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Webinar

Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for ANNEX 1

Contamination Control Strategy (CCS) for viable monitoring per Annex 1

While the new Annex 1 is still in draft stage, the drafts tell us clearly where the committee is heading as far as priorities and gives us guidelines that we can apply now to your Contamination Control Strategy (CCS) to be ready for the final Annex 1 update release. The New Annex 1 has some critical changes that are important to understand and start applying. While the drafts cover many areas of environmental monitoring in-depth, this webinar by Particle Measuring Systems’ (PMS) experts focuses on the Viable/Microbial Air Monitoring aspects including:

  • Designing an effective Contamination Control Strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles.
  • Newest Annex 1 Single Use Requirements relevant solutions
  • Microbial Plate Incubation and Pharmaceutical Risk Assessments
  • Importance of Continuous Viable Air Monitoring
  • How the underlying need of a Quality Risk Management (QRM) approach, along with Risk Assessments based on science are to be the fundamental principles driving decisions to protect product quality
  • When, Where, and How to do Environmental Monitoring
  • Changes in Viable Monitoring Requirements
  • Solutions to meet these requirements
  • Concepts regarding the requirements for a Pharmaceutical Risk Assessment to set appropriate Microbial Plate Conditions 
  • Much more!

Particle Measuring Systems (PMS) offer this Contamination Control Strategy (CCS) webinar in two time zones to meet your needs. Choose one of the times below to start your registration:

  • 10:00 am CET (Europe timezone)/ 4pm (China timezone)
  • 11 am ET (NYC-USA)/ 5pm (Europe timezone)

There are opportunities to submit questions during registration, during the webinar, or after the webinar.

  • Presenter

    Dr. Frank Panofen

    PhD, Life Science Division, Product Line Manager Microbials, Particle Measuring Systems

    Dr. Panofen has a Diploma in Chemistry from the University of Bielefeld and a PhD in molecular and cell biology from the University of Osnabrück. He has expansive experience in the field of applied pharmaceutical microbiology and serves as the Sterility Assurance/Microbiology Product Line Manager at Particle Measuring Systems. Frank has been an invited speaker at international conferences including ECA and PDA, with a strong regulatory background in pharmaceuticals. He is a certified Microbiological Laboratory Manager from ECA.

  • Presenter

    Dra. Giulia Artalli

    Gerente Global de Linha de Produtos, Particle Measuring Systems

    Dra. Giulia Artalli é formada em Biologia pela Universidade de Milão, com mais de 20 anos de experiência em Microbiologia, especialmente para aplicações farmacêuticas.
    Dra. Giulia Artalli cobriu várias funções para adquirir conhecimento sobre vários tópicos que são úteis para ajudar os clientes com suas necessidades. Ela é  Gerente Global de linha de produtos da Particle Measuring Systems para a Linha de Produtos de Microbiologia.

  • Presenter

    Paola Lazzeri

    EMEA Field Application Specialist Sterility Assurance/Microbiology, Particle Measuring Systems

    Paola has extensive professional experience over 14+ years supporting pharmaceutical companies in the application of regulatory requirements, with a specific focus on microbiological contamination control. She maintains this expertise through constant dialogue with Quality Officers, Production and Financial teams in the various industries she works with. She actively collaborates with the PMS Advisory Team on decontamination strategy using a Quality Risk Management approach and assists Pharma companies with the validation of sanitizing and decontaminating agents. Paola also regularly writes technical articles and participates as a speaker at national and international Pharma conferences.

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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

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

Service & Support

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  • 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:

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