Interactive Workshop C
8:30 AM - 12:00 PM
--Special Paper Notebooks Workshop--
Developing Notebook Documentation Requirements Specific to Laboratory Function
Abbie E. Gentry, Ph.D., Director of Contract Development and Analytical Technology, McNeil Consumer and Specialty Pharmaceuticals

I. QC Notebooks
- Documenting routine tests
- Important success factors
- Satisfying compliance requirements
- Minimizing analyst documentation time
- Easy review
- Documentation of investigations

II. R&D Routine Analytical Laboratory Notebooks
- Documentation of routine testing
- Satisfy Compliance requirements
- Easy review
- Consistency Format
- Quick retrieval of raw data
- The ability to cross-reference work between analysts
- Documentation of investigation strategies and results

III. R&D Product Development Laboratory Notebooks
- Documentation of ideas and experiments
- Compliance requirements
- Documenting inventions and reduction to practice
- In-depth observations of experiments
- Documentation of investigation strategies and results

IV. Special Considerations for Hard-Copy Documentation
- Notebook and data retention and storage
- Cross-referencing work between scientists
- Corrections upon review or audit
- Data interpretation
- Standardization

V. Interactive Exercise
Participants will develop documentation requirements for R&D and QC notebooks.

Participants will take home the following Bonus Information:
- Participants will receive a copy of the documentation requirements developed

12:00 - Lunch for Pre-Conference Workshop Participants

Monday, July 18, 2005
Main Conference 90-Minute Sessions

12:00 - Main Conference Registration

Interactive Session 1
1:30 PM - 3:00 PM
ELNs and Organizational Strategy
Joseph Logan, IS Strategy, Performance, and Knowledge Services, AstraZeneca Pharmaceuticals

I. IT Projects, ELNs and Organizational Strategy
- An application of a strategic and theoretical plan
- The link between the IT project's goals and intended outcomes
- Common causes for failure in IT projects
- Adopting a more intentional approach to executing strategy through IT investments

II. Techniques for Success in Selecting and Implementing ELNs
- Explicit strategic and organizational alignment
- Attention to the three organizational success factors for IT projects
- Conscious attention to learning and adaptation
- Clarity about performance
- Ongoing evaluation

III. Interactive Exercise
Participants will analyze real life situations and assess success factors and lessons learned. Attendees will receive a handout outlining the technology alignment process.

Participants will take home the following Bonus Information:
- Technology alignment brochure
- Excerpt from Logan chapter on IT strategy and alignment

Interactive Session 2
1:30 PM - 3:00 PM
Building Quality Electronic Records Programs (QERPs) Products, Systems, Technologies, and Standards
Rich Lysakowski, Ph.D., Executive Director, The Collaborative Electronic Notebook Systems Association (CENSA) and Global Electronic Records Association (GERA)

I. Planning for the Lifecycle of an Electronic Evidence Protection Program
- Securing the mandate for budgets and resources to get started
- Preserving records' authenticity, credibility, and trustworthiness - while facing continual technical change.
- Understanding the lifecycle activities of an "electronic evidence protection program"
- Understanding the Capability Maturity Model for Electronic Records

II. Implementing Quality Electronic Records Programs and E-Notebooks
- Selecting the best QERPs policies, procedures, documentation, and
- Instituting and tracking conformance with practices to meet requirements
- Selecting products, standards, vendors, and installing
- Validating, verifying, auditing proper operations of program components and ongoing training to meet continuous quality improvement needs
- Selecting and implementing E-Notebooks to meet your enterprise goals

III. Operating Quality Electronic Records Programs
- Climbing the capability maturity ladder for electronic records
- Preserving authenticity, credibility, and greatest residual value
- Maximizing value creation and reuse by integrating your QERPs with the value creation goals of the enterprise
- Reaching the pot of gold at the end of the rainbow.

Interactive Session 3
1:30 PM - 3:00 PM
Advanced ELN Qualification Techniques
Virginia L. Corbin, Manager Corporate Compliance Marketing, Waters Corporation

I. FDA Expectations
- Expectations for 21 CFR 210 and 211
- Expectations for 21 CFR Part 11
- Expectations for 21 CFR 58

II. Customer Versus Supplier Requirements
- Supplier supplied qualification tools
- Customer requirements
- Understanding qualification data

III. Risk Assessment
- Consistency across the organization
- What types of tests to run for analytical systems
- What types of test to run for applications software
- Fit for intended use the last step

IV. Assurance of Data Integrity
- Advanced Qualification Technology
- Tamper proof data and QA Check

V. Out of Specification
- Investigation, change control and risk

VI. Interactive Exercise
Participants will do a real life paper (traditional) exercise for software and leave with examples of the kind of tests to run for software and analytical systems.

