• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

+41 71 987 01 01

  • Youtube
  • Linkedin
  • English / CH
    • 中文
    • 台灣
    • Singapore
    • Denmark
    • English
    • Français
    • Français / CH
    • Deutsch
    • Deutsch / CH
    • Deutsch / AT
    • Italiano
    • 日本語
    • 한국어
    • Português, Brazil
    • Español
Newsletter

Search

Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Products
    • Air
    • Liquids
    • Microbial Samplers
    • Compressed Gases
    • Molecular
    • Software / Data Management
  • CAS Clean Air Services
    • Cleanroom Measurement Services
      • Smoke Studies
    • Thermal Validation
  • Education
    • PMS™ Knowledge Center
      • Particle Counting Education
      • Beginner Guide to Particle Counting
      • Contamination Monitoring Videos
      • Webinars – Archived
    • Blog
  • Applications
    • Industries
      • Hospital Regulatory Compliance Services
      • Pharma
      • Cosmetics & Personal Care
      • Aerospace
      • Photonics & Optics
      • Semi
    • ISO 14644
    • ISO 21501-4
    • USP 797
    • USP 788
    • Parts Cleanliness Testing
    • Annex 1
    • 21CFR 11
  • Service and Support
    • Product Calibration & Service
      • Balometers
      • Anemometers
    • Project Management
    • Hardware & Software Support
    • Customer Service
  • About Us
    • Contact Particle Measuring Systems
    • Why Outsource With CAS
    • Why Choose US
    • Credibility & Registrations
    • Careers
    • Executive Team
    • Press Releases
    • Corporate Responsibility, Sustainability, Health & Safety
    • COBE
    • About Spectris
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance
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.

Products

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

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Service & Support

Knowledge Center

  • COBE
  • Contact Particle Measuring Systems

About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems EN-CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

Products

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

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 21501-4
  • USP 788
  • Parts Cleanliness Testing

Service & Support

Education and Training

  • PMS™ Knowledge Center

About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems- EN/CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

  • Website Disclaimer
  • Third Party Privacy Notice
  • Privacy Policy
  • Legal

© Copyright 2023 - Particle Measuring Systems is a Spectris company