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  • New upcoming changes of the EU GMP Annex 1

    How to face the new challenges?

    (Focus on clean rooms & pharmaceutical water/gas systems)

    On 20th December 2017, the European Commission published a revised draft of Annex 1 "Manufacture of Sterile Medicinal Products" in connection with the EU GMP Guideline. The revised Annex 1 is a completely new document which will impact and challenge the current procedure for managing and qualifying clean rooms i.e. controlled environments, in addition to water- and /gas GMP systems, via introduction of a risk based approach at all levels.The Webinar will focus on what has been changed in Annex 1 and how to deal with such changes. There will also be specific topics focused on clean rooms and pharmaceutical water/gas systems. Eurofins BPT´s technical expert will discuss the rationale behind the new Annex 1, and go through “real life” examples and strategies to deal with the new changes and challenges.

    The main topics for the webinar:

  • Comparison: Old vs the New Annex 1. The rationale behind the changes.

  • Quality Risk Management and how this new umbrella is now an expectation.

  • What´s new for clean-rooms i.e. controlled environments, management? Strategies and related good practices under the risk based umbrella.

  • What´s new for the management of water and gas systems? Strategies and related good practices under the risk based umbrella.

  • Roundup of strategies: there are several strategies that can be implemented to cope with the modification of the annex 1, I´ll be discussing PROs and CONs of each one.

    Who will benefit from attending the Webinar:

       Changes of the new Annex 1 (EU GMP) is a shared responsibility between multiple functions in an  organization,   including (not limited to): 

Regulatory Affairs    Quality Management  Research and Development 
Quality Control      Outsourcing Managers    Production Manager
Process analysts   Process support    Utilities Responsible
Quality auditors    

                                                                  

Eurofins BioPharma Product Testing (Eurofins BPT) Denmark offers an online webinar on the 22th May 2018 - Sign up!

Webinar the 22th May

14.00 – 14.15

Eurofins BioPharma Product Testing Denmark A/S

Speaker: Nadja Sun, Sales & Business Development Teamleader

14.15 – 15.15

Changes of the new Annex 1 (EU GMP): Focus on clean rooms, pharmaceutical water/gas systems

Speaker: Pablo Moreno, Process Control and Validation Manager

Mr. Pablo Moreno has a scientific background in Chemical Engineering, and have been the acting business unit manager for Process Control and Validations at Eurofins Biopharma Product Testing Denmark since March 2016, where his primary responsibilities is to develop tailored analytical solutions and services for the Pharmaceutical industry in the Nordic countries. Pablo have 11 years’ experience and prior to working for Eurofins BPT Denmark he was working as a business unit manager for process control and validation in Italy with a staff of 12 employees since 2007, which have ensured him an in-depth knowledge and problem solving mindset in connection analytical testing, trending and validation services of clean rooms and controlled environments. In addition Pablo has been an active member of ISPE since 2013.  

15.15 – 15.30

Time for questions

Eurofins will provide the following to all attendees: Webinar handout Material & Attendance Certificate