91AV

Introduction

Validation is a continuous improvement journey; it is not a voyage of discovery or successfully completing three conformance lots. Hence the means by which we identify the elements that need to be "validated” are often missing a few steps in the operational, cycle development and performance qualification that after we move into a normal operation may require a re-assessment as per the current PV guideline (evaluating the performance of the process identifies problems and determines whether action must be taken to correct and re-validate, anticipate, and prevent problems so that the process remains in control). This includes an on-going review of the originally defined Critical Steps, Product Test Data, Change Control, and OOS, OOL and OOT incidents which all have to be included in the Annual Product Review to demonstrate an acceptable validated state of operation and process control.

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Venue

Online

Online, 10777 Westheimer Suite 1100, Houston, Texas, USA, 77042, Houston, 77042, United States

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Organised by

compliance2go

Contact information

compliance2go
10777 Westheimer Suite 1100, Houston, Texas, USA, 77042, Houston, 77042, United States of America
(877) 782-4696
Contact us by email

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