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Published by: SMI Publishing, Ltd
Published: Feb. 15, 2006
Table of Contents
- Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Mrs Michelle Whitehead Lemasters, Technical Manager, Schering Plough.
- 9.10 RISK MANAGEMENT PRINCIPLES FOR COMPUTERISED SYSTEMS
- Developed by the PhRMA association and shared with the FDA
- John Andrews, Director, Andrews Consulting Enterprises Ltd.
- 9.50 RISK-BASED COMPUTER SYSTEMS VALIDATION
- Concepts of CSV
- Identifying and managing potential threats to keep systems free from compliance risk
- Quantifying the effect of the threat on your systems and gauging your response
- Appropriately applying technologies to ensure consistent security management of critical systems
- Ensuring the availability and dependability of critical systems
- How to make sure that your response to validation is measured, robust and remains practical, achievable and adds value
- Mr Ian Storr, Managing Consultant, PA Consulting Group.
- 10.30 Morning Coffee
- 11.00 A RISK-BASED APPROACH TO VALIDATING NETWORKS
- Reducing the validation burden
- How to justify and document these approaches
- Evaluating existing networks
- Assessing the risk posed by the network- low, medium or high?
- The reality of a risk-based approach for companies
- Mr Ramkumar Rayapureddy, Director, Automation Integration & Computer Systems Validation, Schering Plough.
- 11.40 A RISK-BASED APPROACH TO QUALIFIED INFRASTRUCTURE
- New guidelines from GAMP about Infrastructure Qualification
- How to identify gaps in your infrastructure qualification
- New GAMP good practice guidelines for infrastructure qualification
- Roadmaps and best practices to a qualified infrastructure
- A horizontal approach to qualification- the building block concept
- Reducing the cost while staying in compliance
- Ensuring a risk-based approach
- Mr Morten Urhoej Palm, Manager & Senior Consultant, NNIT A/S.
- 12.20 Networking Lunch
- 2.00 PANEL DISCUSSION
- What risk-based methodologies are being used in the industry?
- What are the various methods involved?
- Who gets involved?
- What standards need to be followed?
- How are these methodologies structured?
- Dr Siegfried Schmitt, Quality Director, GE Healthcare.
- Ms Dee Carri, Founder & Director, Torque Management.
- Mrs Michelle Whitehead Lemasters, Technical Manager, Schering Plough.
- 2.40 MAINTAINING QUALITY IN AN OUTSOURCED ENVIRONMENT
- The next step?
- Outsourcing life cycle from a QA perspective
- Benefits and risks associated with outsourcing
- Issues to be managed and points to consider
- Considerations: people, cultures, systems, processes, information, access
- Accountabilities and relationships
- Managing improvement as well as maintaining the status quo
- Mr Chris Reid, Director and Principal Consultant, Integrity Solutions.
- 3.20 KEY INFORMATION STRATEGIES FOR THE VALIDATION OF LABORATORY INFORMATION MANAGEMENT SYSTEMS (LIMS)
- Complying with FDA requirements when using a risk-based approach
- Practical strategies to develop a validation master plan, validating existing systems and prepare for inspections
- Change management strategies of existing and upgraded systems, validation of hardware and software and revalidation
- Risk considerations- the LIMS system
- Compliance of data management within the RD and QC laboratory- its relevance to CFR Part 11
- Cost-effective ways to upgrade your knowledge in validation and regulatory requirements for LIMS
- Mrs Michelle Whitehead Lemasters, Technical Manager, Schering Plough.
- 4.00 Chairperson's Closing Remarks Followed by Afternoon Tea, Close of Day One
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Dr Siegfried Schmitt, Quality Director, GE Healthcare.
- 9.10 IT COMPLIANCE, GOVERNANCE AND STRATEGY
- The growing IT compliance agenda
- Integrated compliance challenges: SOX, GXP, Privacy
- Emerging governance models
- Roles and responsibilities
- Key components of an IT compliance governance strategy
- Ms Dee Carri, Founder & Director, Torque Management.
- 9.50 AUDITING SYSTEMS
- Regulatory expectations - why they shouldn't surprise us?