Interactive Session 4
1:30 PM - 3:00 PM
Global Regulations and Computers in the Laboratory
Teri Stokes, Ph.D., Director, GXP International

I. Common Themes for Quality of Computer Systems and Electronic Data in Global Regulations
- What are the common quality and integrity issues for electronic data and computerized systems found across regulations -EU GMP Annex 11, OECD GLP, GCP/CSUCT, HIPAA, 21 CFR Part 11?
- How can QA folks and other non-IT specialists review and evaluate compliance efforts for computer systems in the laboratory?

II. Management Commitment - The Essential Ingredient in Computerized System Validation (CSV)
- How can management show due diligence for staying in control of electronic data and computerized systems?
- How does computer validation relate to and differ from method validation in the laboratory or process validation on the manufacturing floor?

III. Interactive Exercise
- How does the Common Themes Grid apply to the OECD GLP Consensus?
- How do Grid concepts apply to your work situation?

Participants will take home the following Bonus Information:
- Journal Article: Stokes, T., Ph.D., Computer Validation in the Regulated Laboratory. Analytical Validation in the Pharmaceutical Industry 1999. A Supplement to Pharmaceutical Technology. Advanstar Communications, Vol.23, No.2, Feb. 1999, pp 30-34.

3:00 PM Refreshment Break

Interactive Session 5
3:30 PM - 5:00 PM
Successful ELN Implementation Strategies
Simon Coles, MEng, Co-Founder and CTO, Amphora Research Systems

I. The Components of an ELN System
- The scientific process
- Systems involved and their relationship to one another
- The data produced

II. US Patent Requirements
- The law around patent interferences and litigation
- The process of introducing evidence in support of patent claim
- Implications for organizations
- Electronic records
- Paper and electronic records compared

III. IT Issues
- Cultural aspects of ELNs
- System development & deployment
- Example systems

Participants will take home the following Bonus Information:
- A series of concise data sheets covering the key aspects of the workshop

Interactive Session 6
3:30 PM - 5:00 PM
Bridging the Gap to Prevent Dilution of IP Rights Perspective
Maureen Gibbons, Patent Counsel, Bristol-Myers Squibb Co., and Colin G. Sanderock, Heller Ehrman White & McAuliffe LLP

I. Fundamentals of Laboratory Notebook Keeping Practice
- Understanding the basics legal requirements for laboratory notebooks
- Meeting the requirement of the federal rules of evidence with laboratory notebook records

II. Electronic ELN- Covering All the Bases
- How will your electronic records will be viewed by the patent office and courts?
- Improving the overall chances for having admissible, credible ELN records
- Interim solutions for maintaining electronic records in the absence of an "approved" ELN
- How to successfully implement a record-keeping policy

III. Interactive Exercise
How Will You Get Your ELNs into Evidence?
Attendees will be given an interference hypothetical and challenged to devise strategies for getting the record into evidence to prove conception and reduction to practice

Interactive Session 7
3:30 PM - 5:00 PM
Preparing an Electronic Laboratory Notebook System for a Regulatory Audit
Joe Cwiertniewicz, RQAP-GLP, CQA, Principal, Quality and Regulatory Compliance

I. Planning for Success
- Documentation that will be needed
- What initial tasks must be performed?
- What resources are available?
- Building on previous experience
- Working towards completeness
- Buy-in and commitment

II. Completing the Tasks
- Generating protocols and plans
- Performing validation tasks
- Reviewing and approving the results
- Collecting and assembling the documentation
- Review and approval of validation reports
- Summarizing, indexing and archiving

III. Interactive Exercise
Participants will identify the steps in the validation and documentation process, resources needed, timelines and deliverables for a validated and compliant system.

Interactive Session 8
3:30 PM - 5:00 PM
--Special Paper Notebooks Session--
Laboratory Record Review - Roles and Responsibilities
Jerry Lanese, Ph.D., President, The Lanese Group

I. Records and Record Review - The Requirement
- 21CFR211 and Q7A
- Quality system focus
- Guidance and observations

II. Types of records - Review processes, supporting systems
- Notebooks, Logbooks, Worksheets, and Forms
- Laboratory Information Management System (LIMS)

