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Implementing the Key Elements of Validating a Production Isolator System (Presentation) by Les Edwards, MSE January 24-25, 2002
 
An overview of the key aspects of validating a production isolator system is reviewed with an emphasis on relating design documentation to validation plans and protocols.
 
Practical Validation Strategies for Isolated Sterility Testing Labs - Part I (Presentation) by Les Edwards, MSE June 13-14, 2002
 
This workshop thoroughly reviewed the overall design process and equipment qualification methodology for isolator systems utilizing gaseous decontamination methods. Key learning objectives included determining your capacity requirements, developing a validation master plan, facility classification requirements, and qualifying your isolators and related process equipment.
 
 

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