Validation Sampling Plans, Setting Acceptance Specifications and Statistical Process Control
This workshop will explore the topic of setting appropriate sampling plans and using those plans to set appropriate acceptance criteria for process validations. Using a 5 step method, the attendee will come away with a good understanding of sampling for validation including using risk to make sampling decisions. It will also explore using variance to set acceptance criteria for test method validation. Lastly, we will take a look at using statistical process controls to ensure our process is maintained in a validated and controlled state.Areas CoveredWhat is sampling?Validation sampling vs. lot acceptance samplingSetting up a validation sampling plan 5-step methodUsing sampling plans to set acceptance criteria for process validationsSetting acceptance criteria for test method validation Variance: How much is too much?How to measure variance and why?Use of process capability to set acceptance criteria Statistical process control and maintaining a controlled stateCourse Level - IntermediateWho Should AttendR&D scientists involved in method validation, validation quality, validation engineers, manufacturing, and quality control teams involved in invalidations.Why Should You Attend Proper validation of processes and test methods is required by regulations for all pharmaceutical and medical device manufacturers. Setting appropriate sampling and acceptance criteria is essential to successful validation.Topic BackgroundThis webinar will cover designing sampling plans for process and test method validation and using those sampling plans to set acceptance criteria. A discussion of statistical process controls will help ensure you stay in a validated state.
Single
This workshop will explore the topic of setting appropriate sampling plans and using those plans to set appropriate acceptance criteria for process validations. Using a 5 step method, the attendee will come away with a good understanding of sampling for validation including using risk to make sampling decisions. It will also explore using variance to set acceptance criteria for test method validation. Lastly, we will take a look at using statistical process controls to ensure our process is maintained in a validated and controlled state.
Areas Covered
- What is sampling?
- Validation sampling vs. lot acceptance sampling
- Setting up a validation sampling plan 5-step method
- Using sampling plans to set acceptance criteria for process validations
- Setting acceptance criteria for test method validation
- Variance: How much is too much?
- How to measure variance and why?
- Use of process capability to set acceptance criteria
- Statistical process control and maintaining a controlled state
Course Level - Intermediate
Who Should Attend
R&D scientists involved in method validation, validation quality, validation engineers, manufacturing, and quality control teams involved in invalidations.
Why Should You Attend
Proper validation of processes and test methods is required by regulations for all pharmaceutical and medical device manufacturers. Setting appropriate sampling and acceptance criteria is essential to successful validation.
Topic Background
This webinar will cover designing sampling plans for process and test method validation and using those sampling plans to set acceptance criteria. A discussion of statistical process controls will help ensure you stay in a validated state.
