Validation Sampling Plans, Setting Acceptance Specifications and Statistical Process Control
Alan has over 35 years of experience in the medical device industry, both in basic research and quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
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.
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$200.00
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