Making Statistically-Valid, Risk-Based Decisions
Tuesday, May 20, 2014 @ 11:00 AM Eastern
This webinar series is targeted to professionals concerned with the application of Sampling Plans to satisfy the requirements of the FDA’s Quality System Regulation. Sampling Plans are key statistical methods used for Process Validation and for Receiving, In-Process, & Finished Device Acceptance. The presentations will discuss the recommendations of the guidance documents developed by the FDA and the Global Harmonization Task Force (GHTF).
These fast-paced webinars will cover the details of application together with some examples of best practices in industry. Analysis results from popular statistical software programs will be illustrated. The presenter’s “keep-it-simple” approach will avoid statistical complexity—participants do not need to have a background in statistics.
This is the first of three webinars on this key subject. This webinar will first focus on Sampling Plans that are vital to approving a new production process. As such, it will answer the frequently asked question: “How many production lots or batches should we sample for a new process?” It will then introduce fundamental concepts for Acceptance Sampling Plans. The second and third webinars will focus on variable and attribute Acceptance Sampling Plans. An optional exam will be available after each webinar to demonstrate proficiency in the material presented.
The key to creating and applying Sampling Plans is to quantify the risks involved in making a decision on the quality of a product or process. At the end of this first of three webinars, participants will be able to:
•Create a risk-based Sampling Plan for a new production process
•Describe the factors that influence sample size selection
•Apply fundamental statistical methods and tools for analyzing a new production process
•Formulate risk-based decisions on the quality of a product or process
•Define the fundamental concepts for Acceptance Sampling Plans
• Peter Knepell, PhD, President, Peak Quality Services
AAMI Faculty Member for: Process Validation; Risk Management; Statistical Methods & Tools; and Design of Experiments
CLICK HERE for additional information and to register.
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