Process and Test Method Validation, using variation and sampling to set acceptance criteria
This webinar will describe using variance components and risk based statistical sampling plans to set acceptance criteria for test method and process validations.
Webinar Outline:
- Why validate
- Brief review of what validation means
- Brief review of regulations and guidance around validation
- The concept of acceptance criteria
- What is it?
- Why do you need it?
- Setting acceptance criteria for Test Method Validation
- Concept of process capability
- Using capability to set acceptance criteria
- Setting acceptance criteria for Process Validation
- The concept of acceptance sampling
- Acceptance sampling for process validation
- Risk based acceptance sampling
- Using acceptance sampling to set acceptance criteria
Speaker:
Alan Golden, MS, Principal, Design Quality Consultants, LLC
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 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.
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.
Why you should attend the session:
Setting appropriate acceptance criteria for validation is critical to assure that the test method and process meets the needs of the product and end user.
Who Will Benefit from this Webinar:
This seminar would be appropriate for Pharma, Biotech, and Medical Devices
Who Should Attend:
This webinar is for professionals in the Pharma, Biotech, and Medical Devices industries with responsibilities in the following areas:
- Quality Systems
- Quality Assurance
- Quality Control
- Engineering
- Validation
Registration Information:
The registration fees for IPA webinars/online events are per person basis, whether delegates are attending together from a conference room or from separate locations.
1 Attendee: $208 + HST CAD per session
2 Attendee: $356 + HST CAD per session
3 Attendee: $488 + HST CAD per session
4 Attendee: $589 + HST CAD per session
5 Attendee: $658 + HST CAD per session
To register for a Group of 6 or more, please contact us at enquiry@ipacanada.com
Log in information will be provided 24-48 hours prior to the webinar.
All participants will receive an e-Certificate of training 2 weeks after the live presentation.
