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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

    Daniele Pandolfi

    Global Product Line Manager, Aerosol, Particle Measuring Systems

    Daniele Pandolfi is the Global Product Line Manager, Aerosol in Particle Measuring Systems’ Life Science Division. He has over eleven years’ experience in particle counter instrumentation and cleanroom contamination control, focusing on strong customer relationships. He has helped many cleanroom users solve their cGMP issues. Mr. Pandolfi has been responsible for the EMEA Service Department, and a member of the Global Life Science organization since 2015.

  • 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.