ComplianceOnline

How to Use the System Risk Level to Save Time and Money on Computer System Validations

Instructor: Tim Stein
Product ID: 700357
  • Duration: 60 Min

recorded version

$149.00
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Training CD

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In this seminar, you can learn how to save time and money in conducting validations that fully meet regulations

Description

The FDA guidelines urge regulated companies to base validation efforts on the risks associated with system failures. Yet most companies do the same thing to validate each of their systems.

A risk based-approach is the most significant means to gain efficiencies in the validation of moderate- and low-risk computer systems. The FDA guidelines urge regulated companies to base validation efforts on the risks associated with system failures. Yet most companies do the same thing to validate each of their systems.

In this seminar, you can learn how to save time and money in conducting validations that fully meet regulations. In a recent validation of an ERP system, for example, a risk based approach resulted in the need to test only 20% of the requirements related to regulatory activities.

In this second of two related webinars, Tim Stein will review the computer system validation activities and discuss:

  • Which of the activities need to be performed for low- and high-risk systems
  • How to modify the rigor and intensity of the validation efforts based on the risk level
  • The level of testing that is appropriate for low-, moderate-, and high-risk system

This presentation is based on the RiskVal(SM) Life Cycle described by Tim in his recent book: The Computer System Risk Management and Validation Life Cycle. This volume was published in 2006 by Paton Press. See [www.patonpress.com]

An ERP system is used as an illustration throughout the presentation.

In the first webinar of this series, Assessment of Computer System Risk as a Basis for Validation, Tim Stein presented methods for determining the system risk level, and risks associated with the failure of a computer system to meet requirements. These analyses are assumed in this second webinar.

Areas Covered in the seminar:

  • What validation activities are appropriate for low-, moderate-, and high-risk systems
  • How to adjust the rigor and intensity of validation activities based on the system risk level
  • How to base the level of requirements testing on the risks associated with system failures

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • End-users responsible for applications that need to be validated
  • QA managers and personnel
  • Information Technology managers and personnel
  • Validation specialists
  • Consultants
  • Quality system auditors

Instructor Profile:

Tim Stein, Ph.D., is the founder and CEO of Business Performance Associates, Inc. (BPA), a consulting firm that specializes in both quality systems for biomedical companies and computer system validation. Tim is the author of Computer System Risk Management and Validation Life Cycle which is scheduled for release in April 2006 by Paton Press. Tim has written a set of policy and procedure documents and templates for computer system validation that are available through ComplianceOnline.

Tim brings a rare combination of knowledge to computer system validation. He has in-depth knowledge of software engineering, computer system implementation, the regulatory requirements and guidance documents for software development and validation, and quality system requirements. In the late 80’s, as a quality manager with Tandem Computers, Tim was responsible of supporting 250 software development companies in improving the quality of their products. For the past twelve years, Tim has helped regulated companies establish compliant quality systems and validate computer systems. He also has help companies obtain the ability to validate systems by providing tools and training.

Related Documents:

1. Life Cycle for the Selection, Implementation, Validation and Use of Computer Systems (RiskVal Life Cycle)

2. Computer System Risk Evaluation for Determining Risk Mitigations, Validation Activities, and the Extent of Testing (RiskVal)

3. Guidance on Validation Activities for Systems at the Low-, Moderate-, and High-Risk Levels (RiskVal)

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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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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