Statistical
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Measurement Systems Analysis
Calibration (accuracy) has been traditionally required by ISO 9001, but measurement systems analysis (precision) has not – although it has been an element of the automotive standard IATF 16949 ever since the latter was QS 9000. Accuracy and precision... -
Measurement Uncertainty in Microbiology
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples. Laboratories are often confused about... -
Method Validation – Utilizing Quality by Design (QbD) and Risk in Implementation
Pharmaceutical industry is experiencing a growing need to improve performance driven by global competition and the increasing impact of information technology. FDA’s Process Validation Guidance calls for continued process verification which applies to both manufacturing and measurement processes. How... -
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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 Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures... -
Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation
Attendees of this webinar will learn statistically valid methods for using small sample sizes and for using lots as few as 3 when validating processes or products. The focus of this webinar is on providing the information needed for... -
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...
