Comparison of Analytical Results for Accuracy and Transfer

Participants will learn statistical fundamentals for data comparison, including simple comparison, significance, and equivalence testing, to understand practical consequences, study design, and acceptance criteria, minimizing failure risk.
  • Thursday
  • March
  • 19
  • 2026
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
IMG Joachim Ermer
Webinar Id: 62323
Live
Session
$119.00
Single Attendee
$249.00
Group Attendees
Recorded
Session
$159.00
Single Attendee
$359.00
Group Attendees
Combo
Live+Recorded
$249.00
Single Attendee
$549.00
Group Attendees

Overview:

Comparison of data is an important tool to evaluate the suitability of analytical procedures, for example in validation of accuracy, in analytical transfer, but also to assess the impact of changes in analytical procedures (“bridging studies” according to ICH Q14 "Analytical Procedure Development") and manufacturing processes. The new ICH Guideline Q2(R2) "Validation of Analytical Procedures" recommends the comparison of confidence or other statistical intervals (i.e. equivalence testing) with acceptance limits to validate accuracy.

Why you should Attend:

Participants will learn statistical fundamentals concerning comparison of data (simple comparison, significance and equivalence testing), in order to improve their understanding for the practical consequences, such as the impact of the number of data, the design of comparison studies, as well as appropriate acceptance criteria. Such understanding will help to minimize the risk of failure.

Areas Covered in the Session:

  • Simple comparison: Variability and difference between means
  • Statistical significance tests
  • Statistical equivalence tests
  • Sample size estimation and impact of the number of data - design of comparison studies
  • Appropriate establishment of acceptance criteria

Who Will Benefit:

  • Analysts
  • Lab Supervisors and Managers in Analytical Development
  • Quality Control, or Quality Assurance Responsible to Validate or Transfer Analytical Procedures, or to Design, Perform or Evaluate Comparison Studies

Speaker Profile

Dr. Joachim Ermer is a biochemist with 30 years of experience in pharmaceutical analytics, including development products at Hoechst AG, global responsibilities as Director of Analytical Processes and Technology at Aventis, and head of Quality Control and head of QC Lifecycle Management Frankfurt Chemistry at Sanofi. Since December 2020, he serves as consultant for topics of pharmaceutical analytics and Quality Control. Joachim Ermer is member of the USP Expert Committee “Measurement and Data Quality“, of the Ph.Eur. Working Group “Chromatographic Separation Techniques”, and Advisory Board member of the ECA Analytical Quality Control Group.

He authored more than 60 publications on analytical topics and contributed to the USP General Information Chapter <1220> as well as other Stimuli Articles. He is editor and author of the book “Method Validation in Pharmaceutical Analysis. A Guide to Best Practice” (Wiley-VCH, 2005, 2015, 2024).