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WEBINAR: USP 1788 Revision Overview

On Demand

USP <1788> 2022 Revision Overview

In May 2021 a revision to USP<1788> Methods for Determination of Subvisible Particulate Matter was issued. It replaced the existing guidance contained in previous versions of USP <1788> (2011), which covered only the testing requirements for Optical Light Obscuration testing and Microscope testing – carry over from previous USP <788>.

This webinar looks at the holistic view of finished product contaminants, and how they should be investigated.

USP<1788> provides guidance to better describe the process around understanding why the current limits and methods prescribed in <788> are applied.


Webinar Presented By:
Mark Hallworth
Global Pharma and Sr. GMP Advisor, Life Sciences Division

Mark Hallworth is the Life Sciences Global Manager and Senior GMP Advisor at Particle Measuring Systems. Over Mark’s long career in contamination control, he has managed the design, installation, and validation of over 200 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE, and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field. Most recently, Mark was a member of the international ISO 14644-21 technical committee responsible for reviewing and revising the standard. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.

Richard Duskey
Software/Systems and select Liquids Product Manager - Electronics, Particle Measuring System

Mr. Duskey is currently a Software/Systems and  select Liquids Product Manager in the Electronics division with Particle Measuring Systems. Rick transitioned from his technical role in the military 8 years ago to a Service Technician position at PMS, working on a wide array of products. He has worn many hats at PMS and successfully covered positions in Service, Technical Support, Sales support,  Metrology, Life Science and Electronics Product Management . In 2019, Rick joined PMS’s team of experts presenting Particle College educational courses. He is a recent graduate of the University of Colorado Boulder Leeds School of Business Executive MBA program. In his spare time, he is the State of Colorado Director of the Veteran Golf Association and enjoys spending time outdoors and with his family.