III. Roles and Responsibilities
- QA
- Laboratory personnel and management
- Senior management

5:00 PM - Close of Day One and Cocktail Reception

Tuesday, July 19, 2005
Main Conference General Sessions

7:30 AM - Continental Breakfast

8:15AM
Chairperson's Welcome and Opening Remarks

8:30AM
Keynote Presentation: Designing Comprehensive Electronic Lab Notebook Architectures so They Evolve Gracefully into Collaborative R&D Enterprise Systems
Dr. Richard Lysakowski, Chief Scientific and Technology Officer. The Collaborative Electronic Notebook Systems Association (CENSA)

Small vendors or end user organizations can readily build electronic notebook applications. However, they often have limited perspectives or little experience with requirements for scalability of users, data, or databases, distributed security and administration, data workflow between multi-vendor components that must play nicely together, and integration frameworks and toolsets to tie everything together. Yet, for large organizations, these critical thresholds will be crossed , that if not planned for, WILL make you fall, or worse yet stop your project dead in its tracks. Topics to be covered include:

- Assessing your company's needs and finding a balance-eNotebook with base functions and evolving to a "whole enterprise product" or solution
- Looking at the needs/wants of multi-disciplinary users
- Making the buy verses build decision
- Building internal life support systems versus focusing on your primary business
- Measuring functionality, extensibility and performance of a system and its architecture.
- Measuring the quality of an architecture and the amount of work to select, integrate, and apply product, product family, or product platform to specific disciplines

9:00AM
Legal Issues Associated with Transitioning from a Paper Notebook to an ELN from an In-House Perspective
Maureen Gibbons, Patent Counsel, Bristol-Myers Squibb Co.

- Determining whether current practices regarding research records (whether paper or electronic format) are legally sufficient to withstand a patent challenge or priority contest between two inventive entities
- Development of a notebook policy that addresses the concerns associated with poor record keeping, before moving to a fully electronic system
- Determining key players within an organization that should be closely involved in the selection of a particular ELN vendor
- Evaluating an ELN vendor using specific criteria

9:45AM
ELNs as Engines of Strategy
Joseph Logan, Organization Effectiveness and Performance
IS Strategy Performance and Knowledge Services, AstraZeneca

ELNs are considered by many to be the cutting edge of information technology in the laboratory. Yet, investments in ELNs are often made on the apparent strength of the technology rather than their contributions to the organization's strategy
- How are ELNs being aligned with strategy to ensure successful ROI?
- The reasons for success and failure in implementing ELNs
- Is the technology truly an advance or a rehash of familiar technology?

10:30 AM - Refreshment Break

10:45AM
Integration Techniques for ELNs and eR&D
Simon Coles, MEng, Co-Founder and CTO, Amphora Research Systems

Any successful ELN implementation requires integration between the core ELN and a variety of other software packages. Over the years a variety of techniques and tools have emerged, giving the ELN implementer a number of choices, the true impact of which can only be understood many years after the fact.
- Popular integration techniques
- Examining the positive and negative aspects
- Project management and vendor relationships in a multi-vendor project

11:30AM
Electronic Laboratory Notebooks - A Quality Assurance Perspective
Joe Cwiertniewicz, RQAP-GLP, CQA, Principal, Quality and Regulatory Compliance

This session provides insight on how a sponsor or regulatory auditor will evaluate your computerized systems. Advance planning and preparation can streamline the process and help to create positive outcomes.
- Expectations of the auditor
- Preparing for an external audit
- What records and documentation should be available?
- Who should present information about computerized systems?
- Facilitating the audit process
- Opportunities for improvement

12:15 PM - Luncheon

Interactive Workshop D
1:30 PM - 5:00 PM
Using Quality Electronic Records to Goldmine in E-Notebooks
Dr. Richard Lysakowski, Chief Scientific and Technology Officer. The Collaborative Electronic Notebook Systems Association (CENSA)

I. Getting Grounded
- Basic concepts of integrity, authenticity, reliability, custodianship, domains of care, and archival diplomatics
- Recent laws and regulations
- The critical role of records and archives management in intellectual capital utilization
- Leveraging intellectual capital to your best advantage

II. Challenges To Meet and Principles to Implement
- The main challenges to electronic records
- The key legal principles that must be observed and implemented
- The current requirements that electronic records programs must meet to ensure legal admissibility
- The most common "weak links" in records creation and recordkeeping processes
- What you can do now to maximize admissibility and weight of electronic records in all kinds of litigation

III. Technology
- What you don't know about electronic records in high-stakes litigation contests in the future (strategies for both offense and defense)
- Identifying and reducing the most common risks with electronic records
- Maintaining and enhancing the value of records and data
- The role of advanced technologies, services, and standards in supporting and thwarting litigation defense and offense
- The "weak links" in hot new electronic records product and service offerings
- Shifting buying practices to force supply side changes

IV. Using Quality Principles To Master Electronic Records
- State-of-the-art Quality Electronic Records Practices
- Using CENSA's "Legal Acceptability Guide for Electronic Records" as a Roadmap
- GERA's Quality Electronic Records Practices as the foundation
- Other resources and standards
- Mastering the Quality Electronic Records Practice (Q/ERPs) standards to mine the gold in your electronic records!

