Annex 1 Environmental Monitoring Common Questions and Answers

July 12th, 2023 • Available On Demand

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July 13th, 2023 • Available On Demand

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Overview



The newly published Annex 1 comes into effect this August 2023, Particle Measuring Systems have been involved in discussions with industry and regulatory focused teams defining how best to address the new elements of environmental monitoring to meet these new requirements.

Environmental Monitoring expert Mark Hallworth shares questions he frequently receives, along with practical answers to help you meet your EM needs.

This webinar covers:

  1. Certification vs monitoring
  2. Tubing length and particle losses
  3. Appropriate alert and action limits
  4. Continuous microbial sampling using RMM and traditional techniques

Who should attend:

  • Environmental Monitoring team members
  • Quality Assurance
  • Quality Control
  • Production Team Supervisors

Speakers:


Mark Hallworth
GMP Scientific Advisor
Particle Measuring Systems


Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review