Comparability: Statistical Fundamentals Course Outline

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Who Should Attend: This course is designed for biopharmaceutical professionals at all levels involved in changes during the manufacturing process or product development. Regulatory agencies require evidence to confirm that the process controls in the modified process provide at least similar or more effective control of the product quality, safety, and efficacy compared to those of the original process. There is no need to be a statistician to take this course! If you have a working understanding of basic statistics this course will take you to the next level.

Attendees will learn the ins and outs of setting up formal comparability studies. Topics include an overview of regulatory requirements, statistical considerations for establishing statistical equivalence, various regression analyses and graphing techniques and understanding the importance use of various statistical intervals.

Click on the titles below to learn more about each session. When live sessions are available, sign up anytime and receive links to recordings of any individual sessions or all six sessions. Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course.

Each 60-minute session is just $339 per session or $2373 for all seven sessions! Great group discounts are available.

Session 1: Introduction to Comparability

Introduction to Comparability

  • Instructor: Kevin Brooks, MSc, PhD
  • Format: On-demand recording available now.
  • Content:
    ● What it is and what it is NOT
    ● General Considerations
    – Regulatory
    – Quality
    – Data

Session 2: Comparability: Testing of Means

Comparability: Testing of Means

  • Instructor: Kevin Brooks, MSc, PhD
  • Format: On-demand recording available now.
  • Content:
    ● A TOST to Statistical Equivalence

Session 3: Defining the Margins

Defining the Margins

  • Instructor: Kevin Brooks, MSc, PhD
  • Format: On-demand recording available now.
  • Content:
    ● Considered the most crucial step in equivalence testin
    – A wide margin increases the likelihood to establish/demonstrate equivalence, however, it can also invite criticism from regulatory agencies unless such a choice is fully justified.

Session 4: Comparability in 3-D

Comparability in 3-D

  • Instructor: Kevin Brooks, MSc, PhD
  • Format: On-demand recording available now.
  • Content:
    ● Passing–Bablok regression
    ● Deming regression, and
    ● Bland-Altman Analysis

Session 5: Introduction to Some Important Intervals

Introduction to Some Important Intervals

  • Instructor: Kevin Brooks, MSc, PhD
  • Format: On-demand recording available now.
  • Content:
    ● Tolerance Interval
    ● Prediction Interval
    ● Process Capability Interval

Session 6: Comparability by Variability

Comparability by Variability

  • Instructor: Kevin Brooks, MSc, PhD
  • Format: On-demand recording available now.
  • Content:
    ● Consider a prediction bound that exceeds the standard deviation of the test batch data based on reference batches
    ● Stability Evaluation
    – Historical introduction, guidance review

Session 7: Bringing it all Together/Summary

Bringing it all Together/Summary

  • Instructor: Kevin Brooks, MSc, PhD
  • Format: On-demand recording available now.
  • Content:
    ● Course Summary

COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant. For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.