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Live -Webinar 2014 - Maintaining a Validated State ? PV, PM and Statistics associated with Current Regulation
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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.
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.
Other CFPs
- 2014 the 3rd International Conference on Mechanical Engineering, Materials Science and Civil Engineering (ICMEMSCE2014)
- ISITE-International conference on Recent Advances in Science, Engineering and Technology
- IGRFORUM-International conference on Recent Innovations in Science Engineering and Technology
- IGRFORUM-International Conference on Recent Innovations in Electrical, Electronics, Computer and Mechanical Engineering
- IITR-International Conference on Electrical, Electronics, Computer Science, Management and Mechanical Engineering
Last modified: 2014-08-13 19:08:32