2-day workshop: Statistics & Risk Analysis Using USP 1210 and 1010

  • Day 1: October 21, 2020
    9:00 am - 12:00 pm
  • Day 2: October 22, 2020
    9:00 am - 12:00 pm

Certification Areas

The Goal of the Course

To learn how to use the statistical tools presented in USP General Chapter <1010> Analytical Data—Interpretation and Treatment published in USP PF 44(5), and USP <1210> Statistical Tools for Procedure Validation. Learn how to use these statistical tools to meet the requirements of proposed USP <1220> The Analytical Procedure Lifecycle.


Statistical Tools

The specific statistical tools that you will learn include confidence intervals and tolerance intervals. What is the difference between them? You will learn which tool to use in your method validations and learn to understand what each tool is telling you about your method.


Acceptance Criteria for the Statistical Tests

The statistical tools presented in <1010> and <1210> all require acceptance criteria when they are used. These criteria can be stated clearly through the Analytical Target Profile (ATP). The course will begin by explaining how the ATP is used to establish the acceptance criteria.


Fit for Intended Use

The acceptance criteria are based on “Fit for its intended use”. The recent focus of USP chapters and FDA guidance is that the analytical procedures must be developed and qualified based on a clear understanding of their use so that the analytical procedures will be fit for use. This involves the use of decision rules, probability, and Target Measurement Uncertainty (TMU), and the analytical target profile (ATP). In addition, the analytical procedure development and qualification must provide a control strategy that will continually verify the analytical procedure is performing as expected during routine use.


Risk Control

The control strategy is created by identifying the risks to the analytical procedure and implementing adequate controls. This is an outcome of evaluating the measurement uncertainty.


The course will be taught in the context of these new concepts.


Approach to Training

This will be a webinar presented in 2 parts. There will be an opportunity for questions and answers.


SPEAKER: Jane Weitzel

Jane Weitzel has been working in analytical chemistry for over 40 years for pharmaceutical and mining companies.  She is currently a consultant specializing in laboratory management systems, GMP testing, and ISO/IEC 17025. She is an auditor and an educator. Jane has applied Quality Systems and statistical techniques, including the evaluation and use of measurement uncertainty, in a wide variety of technical and scientific businesses. She has obtained the American Society for Quality Certification for both Quality Engineer and Quality Manager.

Jane was elected to the USP Council of Experts as a member of the USP Council of Experts and chair of the 2020-2025 General Chapters–Measurement and Data Quality Expert Committee. She was a member of the USP 2015-2020 Statistics Expert Committee and past member of the USP Expert Panel on Method Validation. She has been Director of pharmaceutical Quality Control laboratories. She has experience with many different regulatory environments.


Registration Deadline: 18 Oct 2020

Student Ticket: $200.00 Sold Out
Basic Member Regular: $445.00 Sold Out
Pro Ticket Regular: $395.00 Sold Out