Computerized System Validation (CSV)

Venue: Richmond Hill

Location: Richmond Hill, Ontario, Canada

Event Date/Time: Jun 22, 2011 End Date/Time: Jun 23, 2011
Registration Date: May 31, 2011
Early Registration Date: Apr 30, 2011
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Learning Objectives

  • Analyzing system requirements: What functionality is actually needed and will be highly effective in increasing productivity?

  • Developing  test approaches that prove system operation and system performance

  • Functional Requirements and Specifications

  • Detailed Design Specifications

  • Installation, Operation, and Performance Qualifications (I/O/PQs)

  • Evaluating software development vendors: What are the best technical and long-term resources to developing custom software applications

  • System Development Life Cycle (SDLC)

  • Validation of Spreadsheets

About the Program

Strategies for Achieving and Maintaining Part 11 Compliance in Today's Current Practices

Software and computer system validation is required by regulations and it is important to ensure system uptime during ongoing use. Despite of more than 30 years experience and availability of FDA and industry guidance, computer validation still confuses people. To echo modern computer technology and development techniques, computer validation practices need to be updated.

Here at IPA we are pleased to draw together recognized industry subject experts to address today's current compliant practices on validation of computerized system and taking the attendees through effective processes on how to successfully manage, gather, analyze, specify and document validation and for implementing the 21 CFR 11 regulation.

Practical examples, case studies and collaborative exercises will be dispersed into and between the presentations. In completion of this program, the delegates will gain valuable validation knowledge and tools to optimize the entire process and excel in their job.

During this two-day interactive event you learn about:

  • Functional Requirements and Specifications

  • Detailed Design Specifications

  • Validation Plans, SOPs, Protocols and Reports

  • Installation, Operation, and Performance Qualifications (I/O/PQs)

  • Traceability Matrix

  • Testing Execution

  • Validation Summary Report

  • Risk Assessment Tools

During this two day event the following topics will be addressed:

  • Computer System Validation Regulatory Requirements

  • Computer Validation Process and Deliverables

  • Validation Plans and Master Validation Plans

  • Functional Testing (How much is enough?)

  • System Development Life Cycle (SDLC)

  • Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities

  • Computer System Vendor Qualification, and Vendor Audit Checklist

  • Computer Infrastructure Security

  • Maintaining the State of Qualification

Plus Workshops On:

  • Validating a Laboratory Instrument

  • Validating and Use of Excel Applications

  • Validation Program Design & Management


420 Highway #7 East, Box 82022