Invitation to the IVT ELN and Collaborative eRDM Informatics Conference in Dublin, October 18-20th, 2005

Rich Lysakowski rich at censa.org
Fri Sep 16 15:00:01 EST 2005



Dear Colleagues,

We invite you to the best global Electronic Notebooks and Collaborative
E-RDM Conference of 2005.

The Institute of Validation Technology and Advanstar have teamed up with
CENSA to transform the nature of conferences back to their core concerns.
This new format conference will re-emphasize electronic records lifecycle
and validation as the foundations of any good Collaborative E-RD&M
enterprise that uses eNotebooks(TM). This conference will "get back to
basics" for successful ELN and CeRDM implementations in industry.

See http://www.ivthome.com

Richard Lysakowski, Ph.D.
Chief Science and Technology Director & Consultant
Collaborative Electronic Notebook Systems Association
Global Electronic Records Association
19 Bowen Avenue, Suite 100
Medford, Massachusetts 01801 USA
781-395-3004 phone

(See attached file: ELN_Dublin.pdf)

Electronic Laboratory Notebooks
October 18-21, 2005 - Dublin, Ireland

Tuesday,October 18, 2005
Pre-Conference Half-Day Workshops
7:30 AM - Conference Registration and Continental Breakfast


Interactive Workshop A 8:30 AM - 12:00 PM
ELN Implementation - Strategies for Success
Simon Coles, CEO, Amphora Research Systems
John Trigg, Chairman AAMG, Royal Society of Chemistry, London.


I. Identifying an Implementation Methodology
- Choosing the right implementation approach
- Getting the balance right
- Managing uncertainties


II. Getting the Business Case Right
- Scope and scale
- ROI
- Strategic issues
- Legal matters


III. Understanding User Needs
- The "toaster" problem
- Likes, wants and needs


IV. Choosing the Winning Technologies
- Data formats and standards
- Diversity and flexibility
- Devices


V. Addressing Cultural and Behavioral Issues
- Hype cycles
- Organizational, business and user culture
- Crossing the chasm
- Change management


VI. Avoiding Project Management Pitfalls
- What can go wrong?
- Project strategies
- Planning for success


Interactive Workshop B 8:30 AM - 12:00 PM
Regulatory Submissions: An Overview of the Electronic Common Technical
Document (eCTD) and Related Compliance Issues
Victoria Lander, Corporate Compliance Manager, Waters Corporation


I. An Overview of eCTD
- The history and timeline of the eCTD
- eCTD Definitions and Scope
- Using an ELN as part of the e-submissions process
- The eCTD guidance document; how to interpret it
- FDA expectations for eCTD implementation


II. Compliance Issues
- How to apply the structure and framework of the eCTD in order to better
organize your electronic records
- How 21 CFR Part 11 fits in with the eCTD
- Technical requirements for electronic records management
- Validation issues for electronic records

III. Practical Implementation of the eCTD
- Submission and Review tools
- Ten eCTD issues for success
- How using an ELN will aid in managing e-submissions
Participants will take home the following Bonus Information:
- Copies of various FDA and EMEA regulations and regulatory guidance plus
reference materials on the eCTD and electronic records management.


Interactive Workshop C 8:30 AM - 12:00 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?
- Addressing Lab Systems Already in Production Use?


II. Documents for a Retrospective HPLC Validation Project
- Validation Plan and Test Plan
- A Traceability Matrix and how it helps 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


IV. 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


V. 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.


12:00 - Lunch for Pre-Conference Workshop Participants


Tuesday, October 18, 2005
Main Conference 90-Minute Sessions


12:00 - Main Conference Registration


Interactive Session 1 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
- Instituting and tracking conformance with practices to meet requirements
- Selecting products, standards, vendors, and installing
- Validating, verifying and auditing proper operations of program
components and ongoing training to meet continuous quality improvement
needs
- Selecting and implementing E-Notebooks to meet 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 2 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
- Types of tests to run for analytical systems
- Types of tests to run for applications software


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 3 1:30 PM - 3:00 PM
Managing Paper Notebook Systems - Sometimes Low Tech is Better
Charlie Sodano, Ph.D., Information Services, Berlex Biosciences


I. Legacy Paper Systems
- Organized or chaotic
- Table of Contents - are a key to retrieval
- Setting up indexing processes
- Microfilming for disaster recovery


II. Starting from Scratch
- Loose sheets or bound?
- Policies and procedures
- Scanners are as key ingredients to capture and preserve data
- Designing an indexing system


III. Interactive Exercise
Participants will help to analyze various scenarios and list the pros and
cons of ELNs versus paper notebooks.