Interactive Workshop E
1:30 PM - 5:00 PM
Validation of Electronic Notebooks for FDA Compliance
Ludwig Huber, Ph.D., Compliance Program Manager, Agilent Technologies

When using e-notebooks in FDA regulated environment they need to be validated. In this workshop, we will go through all validation phases, starting from setting specifications through vendor assessment, installation, risk based testing and on-going performance control.

I. Regulatory and Industry Requirements
- Regulations and guidance from the U.S. FDA and EU
- GAMP4 and other industry guidelines
- Current inspection and enforcement practices
- The role of risk management, software complexity and level of customization

II. Developing a Validation Plan and Writing Specifications
- The importance of level of customization for validation
- Validation project plan for e-notebook software
- User requirement specifications - the most important document for e-notebook applications
- Vendor assessment - when do we need a vendor audit

III. Installation, Testing and On-Going Performance Control
- Installation testing and configuration documentation
- What and how much to test before and during operation
- Change control and revalidation after changes
- What to document for the entire validation project

IV. Interactive Exercise
Using prepared case studies from different applications small teams will develop key elements of validation documents. Together with the reference material provided during the work-shop they can be used to quickly start with validation projects after the work-shop.

Participants will take home the following Bonus Information:
- Worksheet: "Validation of E-notebooks and Application Software"
- Checklist: "Using software and computer systems in FDA regulated environments".
- Download workshop and reference material from the Internet: www.labcompliance.com/ivt

Interactive Workshop F
1:30 PM - 5:00 PM
--Special Paper Notebooks Session--
Laboratory Notebooks, Worksheets, Forms, and Logbooks
Jerry Lanese, Ph.D., President, The Lansese Group

I. Requirements for Documents and Records
- Documents
- Records
- 21CFR211
- EU
- Guidances
- Good business practice
- Quality System Focus

II. What records must be maintained
- Laboratory Control Systems that require records
- Record Format

III. Record Keeping Formats
- Where They Are Used?
- Systems controlling the records
- Interfacing with the electronic world
- Roles and responsibilities
- Notebooks and Worksheets
- Forms and Logbooks

IV. Other Laboratory Records
- System
- Format
- Roles and Responsibilities
- Sample flow
- Training, Calibration and Maintenance

5:00 PM - Close of Day Two and Cocktail Reception

Wednesday, July 20, 2005
Main Conference and General Sessions

7:30 AM - Continental Breakfast

8:00 AM
Chairperson's Opening Remarks

8:15 AM
State of the ELN Market
Michael H. Elliott, President, Atrium Research

Using the information gathered for research reports on the state of the ELN market, our speaker highlights today's current issues as well as where this Industry has developed over the last few years.
- The leaders in the creation and application of ELNs
- The secrets to successful implementations
- The current market trends
- How suppliers rate against crucial market requirements

9:00AM
Real World ELN Case Study: Documented Productivity Gains & sUsing Them to Justify the Purchase of an ELN
Richard Stember, Chief Executive Officer, EKM - Scientific Division

- The functions of an ELN that can actually improve productivity
- The diffrent features needed for research, R&D, QC and services laboratories
- How does integration with existing systems impact productivity?
- Features that are may be important outside of the laboratory

9:45 AM - Refreshment Break

10:00AM
ELN's in a cGMP Environment - the Paperless QC/QA Lab
John P. Helfrich, Director, Lab Automation Programs, VelQuest Corporation

This session will outline the key issues in "going paperless" in the laboratory to improve Intellectual Property (IP) documentation and meeting regulatory compliance needs in a cGMP environment including clinical trial phases through full manufacturing.
- FDA initiatives in manufacturing and the opportunity for electronic lab notebook processes
- How leading companies are adopting new approaches to automating R&D and compliance utilizing ELN strategies
- An innovative "method-centric" software platform, designed to electronically execute and manage laboratory protocols.

