+41 71 987 01 01

Particle Measuring Systems

On-Demand Webinar: EU GMP Annex 1 Review, Insights, and Feedback

On December 20th, 2017,  the draft for a Revision of  EU GMP ANNEX 1 (“Manufacture of Sterile Medicinal Products”) was published.

This on demand webinar provides a summary of the new aspects of environmental monitoring in sterile manufacturing and its potential implications to the Pharmaceutical industry.

The consultation document for the new Annex 1 revision provides insight into upcoming regulatory trends. In terms of environmental monitoring content, there is significant emphasis placed on manufacturers basing their decisions on scientifically sound and historical data while applying a risk-based approach.

From a microbiology and particle contamination perspective, this document may push modern, relevant  and scientifically sound monitoring methods into the pharmaceutical world, in addition to a reasonable trending approach to data analysis.

Watch this webinar to:

  • Get Annex 1 reviews from various industry experts
  • Find out what change have been made and the impacts they will have
  • Get insights and feedback from experts on the Annex 1 draft
  • Learn what the updated Annex 1 might mean to your cleanroom manufacturing
  • Answers to common questions

Complete the form at the right to access this webinar.

Are you prepared for the new EU GMP Annex 1? Particle Measuring Systems can help you with:

  • 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

    Sr Daniele Pandolfi

    美国粒子监测系统公司 软件/系统/服务全球产品线经理

    Daniele Pandolfi是美国粒子监测系统公司，软件/系统/服务全球产品线经理。他拥有超过11年的粒子计数器和洁净室污染控制经验，专注于建立和维持强大的客户关系。他帮助许多洁净室用户解决了他们的cGMP问题。

  • Presenter

    Gilberto Dalmaso

    Global Life Science Scientific Officer

    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 Life Science Scientific Officer for Particle Measuring Systems, serves on the European PDA Committee, is a reporter to numerous symposia on the microbiology and Pharma in Europe, Asia and United States, and is an ISO 9001 and HACCP quality system auditor.