Interactive Session 4 1:30 PM - 3:00 PM
ELN Strategy from Vendor Evaluation to Full Deployment
Dilip Modi, Sr. Staff Scientist, Project Leader eNotebook, Incyte
Corporation


I. ELN Project Requirements
- ELN objective
- Determining the needs of Chemists, IT, and Legal
- Determining vendor criteria
- Hybrid or fully electronic


II. Pilot Stage
- Product evaluation to meet internal needs
- Integration with existing software and hardware
- Major issues and hurdles encountered
- Debugging


III. Full Deployment
- Training requirements
- Important lessons learned
- Benefits realized


3:00 PM Refreshment Break


Interactive Session 5
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 6
3:30 PM - 5:00 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
- Working with global teams
- Real-world examples from recent ELN projects


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 7
3:30 PM - 5:00 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 and 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
Participants will learn how the Common Themes Grid applies to the OECD GLP
Consensus and how 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.


Interactive Session 8 3:30 PM - 5:00 PM
Key Success Factors For High Productivity Gains
Dilip Modi, Sr. Staff Scientist, Project Leader eNotebook, Incyte
Corporation


I. Determining the Productivity Gains
- Key survey questions
- Data evaluation
- Major issues and benefits comments by end-users
- Productivity results
- Hybrid or fully electronic and possible productivity gains


II. Second Year ELN Project Review
- Major hurdles and survey results
- Continues evolvement of software
- Key success factors for high productivity gains
- Move towards fully electronic


5:00 PM - Close of Day One


Wednesday, October 19, 2005
Main Conference General Sessions


7:30 AM - Continental Breakfast


8:15 AM - Chairperson's Welcome and Opening Remarks


8:20 AM
Keynote Presentation: Designing Comprehensive Electronic Lab Notebook
Architectures so They Evolve Gracefully into Collaborative R&D Enterprise
Systems
Rich Lysakowski, Ph.D., Executive Director, The Collaborative Electronic
Notebook Systems Association (CENSA) and Global Electronic Records
Association (GERA)
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, critical thresholds will be crossed , that if not planned
for, WILL make you FAIL, 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


9:00 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


9:45 AM
Electronic Laboratory Notebooks: Their Application in a High Volume QC
Laboratory
Dennis McDaid, QC Manager, Forest Laboratories, Ireland
The pharmaceutical industry is rapidly changing from a manual-orientated
process based on paper systems to an automated-orientated process utilizing
electronic systems. This change is taking part in all aspects of the
manufacturing process including the Quality Control laboratory environment.
Within the QC environment the introduction of an electronic or paper-less
system can have significant advantages in terms of increased efficiency and
increased compliance. However, there is a cost in terms of both money spent
and personnel time from initial feasibility/conception planning, through
test environments, hardware and software installation, validation,
training, transition from one system to another and roll-out to include all
products. Initial Project Justification to Upper Management for the system
will be discussed as well as thinking on the future application of these
systems within the high volume QC environment that makes up Forest
Laboratories Ireland.


10:30 AM - Refreshment Break


10:45 AM
ELNs 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


11:30 AM
ELNs as Engines of Knowledge for Innovation
Barry Hardy, Ph.D, CKM, Douglas Connect
InnovationWell Community of Practice Manager; Director, KM Institute,
Switzerland
Innovation, as driven by the creation of new knowledge in research and
development, and its accelerated deployment into products and services on
the market, should be a key strategic goal of your organization's move to
ELN systems. The evolving field of knowledge management provides both
important strategic components and a diverse, growing toolkit of tactical
measures, methodologies and technologies that can be integrated into the
transition to or continuous improvement of your ELN systems, so as to gain
sustainable competitive advantage. This seminar will provide a knowledge
management perspective of ELNs in the following areas:
- Knowledge management as a strategy for R&D and innovation processes
- Knowledge transfer and flow within and without R&D
- Product life cycle management and ELNs
- Personal knowledge management and productivity of the scientific
researcher
- Role of collaborative R&D and communities of practice in life science
research
- Conducting a knowledge audit of your R&D organization and integrating
findings into your ELN implementation
- Impact of knowledge management approaches on the valuation of your
organization