10:45AM
Knowledge Management in the Age of Electronic Lab Notebooks
Jeffrey Wiseman, VP and Technical Officer, Locus Pharmaceuticals

This presentation focuses on the ELN as a mechanism for change in R&D informatics. It addresses the question of how to define the ELN to underpin a knowledge management system, addresses key issues of system design, and finally addresses the opportunity to improve the return on investment for informatics systems, by as much as an order of magnitude.
- Delivering real return on investment
- The core elements of data capture for knowledge management
- Structured and unstructured data for knowledge management

11:30AM
Empowering the Chemist: Matching Technology and Laboratory Needs
Chris Leonard, Ph.D., Memory Pharmaceuticals

In a small pharmaceutical company, resource management is critical; including both human resources and information resources. Addressing the information system needs of medicinal chemists provides a solid foundation on which to build the rest of the drug discovery effort. Memory Pharmaceuticals deployed a discipline-specific ELN as part of a productivity platform designed to support the essential elements of the chemist's workflow. This session provides insight into our experience with the advantages of empowering the chemist by providing best-of-breed tools to advance pharmaceutical development.

12:15 PM - Close of Main Conference

12:15 PM - Lunch for Post-Conference Participants

Wednesday, July 20, 2005
Post Conference Half-Day Workshops

Interactive Workshop G
1:30 PM - 5:00 PM
Risk Assessment and Risk Management for 21 CFR Part 11 Compliance
Victoria Landers, Corporate Compliance Manager, Waters Corporation

I. Changes in the FDA interpretation of 21 CFR Part 11 compliance
- Discussion of the new FDA Draft Guidance Document for Part11 interpretation
- What is a "risk-based" approach to Part 11?
- Current Part 11 status
- Fitting Part 11 compliance in with the new FDA "GMP for the 21st Century" Initiative

II. Learn the framework for risk management
- Why do a risk assessment?
- What are the commonly industry accepted risk management approaches?
- How to apply Fault Tree Analysis (FTA), Hazard Analysis and Critical Points (HACCP), Failure Mode Effects Analysis (FMEA), and Failure Mode and Criticality Analysis (FMECA) to risk assessment for Part 11

III. Using Risk Management for 21 CFR Part 11 Compliance
- Moving forward with your Part 11 remediation plan
- Selecting the best risk management plan for your firm
- Protecting electronic intellectual property

Participants will take home the following Bonus Information:
- White Paper: "Achieving Risk Management for FDA Compliance Using ISO 14971"
- Article from May 2004 Issue of Pharmaceutical Technology, "21 CFR Part 11 and Risk Assessment: Adapting Fundamental Methodologies to a Current Rule

Interactive Workshop H
1:30 PM - 5:00 PM
Sharing and Integrating Research Records Across ELNs and the Enterprise
Jeff Spitzner, Ph.D.,Chief Science Officer, Rescentris

I. Overview: The lifecycle of ELNs in R&D organizations:
- Stage 1. Planning, gathering requirements, selecting vendors/solutions
- Stage 2. Product rollout; configuration and customization
- Stage 3. Transforming and improving processes
- Stage 4. Integrating ELNs with information systems
- Stage 5. Knowledge based decision making

II. Benefits and Business Drivers for Good Management and Sharing of Research Records
- Avoiding loss of information or expertise
- Increasing R&D productivity and preventing duplication of effort
- Avoiding decisions based on incomplete or inaccurate data
- Improving communication and collaboration
- Improving regulatory compliance and workflows
- Increasing the capture and protection of IP
- Supporting the entire product development lifecycle

III. Issues in Capturing and Sharing Research Records
- Examining research methodology, requirements for documenting and exchanging work
- Reviewing the contents of complete R&D records
- Types and sources of information associated with experiments
- Scientific software applications and
- Information systems associated with recording research

IV. Categorizing collaboration models for sharing and integrating research records
- Vertical and Horizontal collaboration
- Collaboration across time axis
- Models for collaboration
- Identify information systems involved
- Sharing information across heterogeneous ELN systems

V. Classify sharing and integration needs by stakeholder and workflow
- Scientists and Business and R&D management
- Legal/Regulatory and IT
- Identifing key junctures in R&D processes for data integration
- Planning for cross-discipline sharing of ELN systems and data

VI. Technical issues and approaches
- Using scientific data standards
- Strategies for encoding complete research records
- Products and technologies for sharing and integrating data
- Ontologies and data transformation

VII. Planning for different requirements, uses of research
- What the scientists need
- Reusable scientific data repositories by content type
- Identify legal and regulatory needs
- What business/R&D management needs

VIII. Planning to share research records across ELNs and the enterprise
- Examine and model complete R&D workflows
- Identifying the different kinds of information systems
- Reviewing models for collaboration and integration
- Multi-discipline scientific tools and databases
- Establishing goals and metrics

IX. Interactive Exercise
The goal of this interactive activity is to understand key issues and requirements for collaboration and integration of information systems and ELNs in order to begin assessing the participants' own enterprise needs.

