Science, Risk and Statistics-based Cleaning Process Development and Validation

Conference co-organized by Key2Compliance® and ValidEire ApS

Sponsored by
Novatek International


Conference description

This two-day, intensive conference brings together the industry leaders on Science and Risk- and Statistics-based Cleaning Process Development and Validation. The conference will go beyond presentations on best practice and consists of workshops complemented with plenary Q&As. Attendees will therefore gain a deeper understanding of the new ASTM E3106 Standard, PDA TR 29 revision, Annex 1, HBELs, new draft and use of statistics in cleaning validation, as well as risk evaluation and data integrity in cleaning validation – among other things.

Conference outline (Download program and speaker presentations here →)

Day 1
Moderator: Lars-Eric Ellow, Key2Compliance AB

  • Introduction to ASTM E3106 “Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation” and upcoming Standards
    Andrew Walsh (CPCI)
  • Annex 1 Revision
    Pierre Devaux (Theraxel)
  • ASTM “Standard Guide for the Derivation of Health Based Exposure Limits (HBEL’s)” for Drugs and Devices
    Andreas Flückiger
  • Sustainable Quality Assurance through the Application of Quality Risk Management in Cleaning
    Ken Farrugia (Natrix Sciences Ltd.)
  • Analytical Development: A Useful Support for Cleaning Control and Validation
    S. Janvier (Pierre Fabre Group )
  • Application of Statistics to Cleaning Process Development
    Andrew Walsh
  • Plenary Q&A
  • Workshops (Parallell)
    • QRM on Cleaning Validation
      Ken Farrugia
    • Visual Inspection Qualification
      Andrew Walsh
    • Review of HBEL’s
      Andreas Flückiger

Day 2
Moderator: Lars-Eric Ellow, Key2Compliance AB

  • Use of Statistics for Cleaning
    Igor Gorsky (Valsource)
  • Statistical Determination of Swab Recovery Factors in Coupon Studies
    Ioanna-Maria Gerostathi
  • Implement a Risk-Based, Data Integrity Compliant Cleaning Validation Management System
    Susan Cleary (Novatek)
  • Cleaning Process Risk Evaluation — A Quantitative Framework
    Mohammad Ovais
  • Lean Six Sigma Case Study Using Total Organic Carbon Analysis
    Andrew Walsh (CPCI)
  • Plenary Q&A
  • Workshops (Parallell)
    • Application of Statistics to Cleaning Processes
      Mohammad Ovais
    • Recovery method with Swabs
      Ioanna-Maria Gerostathi

Conference objectives

The objective of this conference is to provide participants with practical knowledge and understanding of regulatory requirements and techniques that can be put to use in their own cleaning process development and validation strategy. The presenters will focus on the newest information available and will cover a wide range of subjects relevant to cleaning process development and validation.

Who should attend

The conference is primarily relevant for R&D staff, Leaders, Supporters, Validation teams in production and Quality Assurance seeking the latest knowledge about risk- and statistics-based cleaning validation, as well as for engineering companies wanting to learn more about the viewpoint of the pharmaceutical industry and exchanging experience.

Hybrid event

The event will be streamed live so both attendees and speakers can participate globally.

Plenary Q&A

The speakers will be available to answer questions either relayed beforehand by mail or live at the plenary Q&A.


The workshops also will be dual communication between the facilitator and attendees.


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Date & Time
April 28, 2022
- April 29, 2022
Day 1: 08:50-17:40 CET Day 2: 08:50-16:40 CET
LocationCopenhagen, Denmark, Online
VenueDGI Byen

 1 495

No. persons
Early bird price above until March 15th 2022 / 3 persons or more 15% if registered and invoiced together for the same course.

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