12:15 PM - Luncheon


Wednesday, October 19, 2005
Half-Day Workshops


Interactive Workshop D 1:30 PM - 5:00 PM
Using Quality Electronic Records to Goldmine in E-Notebooks
Rich Lysakowski, Ph.D., Executive Director, The Collaborative Electronic
Notebook Systems Association (CENSA) and Global Electronic Records
Association (GERA)


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
Computer System Audits in a Pharmaceutical Laboratory Environment
Hans Martens, Computer System Auditor, Eli Lilly and Company


I. FDA and International Requirements
- Learn which rules and regulations apply
- Learn about common industry standards
- Get an update about the changed draft FDA Guidance for Industry
(Computerized Systems Used in Clinical Trials) and how these changes might
impact you
- Gain insight in some of the FDA observations


II. Performing a Laboratory Audit
- Set the scope of the laboratory computer system audit
- Understand the required SOP content
- Learn about the equipment documentation
- Discussion of hardware and software that are in scope


III. Learn about Auditing and Assessing the Following
- Computer system validation
- Change control
- Business continuity planning
- Disaster Recovery planning
- Backup and restoration
- Physical and logical security
- Electronic Records / Electronic Signatures (ER/ES), such as audit trail,
data transfer, record integrity, electronic signature and gap analysis


IV. Interactive Exercise
Using a variety of examples from the laboratory, attendees will discuss and
learn the measures that need to be taken to meet the industry standards and
to comply with the international rules and regulations.


Interactive Workshop F 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


III. Issues in Capturing and Sharing Research Records
- Examining research methodology and requirements for documenting and
exchanging work
- Reviewing the contents of complete R&D records


IV. Categorizing Collaboration Models for Sharing and Integrating Research
Records
- Vertical and horizontal collaboration
- Collaboration across time axis
- Models for collaboration


V. Classifying 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 and Uses of Research
- What the scientists need
- Reusable scientific data repositories by content type
- Identifying legal and regulatory needs
- What business/R&D management needs


VIII. Planning to Share Research Records Across ELNs and the Enterprise
- Examining and modeling complete R&D workflows
- Identifying the different kinds of information systems


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.


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


Thursday, October 20, 2005
Main Conference and General Sessions


7:30 AM - Continental Breakfast


8:00 AM - Chairperson's Opening Remarks


8:15 AM
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


9:00 AM
The Cost of Getting an ELN - Recommendations on How to Minimize your Costs
and Accelerate the Process
Charlie Sodano, Ph.D., Information Services, Berlex Biosciences
Deciding on what the best market solution is for your ELN implementation
can be daunting. In order to begin this process some budget planning is
essential. This session will describe a logical manner, steps on how best
to get a handle on costs.
- Talking to your IT staff first
- Capturing your user needs, then categorizing them
- How can you find appropriate ELN vendors?
- Implementation costs can run wild without appropriate planning


9:45 AM - Refreshment Break


10:00 AM
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?


10:45 AM
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


11:30 AM
End User Cultural and Behavioral Issues: Do End-Users fit the ELN
Requirements?
John Trigg, Chairman AAMG, Royal Society of Chemistry, London.
The success of many IT projects hinges on user acceptance. Projects often
promise business benefit, but deliver user dissatisfaction. Getting to
know, understand and like your users can be as important as developing a
clear business case and choosing the right technologies. This presentation
examines aspects of organizational culture and user behavior and proposes
some practical approaches to help avoid potential pitfalls.