Interactive Workshop I
1:30 PM - 5:00 PM
Computer Validation for Laboratory Systems - Supplier, IT/IS, and Lab User Roles and Responsibilities
Teri Stokes, Ph.D., Director, GXP International

I. Who Does What in Computer Validation?
- What can you expect for the software/system supplier?
- When and how does the IT/IS department fit into validation?
- What is expected of the end user department?
- Documentation each role is expected to produce
- What is management's role?

II. Addressing Lab Systems Already in Production Use?
- Documents for a retrospective HPLC validation project
- Validation Plan and Test Plan
- A Traceability Matrix and how does it help in validation
- The difference between a validation summary report and a test summary report?

III. What Constitutes Auditable Test Documentation?
- Essential elements to include in a test case/script
- What makes a testing process auditable?
- How do test script writer, test script reviewer, tester, and witness roles relate to each other?
- Standard test log practices suitable for audit and inspection

IV. How Does Test Documentation Provide Evidence of Compliance?
- How can test documents be organized for easy handling during testing and later for audits?
- Handling technical and non-technical issues arising during testing
- What goes into a test summary report?
- Is testing all there is to validation?

Participants will take home the following Bonus Information:
Journal Articles:
- Stokes, T. Ph.D., Technology Update 2000/2001 Series: Validating Computer Systems,
Part 1: A GCP Computer System is a Lifetime Responsibility. Applied Clinical Trials. Advanstar Communications, August 2000, pp 38-43.
Part 2: GCP Validation of Platform and Infrastructure Systems, Sept. 2000 pp55-66.
Part 3: GCP Software Verification, Nov. 2000 pp. 48-58.
Part 4: The QA Role in Computer Validation, Feb. 2001 pp. 64-72.
- Stokes, T., Ph.D., Computer Validation in the Regulated Laboratory. Analytical Validation in the Pharmaceutical Industry 1999. A Supplement to Pharmaceutical Technology. Advanstar Communications, Vol.23, No.2, Feb. 1999, pp 30-34.

5:00 PM - Close of Day Three

Thursday, July 21, 2005
Post-Conference 90-Minute Sessions

7:30 AM - Continental Breakfast

Interactive Session 9 8:30 AM - 10:00 AM
ELN: 21 CFR Part 11 Compliance for Electronic Records and Signatures
David Nettleton, FDA Compliance Specialist, Computer System Validation

The session will have an interactive discussion of the requirements of 21 CFR Part 11, the FDA's Electronic Records and Signature rule.

I. The Risk-Based Approach to Compliance
- What Part 11 means, not just what the regulation says
- The current industry standards for risk assessment, security, data transfer, audit trails, electronic signatures, validation, training, and supporting SOP infrastructure
- Details electronic signatures and biometric signatures
- Required characteristics of software

II. Interactive Exercise
Participants will discuss industry standards for computer system security.

Participants will take home the following Bonus Information:
- List of industry standards for SOPs
- Product features and validation documents

Interactive Session 10
8:30 AM - 10:00 AM
E Lab Notebook Implementation: The GlaxoSmithKline Experience
Colleen McMahon, GlaxoSmithKline, Inc.
Ashley Evans, SAFE Biopharma, Inc.
Terry Zagar, Northrop Grumman Information Technology Credential speaker

This workshop will examine the issues, tactics, and results of Glaxo-Smith-Kline's eLab notebook implementation, including its digital signature capability from SAFE Biopharma, Inc.

I. Secure Access for Everyone (SAFE) Introduction
- The standard and its value
- 2005 objectives

II. SAFE Enabling GSK eLab Notebook Application
- Business rationale
- Benefits case
- Tools selection
- Change management impacts
- Policy alignment, process and legal

III. Applications Implementation
- System architecture
- Credential issuance
- Specifications used
- Systems integration overview: what, where, when

IV. Project Results and Benefits to GSK
- Intellectual Property
- Project management
- Scientists
- System integration
- Vendor

Interactive Session 11
8:30 AM - 10:00 AM
Electronic Notebooks in the Semantic Era
Tara Talbott, Scientist, Pacific Northwest National Laboratory

I. Why Should Notebooks be Semantically Capable?
- Drawbacks of a standalone system
- Benefits of data reuse
- Using an ELN as part of an integrated system
- Reintegration of the research record

II. Architecting a Semantic ELN
- Explicit notebook/records semantics and use of semantic data stores
- Standard metadata/semantic-aware protocols
- Alerting and triggering of ELN processes
- Component-based security
- Description of data formats
- Metadata extraction and translation
- A shared data store

III. Interactive Exercise
This exercise will consist of demonstration of SAM Electronic Laboratory Notebook (ELN) showing data entry, automated metadata generation and data translation. Links to relevant software and articles will be provided.

