"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Test Method Validation (TMV) Made Easy
Part 2 of 2 Click here for Part 1 »
Note. Attending the first webinar on TMV is NOT a requirement to attend this webinar.
In the previous webinar we asked: “How do you know you have quality if you cannot reliably measure what you are doing?” This second webinar will focus on Attribute Measurement Systems – that is, the subjective inspection of items to see if they satisfy requirements. Since humans are the “gauges”, attribute measurement systems can have high variation. How do you evaluate this human judgement and how can you improve their results? And how is it “made easy”? This webinar will provide simple metrics to evaluate the human performance and industry best practices to reduce variation. It’s as simple as that!
Test Method Validation (TMV), also known as: Measurement System Analysis (MSA) and Gauge R&R (GR&R). The name is not important, the application of this very valuable statistical methodology is essential for a quality system. The material covered in this webinar is completely independent of the first webinar on Variable TMV. Thus, attending the first webinar on Variable TMV is NOT a requirement to attend this webinar.
Attribute measurements typically end up with a “Pass/Fail” or “Accept/Reject” decision. This webinar provides a very practical approach to conducting Attribute TMVs. Participants will gain a working knowledge of how to organize an Attribute TMV, collect data, analyze the results, and improve the measurement system.
The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do NOT need to have a background in statistics.
This webinar is targeted to professionals concerned with the application of valid statistical methods and tools to satisfy the requirements of the FDA’s Quality System Regulation and ISO 13485:2016. In particular, the Attribute TMV methodology is important for Design Control and Process Validation.
This webinar will provide a working knowledge of the principles and application of Attribute TMV/MSA/GR&R. As such, participants will:
- Learn the quality metrics and industry standards used to evaluate the effectiveness of a measurement system
- Understand how to quickly analyze results, diagnose problems, and improve a measurement system
- Understand how to apply this valuable methodology in Design Control and Process Validation
- Learn some techniques to deal with destructive testing
- Review of Questions from Part 1 Webinar on Variable TMV
- Destructive Testing – Four Techniques from Industry
- Address Emailed Questions
- Fundamentals of Attribute TMV/MSA/GR&R
- Definitions & Terminology
- Quality System Regulation & Guidance Documents
- Significant Trends and FDA Warning Letters
- How to Run an Attribute TMV
- Organizing an TMV
- Conducting an TMV
- Improving an Attribute Measurement System
- Industry Best Practices
- Technical Details
- Attribute TMV Metrics
- Sample Size
- Question and Answer Period
Who should attend:
This webinar is targeted to professionals concerned with the application of valid statistical tools and methods to meet the requirements of the FDA's Quality System Regulation. As such, the content should have great value to individuals in industry who are involved with: research and development; new product development; process development; manufacturing, process, and quality engineering; operations; quality assurance; and regulatory compliance. In addition, managers and members of the leadership team will see how value is added to a product or process by applying this valuable methodology.
There are no prerequisites for these webinars. No background in statistics is necessary. That is the foundation of our "keep-it-simple" approach.
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »
Bring this course in-house?
Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?
If so, running the course in-house is probably the best and most cost effective solution.
Peter Knepell, PhD
October 14, 2019
14.30 - 16.30 (120 min) CET (Central European Time)
Price (excl. local VAT):
250 Euro for the first participant.
115 Euro for the following participants on the same registration and invoice.
Course handouts (PDF) and certificate of attendance is included.
For larger groups, please contact us for an offer.
You need access to a computer, tablet or mobile phone with internet connection (preferably min 700kB/s) and audio capabilities (speakers or headphones).
We are using the easy to use application "GoToMeeting".
See more about how it works and system requirements here »
Instructions will be attached to your order confirmation.
Cancellation policy for webinars:
Cancellations received less than 24 hours before the webinar will be charged 50% of the course fee.
If you for any reason is unable to attend, substitution is always possible and preferred. All cancellations and/or substitutions must have been communicated with and confirmed by us.
In case of failure to cancel before the course, the course fee will be charged in full.
Cancellation of webinars:
Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value.