Europe, Middle East, Africa

Date: April 25
Time: 2:00 PM CET (UTC +1)

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The European Commission very recently released their EU GMP Annex 1: 2017 draft for review and comment. Our experts have reviewed this document carefully and are ready to share their insights with you. 

Attend this webinar to:

  • Get an expert review of Annex 1
  • Get insights and feedback from experts on the Annex 1 draft
  • Submit your comments and feedback (we will compile for the commission)
  • Learn what the updated Annex 1 might mean to you 

What's Included?

  • Certificate of Attendance
  • Summary of Experts' Comments
  • Recorded Webinar

Presenter

Gilberto Dalmaso

PhD - Senior Advisor and Pharma Customer Advisory Team Manager

Gilberto has over 25 years’ experience in pharmaceutical microbiology and sterility assurance. Today he is a reporter to numerous symposia on the microbiology and Pharma in Europe and United States. Dr. Dalmaso is the Global Consultant and Subject Matters Experts Team Manager for Particle Measuring Systems. In this role and with his team of subject matters experts, he collaborates and consults with pharmaceutical companies to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes.

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

Life Science Division, 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 in 2015.

Save My Seat

Date: May 23, 2018
Time: 11 AM - 2 PM EDT (UTC-4)

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Get practical insights helping you to create an auditable risk assessment. This three hour online workshop, taught by a professional risk assessment advisor, teaches you basic Risk Assessment principles and processes. An example of a risk assessment of a new clean room with a filling line will be used, showing how to determine sample point locations.

There will be several opportunities to submit questions directly to the risk assessment advisor regarding your application.

Attend this online workshop to:

- Gain a working knowledge of the FMEA process as it is applied to processes and product
- Identify potential failure modes as they relate to risks to product contamination of sterile products
- Use a systematic approach to document rationale for selection of risk levels

Attendees will receive a Certificate of Training for FMEA Risk Assessment Workshop.

Global Pharma GMP Advisor

Lisa Lawson

Global Pharma GMP Advisor

Lisa G. Lawson has over 25 years’ experience in supporting large and small pharmaceutical companies in contamination control, including cleaning and disinfection strategies, aseptic manufacturing and use of risk-based approaches to microbiological quality challenges. She spent 16 years working for Amgen in microbial and mammalian cell culture manufacturing support and helped gain commercial FDA and internatonal regulatory approval of the EPO/NESP manufacturing facility in Longmont, CO.