Establishment of a Science-Based Replication Strategy for the Reportable Result

This webinar discusses optimizing precision in repeat injections and preparations of samples and reference standards, discussing factors affecting variability optimization, practical orientation, and recommendations for Quality-by-Design replication strategies, and potential FDA-Guidance conflicts.
  • Thursday
  • November
  • 06
  • 2025
10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
IMG Joachim Ermer
Webinar Id: 61696
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:

An important aspect of the analytical lifecycle management is a systematic (quality-by-design) method development to gain an enhanced understanding of the procedure’s performance, as described in the new ICH Q14 Guideline “Analytical Procedure Development” (2023). The reportable result “as generated by the analytical procedure after calculation or processing and applying the described sample replication” is an important aspect of the Analytical Procedure Control Strategy, which allows an optimization of the precision by averaging.

Why you should Attend:

Repeated injections and preparations of sample and reference standard are often generically defined, or based on “tradition”. This webinar provides the scientific and statistical background to optimize the precision of the reportable result to ensure its fitness for purpose. Impacting factors regarding the optimization of variability by averaging will be discussed, providing practical orientation and recommendations for a Quality-by-Design-based replication strategy. Further, potential conflicts and solutions with regard to the current FDA-Guidance on OOS results are discussed

Areas Covered in the Session:

  • Statistical background - precision of the mean (standard error)
  • Application to multiple precision levels (USP <1220>) & bioassays (USP <1033>)
  • What is the practical effect of increasing the number of determinations (dependence on relative variance contributions)
  • Prerequisites for an appropriate establishment of the replication strategy (reliability of the variance contributions from precision studies, check of "normal" variability)
  • Consideration of regulatory expectations- FDA (CDER) "averaging issue"

Who Will Benefit:

  • Analysts, Lab Supervisors and Managers in Analytical Development, Quality Control, Quality Assurance, or Regulatory Functions Responsible to Develop, Optimize, Establish, Validate or Evaluate Analytical Procedures

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. From 2010 till 2020, he was also responsible for the central reference standard group and Global Reference Standard Coordinator of 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).