Interactive Session 12
8:30 AM - 10:00 AM
Laboratory Informatics: Understanding its Application for Process Improvement
Michael H. Elliott, President, Atrium Research

I. What are the Fundamental Concepts in Laboratory Informatics?
- What informatics is and is not
- What is the difference between LIMS, ELN, SDMS and other acronyms?
- Understanding of data types and classes
- Data lifecycle management
- The important trends in informatics technology

II. The Application of Laboratory Process Management for Improvements in Efficiency
- An introduction to Laboratory Process Management (LPM)
- The categories of LPM
- Understanding and mapping your processes
- Determining how vision drives process
- Streamlining your business process before implementation
- Implementing process changes?

III. Interactive Exercise
Participants will discuss real life challenges faced by two laboratories. These case studies will provide insight as to how companies remediate process bottlenecks.

10:00 AM - Refreshment Break

Interactive Session 13
10:30 AM - 12:00 PM
Computer System Validation of ELN
David Nettleton, FDA Compliance Specialist, Computer System Validation

The session will describe how to perform computer system validation for off-the-self software.

I. Using the Risk-based Approach to Streamline Validation Documentation
- Performing CSV using the risk-based approach steps including: user requirements, installation, specifications, hazard analysis, testing, and release
- Use of validation documentation templates
- How to perform risk assessment
- The difference between vendor and end user validation

II. Interactive Exercise
Participants will discuss a 10-step approach to computer system validation.

Participants will take home the following Bonus Information:
- List of validation documents that efficiently implement the risk-based approach to computer system validation

Interactive Session 14
10:30 AM - 12:00 PM
Understanding the Needs of ELNs for Biology
Jeff Spitzner, Ph.D., Chief Science Officer, Rescentris

I. How are ELN Requirements for Biology Different from Chemistry?
- Software information systems, databases, data sources, and data types
- Experimental design and methodology compared to the rather structured domain of chemistry
- The richness and heterogeneity of biological and bioinformatics software applications and data types
- Research protocols that may be used only once, or reused often, with substantial variation
- Observation and data collection

II. Domains and Scientific Disciplines in Biology Lifesciences
- Major biology research groups in biopharma
- Common research experiment workflows and notebook requirements
- Issues in collaboration
- How protocols are constructed and used
- Step through a microarray (gene expression analysis)

III. Information Products in Lifesciences
- Data and documents generated in biology
- How are data typically collected, managed, and tracked in notebooks?
- Preparing for the more difficult data types to manage in
- The needs for ELNs that support bioinformatics
- Identifying other common content: multimedia, large data sets
- The diversity of biological annotations, QA/QC and measurements

IV. What to Integrate in Biology ELNs: Databases and Informatics Tools
- Common databases and information systems used by biologists
- How should public and third-party content sources (databases) be used with ELNs?
- Common software applications and the information generated
- Data standards, ontologies and controlled vocabularies, and their uses in ELNs
- What informatics components/functions should be integrated within biology ELNs?

V. Regulatory Issues in ELNs for Biology
- What do you sign?
- Regulations that must be addressed
- Physical (not electronic) evidence in the ELN
- Adressing ephemeral data issues
- The impact on ELNs of downstream clinical/patient data

Interactive Session 15
10:30 AM - 12:00 PM
Data Virtualization for Long-Term Preservation
Tara Talbott, Scientist, Pacific Northwest National Laboratory

I. Preservation and Integration
- The problem: data lifetimes > application lifetimes
- Solution Strategies (virtualizing computers, OS, apps, and now - data)
- Advantages of direct data virtualization

II. Description-driven data virtualization
- Data description languages
- Descriptive versus prescriptive approaches
- Description-driven data parsers and translators
- The Data Format Description Language (DFDL) standardization effort

III. Interactive Exercise
Exercise will consist of an in depth example of a BFD or DFDL translation converting legacy data files to an XML model. Using DFDL to perform round-trip binary-to-binary translation will also be discussed.

