Recorded Date: September 2004
Course Type: Recorded On-line Seminar

Speakers:
Lorrie Vuolu-Scheussler
Kathy Gniecko 

In this Recorded On-line Seminar, participants will learn strategies to eliminate "one size fits all" validation. We will discuss new methodologies for developing a strategy for validating laboratory instrumentation that is appropriate for the complexity of the system.

This Recorded On-line Seminar will provide participants with an overview of the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems. Participants will receive an overview of the key themes and concepts of the guide, including laboratory system categorization, development vs implementation life cycles, and a risk assessment model. The GAMP software categories are but one of the factors that should be considered when defining an appropriate approach to the validation activities for a laboratory system.

The GAMP software categories, along with further laboratory system categorization based upon technical complexity and intended use, and risk assessment processes can be used to determine a rational validation strategy to appropriately scale laboratory validation efforts.

Learning Objectives
At the end of this Recorded On-line Seminar, participants will be able to:

• Examine traditional SDLC and its applicability for most laboratory computerized systems
• Identify characteristics which distinguish various laboratory computerized systems
• Develop rational for the scaling of the efforts associated with the validation of laboratory computerized systems
• Develop a strategy of vendor assessment, which supplements company-specific validation activities
• Refine GAMP 4 risk assessment approach to be applied to computerized laboratory systems
• Define necessary controls to maintain laboratory computerized systems in a validated state
• Recommend activities to be performed when a laboratory computerized system is no longer suitable for its intended use

Who Should Attend

• Laboratory, quality and computer validation professionals responsible for defining and managing laboratory validation practices in regulated industries
• IT personnel supporting these systems
• Management and laboratory system users who are an integral part of the validation process
• Software developers.

 Purchase from ISPE's On-line Store