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Webinars

Abstract
Quality by Design (QbD) is a well-known concept in the pharmaceutical industry to increase the overall quality of pharmaceutical drugs and increase patient´s safety. Controlling the quality of air inside an environmental monitoring program is a vital aspect of managing the risk towards the patient.

This webinar will give you an insight into how QbD can be applied to microbiological monitoring using most recent advances in technologies, including single-use. We will introduce and discuss the concept of continuous viable air sampling following the guiding principles that are well known from the particle monitoring aspect.

Speakers
Gilberto Dalmaso, PhD
Dr. Gilberto Dalmaso has over 25 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK).  In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Global Aseptic Processes Development Manager for Particle Measuring Systems, serves on the European PDA Committee, is a reporter to numerous symposia on the microbiology and Pharma in Europe and United States, and is an ISO 9001 and HACCP quality system auditor.

Frank Panofen, PhD
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 s certified Microbiological Laboratory Manager from ECA.

Date / Time
Two dates and times are offered to reach our global clients:

  • October 13, 10:00 am Colorado MT / GMT – 0600  

    Register

  • October 20, 10:00 am Rome / CEST / GMT +0200

    Register

Archived On Demand Webinars

  • Identifying the best rapid microbial monitoring solution for your critical & ISO 5/ Grade A surfaces

    Managers need the assurance that the surfaces in their facilities are aseptic. Gaining that knowledge in a fast and accurate way that also provides results for all surfaces, even and uneven, is a challenge.

    learn more or download now

  • Identifying a safe and reliable microbiological air sampling solution for ISO 5 environments

    Personnel pose the greatest risk of false positives in aseptic processing. The BioCapt®Single-Use eliminates false positives and costly investigations by preventing direct operator contact with the media plate.

    Presenters: Daniele Pandolfi

    learn more or download now

  • Case Study: Developing an Isolator Filling Line Using a Quality Risk Management Approach 3/14/2019

    learn more or download now

  • The New EU GMP Annex 1 Revision 2017: Review, Insights and Feedback

    Download this webinar to get a first look and review of the Annex 1 draft, released for comments. Our experts will be providing their comments and will want to hear your thoughts on this new version.

    learn more or download now

  • Sterility Assurance Applied to Stem Cell Therapies 6/12/2019

    Presenters: Gilberto Dalmaso, PhD

    learn more or download now

  • Achieve a Safe Bioburden Level by Applying Alcohol Cleaning & Disinfection Best Practices 4/18/2019

    learn more or download now

  • ISO 14644-1:2015 Revisions Summary

    Learn about ISO 14644-1:2015 and how it affects your clean environment monitoring. The recent revision of ISO 14644-1 introduced several changes for cleanroom classification and monitoring guidelines. Join us for a review of the changes and how they affect your environment monitoring.

    learn more or download now

  • From Paper to Paperless-Tackling the 21CFR11 Challenge 6/26/2019

    Presenters: Daniele Pandolfi / Maurizio Della Pietra

    learn more or download now

  • Leveraging Data Management for Root Cause Identification in Critical Environments 3/29/2019

    Presenters: Maurizio Della Pietra / Anna Campanella

    learn more or download now

  • Increasing Productivity by Leveraging Single Use Technology in Air Monitoring 4/30/2019

    learn more or download now

  • Complying with USP 729 / 788-1788 Regulatory Requirements 5/9/2019

    Presenters: Daniele Pandolfi

    learn more or download now

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Particle Measuring Systems

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Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Certificates of Analysis
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Industrial Manufacturing

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  • ISO 21501-4
  • USP 788
  • Parts Cleanliness Testing
  • EU GMP Annex 1

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  • Customer Service

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Particle Measuring Systems

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T. +45 7070 2855
[email protected]

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