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

A collaboration between:
Key2Compliance® and VALIDEIRE

Conference description

This two-day, intensive virtual 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 pre-recorded presentations and real-time interactive workshops complemented by real-time 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

Day 1
Moderator: Laurence O’Leary, ValidEire Aps

  • 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
    Ruijin Song (CPCI)
  • Plenary Q&A
  • Workshops (Parallell)
    • QRM on Cleaning Validation
      Ken Farrugia
    • Statistical Qualification of Visual Inspection to comply
      with EMA Q&A #7 & #8

      Andrew Walsh
    • Review of HBEL’s
      Andreas Flückiger

Day 2
Moderator: Pierre Devaux, Theraxel

    • 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. 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.

Who should attend

This course is intended for:

  • Team Leaders and Management within Quality Assurance and/or Production/Product Supply
  • Specialists, Professionals, and/or Project Managers responsible for change management, strategic operation, stakeholder management, training and/or global communication
  • Internal/External Lead Auditors
  • Team Leaders and Management within Regulatory Affairs and Research and Development should also attend
  • Risk management personnel, Compliance, and/or Health and Safety specialists

Conference model

We have created a conference model that accommodates the best experience for all attendees in the current global Covid-19 situation. We hope to facilitate for more attendees and the conference price also is reduced significantly to open up for a wider audience.

Presentations (Pre-recorded Sessions)

All presentations will be pre-recorded in September 2020 as speakers’ local time zones will not be optimal for presenting with local times in central European time (CET) when the event is hosted. These will however be broadcast at the times displayed in the table and available prior and after the conference to view at no further cost.

Plenary Q&A (Live Sessions)

The speakers will be present in real time and available to answer questions either relayed beforehand by mail or live at the plenary Q&A. These will be broadcast at the times displayed in the table and be available after the conference to view at no further cost.

Workshops (Live Sessions)

The workshops also will be in real-time and dual communication between the facilitator and attendees will be possible either through a chat function or via microphone managed by the moderator. These will be broadcast at the times displayed in the table and be available after the conference at no further cost.


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Date & Time
Public course planned spring 2021

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In-House Training

This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.

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Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.



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