Validation Sampling Plans, Setting Acceptance Specifications and Statistical Process Control
Alan has over 30 years of experience in the medical device industry, both in basic research and in 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 wherein both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
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. Alan received his BS degree in Microbiology from
the University of Michigan and his MS degree in Molecular Biology and
Immunochemistry from the University of Illinois.
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.
Setting up an appropriate sampling plan for process validations and setting appropriate acceptance criteria for process and test method validation is critical for successful validation activities.
- What is a 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 - This webinar will be appropriate for anyone just beginning validation activities as well as more experienced professionals.
Who Should Attend
Quality Assurance Professionals, R&D Scientists, Technical Support Scientists, Regulatory Affairs Professionals, Manufacturing and Production Personnel involved in validation activities
Why Should You Attend
webinar will be useful to validation engineers, R&D scientists,
quality professionals and production personnel involved in invalidation
activities. Validation professionals in both medical device and
pharmaceutical industries will benefit.