12:15 PM - Close of Main Conference


12:15 PM - Lunch for Post-Conference Participants


Thursday, October 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 Lander, 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 use of a laboratory ELN


II. Learn the Framework for Risk Management
- Why do a risk assessment?
- What are the commonly industry accepted risk management approaches?
- How to apply FTA, HACCP, FMEA and 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
Knowledge Management Methodologies for ELN implementation
Jeff Spitzner, Ph.D. Chief Science Officer, Rescentris
Barry Hardy, Ph.D. CKM, Douglas Connect
InnovationWell Community of Practice Manager; Director, KM Institute,
Switzerland


I. Introduction to Knowledge Management (KM)
- Key Concepts
- Strategic Planning
- Methodologies
- Technologies
- Interactions between ELNs and KM


II. Collaboration and Communities
- ELNs as collaborative R&D support systems
- Role of ELNs in creating and applying organizational knowledge
- Integrating communities of interest and practice
- Intellectual property management during collaboration
- Change management


III. Search, Semantic Web and Ontologies
- Search and classification techniques
- Overview of semantic web life science activities
- Functions of terminologies and ontology's in R&D
- Deploying ontologies in your ELN
- Retrieving knowledge to answer your scientist's questions


IV. Knowledge Café Interactive Exercise
In this exercise, groups will be presented with a test case ELN
implementation and will brainstorm on ideas where knowledge management
approaches could increase the effectiveness of the implementation for
innovative R&D.


V. Knowledge Maps & Processes
- Strategic knowledge gap analysis
- Knowledge resources & processes
- Knowledge mapping tools


VI. Knowledge Management Metrics and Benchmarking
- Performance & cost measures
- Leading & lagging KM Indicators
- KM Metametrics
- KM and balanced scorecard
- Benchmarking solutions & gap analysis


VII. Knowledge Audit
- Readiness, cost, focus and scope of audit
- Human, social & structural capital
- Information systems
- Audit planning and project management
- Information gathering techniques
- Communication and reporting
- Analysis and action plans


VIII. Auditing and Validating KM Practices in ELN Implementations: Case
Studies
- Overview of R&D processes and knowledge management prior to ELN
implementation
- Methodologies used to assess organization
- Impact of ELN implementation on organizational knowledge processes
- Developing a strategy to audit and validate the ELN implementation
- Key assessments: record-keeping and compliance, risk management, business
process improvement
- Continuous improvement


IX. Interactive Exercise
In this exercise breakout groups will be presented with a test case ELN
implementation and will draft a summary of the key issues and critical
processes that should be prioritized by a knowledge audit of the R&D
organization.


Interactive Workshop I 1:30 PM - 5:00 PM
Records Management Program Assuring Regulatory Compliance and Archived
Records Retrieval
Charlie Sodano, Ph.D., Information Services, Berlex Biosciences


I. Records Essentials
- What are records?
- What is the purpose of records?
- Improving efficiency of laboratories
- Learning to catagorize records based on business and regulatory needs
- Learning to manage the life cycle of your records


II. Compliance to FDA Requirements
- Understanding current FDA requirements for record retention

- Learning about recommendations from FDA sources about managing stability
testing records
- Gaining insight into future regulatory requirements


III. Evolution of Electronic Notebooks
- Learning about the history and evolution of ELNs from the 1970's
- Understanding LIMs systems do not provide adequate records management
- Reviewing the ELN products currently on the market
- Understanding the future direction of ELNs


IV. Records Archiving to Assure Future Usability and Compliance
- Learning about international models and standards for archiving
- Reviewing options for long term preservation
- Considering the choices for hardware and software that will be most
efficient


V. Interactive Exercise
Participants will help pick the best strategies for short term (2 - 7
years) and long term (7 - 50 years) storage of records from many options.
Participants will take home the following Bonus Information:
- Best practices for handling and storage of electronic media.


5:00 PM - Close of Day Three


Friday, October 21, 2005
Post Conference 90-Minute Sessions


7:30 AM - Continental Breakfast


Interactive Session 9 8:30 AM - 10:00 AM
Legal Issues Regarding Laboratory Notebook Records
Maureen Gibbons, Patent Counsel, Bristol-Myers Squibb Co.


