ComplianceOnline

Computer Validation Foundations: Common Sense Practices for Compliance

Instructor: Teri Stokes
Product ID: 700709
  • Duration: 60 Min

recorded version

$249.00
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2008

Training CD

$500.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

The mutually exclusive roles for Quality Assurance and Quality Control in validation will also be discussed.

Description

Across 20+ years of global regulations and guidance related to computer systems, there are four common themes that provide the foundation for auditable validation efforts.

System validation documentation must provide evidence for three areas of activity and testing is only one of them. The content of a validation package is different for end user performance qualification (PQ) of systems in their work process, for IT installation qualification (IQ) of infrastructure, and for a software supplier's operational qualification (OQ) of a newly developed product. The mutually exclusive roles for Quality Assurance and Quality Control in validation will also be discussed. The emphasis is on experience-based approaches that are known to have worked

Areas Covered in the seminar:

  • The four major themes common to all computer related regulations
  • A common strategy for preparing all computer validation packages
  • Variations on the common strategy for preparing auditable OQ, IQ, and PQ packages
  • Industry standard outlines for Validation Plans and Test Plans and why you need both types of plans
  • Audit criteria for reviewing computer validation documentation
  • The roles of QC and QA in computer validation

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 Profile:

Teri Stokes, 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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