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Annex 1 2022 is really Annex 1 2008: Learn how they align.

Learn how Annex 1 2022 is not ultimately different than Annex 1 2008. The language has changed to clarify and better define the expectations; however, the underlying intent is the same.

Industry expert Mark Hallworth will show side by side, section by section, comparisons to explain the changes.

In the end, we will discuss what is truly needed to meet EU GMP Annex 1 (hint: a good Environmental monitoring system from a knowledgeable company).

Key takeaways

  • Get a side-by-side comparison by section of Annex 1 2008 vs. 2022 to see the underlying commonalities
  • Understand what is new in 2022 and how it relates to the 2008 expectations
  • Learn how to meet EU GMP Annex 1

March 8- Registration.

Time: 8:00 a.m. European Standard Time

 

 

 

 

Note: All registrants will receive a recording.

 

  • Presenter

    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”.

  • Presenter

    David Crance

    Life Sciences and OEM Sales Manager, Particle Measuring Systems

    David Crance is the Life Sciences and OEM Sales Manager for Particle Measuring Systems and has worked in various roles in the Life Sciences business sector for over 35 years. He has lectured for pharmaceutical societies and organizations throughout the USA and APAC on environmental monitoring systems and their cGMP regulations. He is currently an instructor at the Parenteral Drug Association (PDA) headquarters in Bethesda, Maryland, USA, where he has been teaching contamination and aseptic control for the past 18 years. David has been involved in the design and implementation of over 700 environmental monitoring systems around the world. In his role as Life Sciences Sales Manager, David works with leading engineering firms and manufacturers in the design and effective implementation of environmental monitoring systems.