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Webinar

 

Review of Annex 1 2022: Environmental Monitoring Changes

EU GMP Annex 1 has been released after much anticipation, and new revisions tend to cause confusion. PMS has put two of our experts to the task of explaining the environmental monitoring requirements, providing practical solutions, and answering your questions.

Pharmaceutical manufacturing is performed in controlled environments to reduce contamination, and changes recently announced by Annex 1 focus more on strategic control than on measurement of quality. This Quality by Design (QbD) ideal interconnects different disciplines to ensure that clean spaces are maintained according to their Classifications and that environmental monitoring procedures are based on risk to the product.

This free webinar will identify the aspects of Annex 1 that have, and have not, changed from previous versions, and how to meet the requirements. This webinar will cover:

  • Revised Annex 1 document layout for environments
  • Changes for cleanroom classification
  • Changes for cleanroom monitoring

Meet the speakers:

Mark Hallworth is the Pharmaceutical Manager for Particle Measuring Systems. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control.” He is part of ISO 14644 working group 15, and currently lectures for the PDA, ISPE, and other international societies.

David Crance is the Life Sciences and OEM Sales Manager for PMS. With over 35 years of experience in contamination control and systems, he has been involved in the design and implementation of more than 700 environmental monitoring systems. He has been an instructor at the Parental Drug Association (PDA) for 18 years in Bethesda, Maryland.

Complete this form to access the webinar:

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T. +1 303-443-7100
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Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • BioCapt® Certificate of Analysis (CofA)
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Meet USP<788> Particulate Matter in Injections
  • Parts Cleanliness Testing
  • Annex 1 Environmental Monitoring Solutions for Your Contamination Control
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • PMS™ Knowledge Center
  • Particle College
  • Software / Data Management
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility, Sustainability, Health & Safety
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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