I. Fundamentals of Laboratory Notebook Keeping Practice
- Understanding the basic 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 be viewed by the patent office and
courts?
- Improving the overall chances for having admissible and credible ELN
records
- Interim solutions for maintaining electronic records in the absence of an
"approved" ELN


III. Interactive Exercise
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 10 8:30 AM - 10:00 AM
Vendor Audits: A Look Under the Hood of Software Development
Virginia L. Corbin, Manager, Corporate Compliance Marketing, Waters
Corporation


I. Why Audit?
- What do the regulations say?
- FDA Findings about software
- Specific risks for computer systems


II. Where to Begin?
- The Validation Master Plan
- Risk-based approach
- Risk project plan
- Rating suppliers
- Who and when to audit
- Purpose of the audit


III. Pre Audit
- Gathering information
- Analysis
- Creating checklists


IV. What to Look for During the Audit
- SDLC approach
- Compliant ready software
- Tracing requirements
- Choice to an on-site audit


V. It's Over, Now What?
- Documentation to meet federal guidelines
- Unexpected results
- When to audit again
- References


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 stand-lone system
- Benefits of data reuse
- Using an ELN as part of an integrated system
- Reintegration of the research record


II. Designing 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 a 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.


10:00 AM - Refreshment Break


Interactive Session 12 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
- Steping 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
- 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
- Addressing ephemeral data issues
- The impact on ELNs of downstream clinical/patient data


Interactive Session13 10:30 AM - 12:00 PM
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 are the differences among 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.


Interactive Session 14 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
Hilton Dublin
Charlemont Place, Dublin 2, IE
Ph: 353-1-4029988 - Fax: 353-1-4029966
www.dublin.hilton.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 - October 18-21, 2005 - Dublin, Ireland


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 218.723.9130 (U.S. or international) - Fax:
218.723.9308
E-mail: Registration at ivthome.com


Tuesday, October 18, 2005
Pre-Conference Half-Day Workshops


      8:30 AM - 12:00 PM $895 USD
      A n__ B __ C __ (Choose one)


__Tuesday - Thursday, October 18 - 20, 2005
MAIN CONFERENCE: General Sessions & Inclusive Interactive Sessions $2095
USD


      Please choose one breakout workshop in each timeframe.


      Tuesday, October 18, 2005 Interactive Sessions:
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      3:30 PM - 5:00 PM (Choose one)
      5 __ 6 __ 7 __ 8 __


      Wednesday, October 19, 2005 Interactive Workshops:
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      D __ E __ F __


Thursday, October 20, 2005 Post-Conference Workshops:


      1:30 PM - 5:00 PM (Choose one) $895 USD
      G __ H __ I __


__Friday, October 21, 2005 Post-Conference


      90-Minute Sessions (Choose one per time period)
      8:30 AM - 10:00 AM $495 USD
      9 __ 10 __ 11 __


      10:30 AM - 12:00 PM $495 USD
      12 __ 13 __ 14 __


__The Ultimate Passport $2695 USD (Attend the entire event at this best
value price.)


      The Passport Includes:
      - One Pre-Conference Workshop
      - Main Conference Tuesday through Thursday
      - One Post-Conference Half-Day Workshop
      - Two Post-Conference Interactive Sessions
      - Networking Cocktail Reception
      Passport registrants must check the boxes of the workshops and
      sessions they wish to attend!


Multiple Registrations: Send three attendees and the fourth is FREE!


Early Bird Discount: Register early. Payments received byAugust 30, 2005
will be given a 10% discount.


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
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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 October 4, 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.





You MUST mark the sessions and workshops you will be attending.
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COST TOTALS


      Tuesday, October 18, 2005
      Pre-Conference Workshops A - C $895. USD $ _____________


      Tuesday - Thursday, October 18-20, 2005
      Main Conference includes
      Sessions 1 - 8 and Workshops D - F $2095. USD $ _____________


      Thursday, October 20, 2005
      Post-Conference
      Half-Day Sessions G - I $895.. USD $ _____________


      Friday, October 21, 2005
      Post-Conference Interactive
      Sessions 9 - 14 _____ X $495.. USD $ _____________
      OR


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      TOTAL Enclosed $ _____________



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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)
218-723-9477 (products and journals)
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Fax: 218-723-9308
Advanstar Communications
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