Optimize Cleaning Processes to Maximize Production Time
Critical Cleaning Process Parameter Identification and Cleaning Process Development

A Free FDAnews Webinar • Sponsored by Ecolab Life Sciences
Thursday, May 20, 2021 • 12:00 PM - 1:00 PM EDT

Basing your cleaning processes on past use or available cleaning chemicals may be an ineffective use of production time and money — not to mention you might also be risking Form 483s or warning letters.

If you’re still performing repeated cleaning and retesting until your manufacturing facilities achieve acceptable residue results, this free webinar is a must.

It’s now vital to use a risk-based approach to identify cleaning process parameters and intentionally develop the resulting processes.

Cleaning process development is coming up more and more when addressing ongoing cleaning verification processes, not just at the beginning of cleaning validation projects. But conduct proper process development and you can easily answer which cleaning process parameters must be tracked.

Thomas Altmann, global technical manager at Ecolab, will explain how cleaning processes can be evaluated using bench scale studies, provide guidelines for how to identify critical cleaning parameters and show you how to perfect the development of your processes. He’ll share how to develop and optimize cleaning processes to ensure current good manufacturing practices (cGMPs).

Free webinar takeaways:

  • How to improve or optimize cleaning processes using experiments (from ASTM E3106-18, the “Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation”)
  • How to perform an assessment on all cleaning processes to determine the variable factors that influence cleaning effectiveness and performance (from the European Commission’s EU Guidelines for Good Manufacturing Practice Annex 15)
  • How laboratory bench scale studies can be used to identify an effective cleaning process
  • How to evaluate lab trials and translate resulting data into manufacturing instructions and SOPs

Easily optimize your cleaning processes, reduce cleaning time and increase production/manufacturing efficiency with this free webinar. Join us by registering today for this free webinar.

Who Will Benefit

  • Data Management Professionals
  • Informatics Professionals
  • Quality Professionals (Quality Assurance, Quality Control, etc.)
  • Clinical Professionals
  • Regulatory Professionals
  • Manufacturing Professionals
  • IT Professionals
  • Medical Professionals (at Biotechs and Start-ups)
  • Pharmacodynamics Professionals, Pharmacovigilance Professionals, Pharmacokinetics Professionals, etc.
  • Analytical or Analysis Professionals, Data Management Professionals and Biostatistics Directors or Vice Presidents
  • C-Suite Professionals (smaller companies)
  • Compliance/Governance Professionals

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Meet Your Presenter

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Thomas Altmann

Global Technical Manager
Ecolab

Thomas Altmann, global technical manager at Ecolab, has 22 years of experience consulting for the pharmaceutical and biotechnology industries, as well as API production and the cosmetic/personal care industry, with all questions related to cleaning, validation and disinfecting of product-contact surfaces. He also oversees environmental hygiene of production periphery in the a.m. industries. He was a member of the working group that wrote the ASTM E3106-18 “Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation” published in March 2018. Mr. Altmann is also an active member of the Parenteral Drug Association (PDA).