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.
Why should you attend
Process knowledge and understanding is the basis for establishing and approach to process control for each unit of operation specific to equipment variables in order to generate overall process control needed for validation. The current majority of serious warning letters and consent decrees have been issued against companies with years of experience but an overall miscomprehension of the validation expectations. Is a validated process that has a significant number of OOS batches considered a validated process? A system or systems for detecting unplanned departures from the process as initially designed or currently operated is essential to accomplish this objective.
Educating the Experienced
How do we teach old dogs new tricks?
How do we teach new dogs new tricks?
We have to know what the objective is, what tools we have in our tool-box, know how to use them and demonstrate the confidence to apply them.
How to get more bang for your buck (validation is a cost savings program, but validation is viewed by executives as serious expense that would like to be avoided)
Randomized Block Statistical Model for Effective Validation
Grouping to have the units in a block as uniform as possible so that observed differences will be largely do to treatment and make root cause analysis simple and accurate.
Measure uniformity within a loaded sterilizer chamber and at the same time map the chamber….in two runs we can tell as much about the performance of the sterilizer using a randomized block experimental design as is normally with a dozen or so experimental temperature distribution and heat penetration runs.
Uses randomization, an expectation of uniformity, analysis of variance and an equally likely chance for each location to have an independent lethality value of all other locations in the chamber.
Areas Covered in the Session
Continued monitoring and/or sampling at the levels established during the development and qualification stages until sufficient data is available to generate statistically significant variability estimates. Once the variability is known, sampling and/or monitoring should be adjusted to a statistically significant level. Variation is to be used to detect the potential for defect complaints, OOS including OOT and OOL results, including deviation reports, process yield variations, BPR deficiencies, incoming raw material variances, adverse events and many other issues that may be found to enhance a validated (cost effective with minimal patient risk) means of operation. Hence change control becomes a critical component using SSR (sound scientific rationale) to manage an on-going validated state.
Appropriate Application of Simple Statistical Tools, the Scientific Methods, facts, theories, proposals, functional requirements (FRS), acceptance criteria, formation of a hypothesis that is logical with sound scientific rationale by being scientifically based making it defendable.
Objective Evaluation - To most scientists, statistics is logic or common sense with a strong admixtur
Why should you attend
Process knowledge and understanding is the basis for establishing and approach to process control for each unit of operation specific to equipment variables in order to generate overall process control needed for validation. The current majority of serious warning letters and consent decrees have been issued against companies with years of experience but an overall miscomprehension of the validation expectations. Is a validated process that has a significant number of OOS batches considered a validated process? A system or systems for detecting unplanned departures from the process as initially designed or currently operated is essential to accomplish this objective.
Educating the Experienced
How do we teach old dogs new tricks?
How do we teach new dogs new tricks?
We have to know what the objective is, what tools we have in our tool-box, know how to use them and demonstrate the confidence to apply them.
How to get more bang for your buck (validation is a cost savings program, but validation is viewed by executives as serious expense that would like to be avoided)
Randomized Block Statistical Model for Effective Validation
Grouping to have the units in a block as uniform as possible so that observed differences will be largely do to treatment and make root cause analysis simple and accurate.
Measure uniformity within a loaded sterilizer chamber and at the same time map the chamber….in two runs we can tell as much about the performance of the sterilizer using a randomized block experimental design as is normally with a dozen or so experimental temperature distribution and heat penetration runs.
Uses randomization, an expectation of uniformity, analysis of variance and an equally likely chance for each location to have an independent lethality value of all other locations in the chamber.
Areas Covered in the Session
Continued monitoring and/or sampling at the levels established during the development and qualification stages until sufficient data is available to generate statistically significant variability estimates. Once the variability is known, sampling and/or monitoring should be adjusted to a statistically significant level. Variation is to be used to detect the potential for defect complaints, OOS including OOT and OOL results, including deviation reports, process yield variations, BPR deficiencies, incoming raw material variances, adverse events and many other issues that may be found to enhance a validated (cost effective with minimal patient risk) means of operation. Hence change control becomes a critical component using SSR (sound scientific rationale) to manage an on-going validated state.
Appropriate Application of Simple Statistical Tools, the Scientific Methods, facts, theories, proposals, functional requirements (FRS), acceptance criteria, formation of a hypothesis that is logical with sound scientific rationale by being scientifically based making it defendable.
Objective Evaluation - To most scientists, statistics is logic or common sense with a strong admixtur
