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
Mark Hallworth
Life Sciences Global Manager and Sr. GMP Scientist, Particle Measuring Systems

Mark Hallworth is the Life Sciences Global Manager and Senior GMP Scientist 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. 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 200x200
Richard Duskey
Associate Product Manager - Life Sciences, Particle Measuring System

Rick is currently a remote sensors and liquid products Associate Product Manager in the Life Science division with Particle Measuring Systems. Rick transitioned from his technical role in the military seven 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 and Metrology. In 2019, Rick joined PMS’s team of experts presenting Particle College educational courses. He is currently enrolled with the University of Colorado Boulder Leeds School of Business Executive MBA program. In his spare time, he enjoys spending time outdoors and with his family.

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