ComplianceOnline

Computer Validation Foundations: Common Sense Practices for Compliance

Instructor: Teri Stokes
Product ID: 700710
  • Duration: 60 Min

recorded version

$249.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
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Read Frequently Asked Questions

An industry standard format for test plan and test summary report will also be discussed in this presentation.

Description

Examples from real projects will be used to illustrate the concepts discussed.

Formal testing practices must be followed in order for a testing effort to be properly documented and ready for successful audits and inspections. These practices begin with a management approved user requirements specification (URS) and end with a traceability matrix of test scripts back to each requirement. There are specific roles and responsibilities for a test script author, reviewer, tester, and witness. The test script needs to include specific elements and testers need to follow specific guidelines when completing a test script. An industry standard format for test plan and test summary report will also be discussed in this presentation. Examples from real projects will be used to illustrate the concepts discussed.

Areas covered in the session:

  • Role and structure for user requirements specifications (URS)
  • Role and structure for test script traceability matrix
  • Roles and responsibilities for test coordinator, test script author, reviewer, tester, and witness.
  • Industry standard outlines for test plans and test summary reports.
  • The different types of testing performed by software developers (OQ), IT analysts (IQ), and end users (PQ).
  • What auditors expect to see

Who will benefit:

  • System validation teams
  • QA & QC professionals
  • Software suppliers selling into Bio/Pharmaceutical markets - QA , QC , SDLC managers
  • IT managers and staff
  • End user purchasers of computerized systems for use in regulated environments – GCP, GLP, GMP, 21 CFR Part 11
  • Auditors and consultants

Instructor’s Profile:

Since 1996 Dr. Stokes has had a successful global consulting practice in computer validation as GXP International. This practice benefits from a background of 16+ years in the computer industry at Digital Equipment Corporation based in the USA and also in Switzerland as well as 12 years as a registered Medical Technologist working in hospital, university, and central medical laboratories. She has authored two books and many invited chapters and journal articles on the subject of common sense computer validation practices.

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