GXP

Application of Validation Principles to The Training Quality System. Part 6, Continued Training Verification

INTRODUCTION This paper continues a series of previous discussions (1-5) comprising the application and integration of validation principles to the training quality system.  The lifecycle approach to manufacturing process validation and related validation/qualification concepts are proposed for application to training.  Approaches described provide organization and structure to a site training program. This discussion addresses the ongoing monitoring of trained employee performance – equivalent to stage 3 of the lifecycle approach to process validation.  Previous discussions...

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