What is the role of QA in CSV?; Where does CSV fit into the quality model?; What tools can be used to expedite CSV?; Minimum documentation requirements; Trev Simmons, Founder, A1 IT Compliance.
10.15 CSV IN CLINICAL R&D: GCP vs. CSV vs. common sense - where does one start and the other end?; Problems and remedies in a research laboratory which analyses clinical trial samples - practical experiences; Relationships between different involved groups - technicians, statisticians, research, informatics and quality; Willi Ramseier, Senior Systems Validation Analyst, Hoffmann-La Roche.
10.50 Morning coffee
11.20 IMPEMENTATION OF A RISK-MANAGED APPROACH TO COMPUTERISED SYSTEMS VALIDATION: Defining a computerised system; Computerised Systems Risk Assessments; How did we do it?; David Smith, PDQV Head of Validation Services, Hoffmann-La Roche.
11.55 GAMP5 - A CSV APPROACH FOR GCP?: Developing System Life Cycle SOPs for the clinical area; Validation, change management and retirement of computerised systems; Improving quality and compliance; Olaf Moelders, Portfolio Management Officer, Bayer Schering Pharma.
12.30 Networking lunch
1.45 THE SYSTEM ADMINISTRATION PROCESS - A RISK-BASED APPROACH: Brief introduction to the new ISPE GAMP Good Practice Guide "A Risk-Based Approach to the Operation of GxP Computerised Systems"; Case study: a scalable approach to system administration and change management; The role of the System Administrator in maintaining the validated state of a system; The implementation of an electronic system administration and a change management support system; Benefits and lessons learned; Rob Stephenson, Consultant, Elmstone Systems.
2.20 A RISK-BASED APPROACH TO A QUALIFIED INFRASTRUCTURE: Trends in infrastructure management and control; How to identify gaps in your infrastructure qualification; Reducing cost while staying in compliance; Marcelo Furlan, PGXQ - Global Informatics Quality, Roche Products.
2.55 Afternoon tea
3.25 BRINGING EFFICIENCIES INTO A COMPUTER SYSTEMS CHANGE CONTROL: What is change control, and what regulations govern it?; What are the consequences of 'non-managed' changes?; Which type of Quality activities are managed by computer systems?; What IT change management process should be in place?; How much testing, documentation and input from QA is appropriate to maintain the GxP state?; Adil Gatrad, Director, Corporate Quality Computer Compliance, Watson Pharmaceuticals.
4.00 VENDOR AUDITS AND RISK-BASED CSV: Minimising validation effort using a risk-based approach; Using test and requirements management tools; Vendor audits and the reuse of vendor specifications; Torben Thorhauge, Life Sciences Consulting, NNIT.
4.35 DOES RE-TESTING TESTED SYSTEMS ADD TO QUALITY?: Testing of COTS / in-house developed systems; Management of risks: criteria for test strategy; Acceptance of risks: support by management; Quality assurance through CSV; Birgit Kiene, Head of Computer Validation, Biopharmaceutical Department, Boehringer-Ingelheim.
5.10 Chairman’s closing remarks and close of day one
DAY 2
8.30 Re-registration & coffee
9.00 Chairman's opening remarks: Mark Stevens, Managing Director, GxPi.
9.05 DEVELOPMENT AND MAINTENANCE OF IT SYSTEMS ENSURING COMPLIANCE: Keeping within frameworks of quality, security and segregation of duties; Including CSV in project management; Maintaining validated status through efficient change control; Conclusions from audits; Wolfgang Reh, Head of Global IT Quality & Security, Roche Diagnostics.
9.40 AUDITING GxP CRITICAL COMPUTERISED SYSTEMS: Preparing for an audit - the perspective of the auditor and the auditee; Complying with regulators and ensuring 'inspection readiness'; Organising your human resources efficiently; Reinhard Voglmaier, IT Systems Validation Manager, GlaxoSmithKline.
10.15 cGMP LAB AUTOMATION AND VALIDATION - OPERATIONAL EXCELLENCE IMPLICATIONS: Removing non value-added tasks from process workflow; Applying a high level of customisation to the business process to match the software technology; Product vs. project approach - reduction in implementation time; John Helfrich, Vice President, GMP Automation Programs, VelQuest Corporation.
10.50 Morning coffee
11.20 SUCCESSFUL IT SYSTEMS - STREAMLINING VALIDATION AND QUALITY: SAP™/ERP, LIMS, CDS, eDMS, eCTD, TrackWise™ etc; Local and global implementations; Managing risk with real project experiences; Bob Mauger, Principal Consultant Validation and Quality, ABB.
11.55 LABORATORY SYSTEM VALIDATION - STREAMLINING THE APPROACH: Hardware and software - a holistic approach; Leveraging the vendor's qualification documents; Lab systems configuration control; Arthur Montague, Director, Tumont.
12.30 Networking lunch
1.30 DO CSV CONSULTANTS HELP OR HINDER CSV?: Benefits and risks of using consultants - the role of the consultant; Hidden costs of using consultants - getting the correct type of support; Are consultants creating work for themselves?; Mark Stevens, Managing Director, GxPi.
2.05 QUESTION TIME: A chance for delegates to pose questions, suggestions, and problems to a panel of speakers taken from both days of the conference; Reinhard Voglmaier, IT Systems Validation Manager, GlaxoSmithKline.; Marcelo Furlan, PGXQ - Global Informatics Quality, Roche Products.; Arthur Montague, Director, Tumont.; Wolfgang Reh, Head of Global IT Quality & Security, Roche Diagnostics.; Mark Stevens, Managing Director, GxPi.
2.50 Afternoon tea
3.20 A SENSIBLE APPROACH TO ELECTRONIC RECORDS AND SIGNATURES: The good, the bad and the downright ugly systems; Internet systems; Archiving data; George Cahill, CSV Consultant, Boehringer-Ingelheim and 4CSV.
3.55 MERGING COMPANIES, MERGING CSV: CSV implications for large pharmaceutical mergers; Uniting CSV practice in both companies pre-merge; Using merger as an excuse for overhauling CSV; Gillian Martindale, Director, GxP Compliance.
4.30 Chairman’s closing remarks and close of day two

Conference Documentation: Computer Systems Validation in the Pharmaceutical Industry (2010)

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