Lifecycle Approach to Analytical Method Transfer

This webinar teaches participants how to use knowledge like risk assessment, system suitability tests, and control charts to design efficient transfer strategies, reducing effort for the sending laboratory.
  • Wednesday
  • August
  • 20
  • 2025
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
IMG Joachim Ermer
Webinar Id: 61274
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:

The transfer of analytical procedures is a frequent - and often time-consuming - activity during the lifecycle of a drug substance or drug product. Thus, it is always in the focus of audits and inspections. 

Applying a systematic lifecycle and Quality-by-Design (QbD) approach to analytical method development according to ICH Q14 and USP <1220>, the fundamental facilitation of transfer consists in an enhanced understanding of the analytical procedure, resulting in a tailored Analytical Procedure Control Strategy and an improved robustness. However, the lifecycle approach can and should be directly used to facilitate transfer and improve its efficiency as well, for example using monitoring and control charts to justify a “lean” transfer study, or even a waiver of additional comparison studies.

Why you should Attend:

Participants of this webinar will learn how to use enhanced knowledge and understanding (e.g. risk assessment, system suitability tests, sample suitability assessments, control charts) to design and justify efficient transfer strategies. Such strategies may include the receiving laboratory only, thus reducing the effort for the sending laboratory considerably.

Areas Covered in the Session:

  • The issue of comparative studies
  • USP <1220> Analytical procedure life cycle, ICH Q14
  • Advanced lifecycle transfer strategy (Analytical Procedure Control Strategy, control samples & charts)
  • "Lean" transfer design supported by (continuation of) control charts
  • Detection of small systematic shifts

Who Will Benefit:

  • Analysts
  • Lab Supervisors and Managers in Analytical Development
  • Quality Control, or Quality Assurance who want to Improve the Efficiency of their Analytical Method Transfers by using an Enhanced Lifecycle Approach or who are Interested to start with Corresponding Preparations

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).