- Overview of major approaches
- Regulatory standards
- Mr Earl Hulihan, Senior Vice President, Regulatory Consulting, META Solutions.
- 10.30 Morning Coffee
- 11.00 INSPECTION AND AUDITING OF COMPUTERISED SYSTEMS
- Case study- following the auditing track at Roche
- Inspections - how to cope
- Planning an audit
- Developing an audit checklist
- Evaluating SOPs governing system development, maintenance and support
- Evaluating system development deliverables in relation to SOPs and industry standards
- Preparing an audit report and addressing corrective action follow-up
- Common findings in FDA inspections and audit
- Dr Peter Bosshard, Quality Manager, ROCHE.
- 11.40 COMPUTER VALIDATION CHECKS FOR USER ACCEPTANCE OF GXP APPLICATIONS
- How much validation is enough?
- GxP regulations and compliance
- The application of GxP regulations - what is their purpose?
- Key requirements and what they mean for the company
- Status of implementation
- Consequence of non-compliance
- Responsibilities
- Mr Malcolm Knott, Managing Director, Industrial Technology Systems.
- 12.20 Networking Lunch
- 2.00 INTEGRATING INDUSTRY BEST PRACTICES
- Lean, six sigma and validation- the good practices
- Bringing these methodologies together
- Leveraging lean and six sigma for validation
- Making the business case- the cost of compliance
- Dr Siegfried Schmitt, Quality Director, GE Healthcare.
- 2.40 FDA'S CURRENT THINKING ON PART 11 AND A PRACTICAL APPROACH FOR CSV
- Computer system validation and 21 CFR Part 11
- Summary of the code of federal regulations and EU regulation
- Overview of 21 CFR Part 11
- Changes in the interpretation and enforcement of Part 11
- Impact of FDA's risk-based approach
- Implementing a practical approach for CSV
- Ms Karin Ostergren, Associate Director QA Computerised Systems, Quality Assurance, AstraZeneca.
- 3.20 VALIDATION AND LABORATORY DATA ARCHIVING CHALLENGES
- What is the FDA looking for?
- Introduction and background
- Validation and electronic data archiving
- World-wide regulations on electronic data archiving and management
- Electronic data archiving challenges
- Methods of archiving - languages for disparate systems
- The one solution - XML in archiving
- Future trends in archiving regulations
- Dr Bhanu Sharma, Global Quality, Validation and Documentation, Bayer.
- 4.00 Chairperson's Closing Remarks Followed by Afternoon Tea, Close of Conference
AbstractThis conference will provide attendees with the latest developments in Computer Systems Validation. There will be an outline of the future trends and innovations in the market. Close attention will be given to FDA standards and how these requirements effect the development of validation systems.
There will be an overview of the current 'hot' issues effecting the industry. These include outsourcing and governance and strategy- are these the next stage for businesses to consider?
An opportunity to listen to presentations from major companies discuss the technical implementation of the legislation governing the validation of computer systems. Listen as they share their knowledge of controversial issues and real problems.
SMi’s 6th Conference on ‘Computer Systems Validation’ seeks to provide a forum for leading industry experts from major companies to discuss and evaluate the latest challenges and problems facing the market. The conference will provide attendees with an excellent opportunity to network, enhance your company’s profile and keep up-to-date on the latest issues in the Computer Systems Validation market
This years speakers include:
- Dr Guy Wingate, Director, Strategy, Systems & Knowledge Management, Global Manufacturing & Supply, GlaxoSmithKline
- Dr Siegfried Schmitt, Quality Director, GE Healthcare
- Ramkumar Rayapureddy, Director, Automation Integration & Computer Systems Validation, Schering-Plough
- Karin Ostergren, Associate Director, QA Computerised Systems, Quality Assurance, AstraZeneca
- Dr Bhanu Sharma, Global Quality, Validation & Documentation, Bayer Healthcare
- Michelle Whitehead Lemasters, Technical Manager, Schering-Plough
- Dr Peter Bosshard, Quality Manager, F. Hoffmann - La Roche
- Morten Urhoej Palm, Manager & Senior Consultant, NNIT A/S
- Earl Hulihan, Senior Vice President, Regulatory Consulting, META Solutions
Get Full Details About This Report >>
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