Statistical
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Metrology: Statistical Analysis of Measurement Uncertainty
The seminar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and “uncertainty ratios”. Several of the standard methods for analyzing measurement variation are then described and explained, as derived... -
Power Analysis for Sample Size Calculations
In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation. Also attendees will get work examples in the free to use G*Power software. Some code and demonstrations will be... -
Process Capability Analysis using Confidence or Reliability Calculations
Testing and/or inspections to determine whether or not a product or a lot is acceptable vs. design or QC specifications are performed by all manufacturing and development companies. These test/inspections may happen during design verification/validation or during incoming or... -
Sampling – How Large a Sample Do I Need? Determining the Right Size for Accurate, Cost Effective Results
Recent global financial challenges have brought about immense changes to the Pharmaceutical and Biotech industries. In the interest to speed up development and improve their operations for companies the FDA is promoting the use of the Quality-by-Design (QbD) approach.... -
Sampling and Sample Handling in Laboratories
Sampling is an important operation within the entire analytical testing process in which only a small fraction of a product is taken. Valid conclusions on the whole test can only be based on representative sampling. Thorough handling of samples... -
Selecting Right Statistical Tools to Solve Problems
Many pharma and biotech professionals and regulators point out that statistics is a necessary tool and yet many pharma organizations do not make proper use of the tool. Many of the reasons for the slow adoption of statistical thinking... -
Solving Statistical Mysteries – What does the FDA want
This webinar provides an overview of what it appears the FDA is looking for in the use statistics by taking illustrative examples from warning letters and industry experiences and approaches that have worked in a variety of situations. Use... -
Solving Statistical Mysteries – What does the FDA want
This webinar provides an overview of what it appears the FDA is looking for in the use statistics by taking illustrative examples from warning letters and industry experiences and approaches that have worked in a variety of situations. Use... -
Statistical Analysis – Planning, Conducting, Documenting and Reporting
Use of statistics has been part of the FDA’s guidance and regulations for many years. Recent uses include Quality by Design, Process Analytical Technology and the 2011 FDA Process Validation Guidance. Even with this long history, the use of... -
Statistical Justification for Sample Size and the Use of Only 3 Lots for Process Validation
Almost all manufacturing and development companies perform at least some process validation studies, but it is difficult to decide how many Lots to include in the study and how large the Sample per Lot should be. This webinar provides... -
Statistical Power – Understanding, Calculating, and How to Effectively Use it
Statistical power is an indicator of the ability of a test of significance to “detect” a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in... -
Statistical Process Control – Keys to Prevent Process Variation and Ensure Quality
Statistical process control (SPC) is a form of feedback process control that does for discrete manufacturing operations what automatic process control does for chemical process operations. The control chart reveals the presence of special or assignable causes that require... -
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Statistical Process Control (SPC)
All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The most... -
Statistical Process Control (SPC)
All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The most... -
Statistical Tips and Techniques for Handling Missing Data
If you work with data, you should attend this webinar. Real life data is not pretty. It is messy and often incomplete. There are many ways to handle missing data and many of these ways are not the best.... -
Statistics and Data Analysis for Auditors
“The goal is to transform data into information, and information into insight” – Carly Fiorina, former President of Hewlett Packard Too often we make an art form out of collecting data, while the “business” of analyzing it is neglected....