Annex 1 2022: how does it align with Annex 1 2008?
Watch this webinar to learn about the commonalities between Annex 1 2022 and the 2008 version. Both have the same requirements, but 2022 has added better defining language. Get side by side comparisons.
About this webinar
Learn how Annex 1 2022 is not ultimately different from 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 between Annex 1 2022 and the previous version. He will also discuss a variety of solutions.
In the end, we will discuss what is truly needed to meet EU GMP Annex 1, including a good environmental monitoring system.
Key takeaways
- Get a side-by-side comparison by section of Annex 1 2008 versus 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.
Our speakers
Mark Hallworth, Life Sciences GMP adviser, Particle Measuring Systems
Mark is the Life Sciences Strategic Senior GMP Scientist. Mark has managed the design, installation, and validation of over 200 environmental monitoring system projects worldwide. 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.
John Huber, Life Science Sales Manager, Particle Measuring Systems
Mr. Jon Huber is the Life Sciences Regional Sales Manager in the southeastern US for Particle Measuring Systems. He been in the Pharmaceutical industry for over 20 years in both R&D and manufacturing roles. In his role at PMS, Mr. Huber works with pharmaceutical and biotech manufacturers, compounding pharmacies, and medical device companies in the design of environmental monitoring systems and sampling protocols.
Mr. Huber has lectured for pharmaceutical societies and organizations throughout the USA on EM systems and cGMP regulations. He is currently an instructor at the Parenteral Drug Association (PDA) in Bethesda, MD, the Aseptic Training Institute (ATI) in Clayton, NC and the UTHSC Plough Center in Memphis, TN.