12:00 PM - Close of Conference

HOTEL INFORMATION
Doubletree Hotel Philadelphia
237 South Broad Street
Philadelphia, PA 19107-5685
Ph: 215-893-1600 or 800-222-TREE
Fax: 215-893-1664
www.philadelphia.doubletree.com
A special room rate has been prearranged for conference participants.
Call the hotel directly at the above number and mention IVT to receive the reduced room rate.

Electronic Laboratory Notebooks - July 18-21, 2005 - Philadelphia, PA
Complete this registration form, include payment in U.S. funds, and send to:
Advanstar/Institute of Validation Technology - PO Box 6004, Duluth, MN 55806-6004
888-524-9922 (U.S. only) or 1-218-740-7028 (U.S. or international) - Fax: 218-740-6308 - E-mail: Registration@ivthome.com

Choose one breakout workshop in each timeframe.
___ Pre-Conference Workshops
Monday, July 18, 2005
8:30 AM - 12:00 PM $795 USD
A __ B __ C __

___Main Conference General Sessions, Interactive Sessions, and Workshops
Monday, July 18, - Wednesday, July 20, 2005 $1895 USD
Monday Interactive Sessions
1:30 PM - 3:00 PM
1 __ 2 __ 3 __ 4 __

Monday Interactive Sessions
3:30 PM - 5:00 PM
5 __ 6 __ 7 __ 8 __

Tuesday Interactive Workshops
1:30 PM - 5:00 PM
D __ E __ F __

___Post-Conference Half-Day Workshops
Wednesday, July 20, 2005
1:30 PM - 5:00 PM $795 USD
G __ H __ I __

___Post-Conference 90-Minute Sessions
Thursday, July 21, 2005
8:30 AM - 10:00 AM $395 USD
9 __ 10 __ 11 __ 12 __

10:30 AM - 12:00 PM $395 USD
13 __ 14 __ 15 __

__ Multiple Registrations: Send three attendees and the fourth attends FREE! All attendees must register at the same time.
__ Early Bird Discount: Register early. Payments received by May 23, 2005 will be given a 10% discount.

__The Ultimate Passport $2495 USD (SAVE OVER $1800!)
Attend the entire event at this best value price. The Passport Package Includes:

• One Pre-Conference Workshop
• Main Conference Monday through Wednesday
• One Post-Conference Half-Day Workshop
• Two Post-Conference Sessions
• Networking Cocktail Receptions
  Passport registrants must check the boxes of the workshops and sessions they wish to attend!

Method of Payment: Please note that payment is required in advance of the conference. Please make checks (in U.S. funds drawn on a U.S. bank) payable to IVT/Advanstar Communications. Confirmation of your registration will be sent. Full payment must accompany registration form. Registrations received without payment will not be processed.

Cancellations/Substitutions: Your registration form may be transferred to a member of your organization at any time. Requests for cancellations (by mail or fax) must be received by June 30, 2005 in order to receive credit for attending another IVT event. Please be aware that cancellations will not be accepted after that date. All cancellations are subject to a $325.00 processing fee. IVT reserves the right to cancel an event. IVT is not responsible for any airfare, hotel, or other costs incurred by registrants. Speakers subject to change without notice. Federal Tax ID # 592757389

You MUST mark the sessions and workshops you will be attending.
Fax, E-mail, Mail, or Call Us Today. Payment is required at time of registration.
Registration Form: Print Clearly or Attach Business Card.

Name
Title:
Organization:
Mailing Address:
City:
State:__________ Zip/Postal Code:
Country:
Telephone: ( )
Fax: ( )
E-mail:
Pmt. method: __ VISA __ MC __AMEX __Check
Credit Card #:
Exp. Date:
Cardholder's Name:
Signature:

COST TOTALS
Monday, July 18, 2005
Pre-Conference Workshops A-C $795 USD $_______________

Monday-Wednesday, July 18-20, 2005
Main Conference including
Sessions 1 - 8 and Workshops D-F $1895 USD$_______________

Wednesday, July 20, 2005
Post-Conference Half-Day
Sessions G - I $795 USD $_______________

Thursday, July 21, 2005
Post-Conference
Sessions 9 - 15 ________ x $395 USD $_______________
OR

The Ultimate Passport $2495 USD $_______________
SUB TOTAL $_______________
*Early Bird Discount -10% $_______________
TOTAL Enclosed $___________

_#877205

Thank you for your interest in the Institute of Validation Technology and we look forward to serving your informational needs in the future.

Institute of Validation Technology
P.O. Box 6004, Duluth, MN 55806
888-524-9922 (US only)
218-740-7028 (products and journals)
1-218-740-7028 (conference)
Fax: 218-740-6308
Advanstar Communications