Webinar Series Annex 1 – Barrier Systems, Developments for RABS and Isolators

Webinar Series Annex 1 – Barrier Systems, Developments for RABS and Isolators

Course No 18115

Important: Deadline is 12 noon on 5 August 2020

You will find all webinars of this series in this overview

Costs

ECA-Member: EUR 199,--
Non ECA Member: EUR 249,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Friedrich Haefele, form. Boehringer Ingelheim Pharma, Germany

Background

With the current revision of the specifications for aseptic processing and the requirement for clear strategies to minimise the risk of contamination by microbial and cellular impurities (e.g. pyrogens, endotoxins) and by visible and non-visible particles, there is a new focus on barrier systems such as RABS and isolators. Such strategies should be considered as a life cycle approach and alternative approaches instead of RABS and isolators should be rationally justified. This development is also reflected in the current draft of Annex 1.

Target Group

This webinar is aimed at employees from Production, Engineering, Quality assurance,  Quality Control,  and Authorities who are involved in the preparation, implementation, operation and monitoring of Aseptic Processing facilities on the background of the revised Annex 1.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

During the webinar you will have the opportunity to
  • understand the regulatory requirements (EMA, FDA) for
  • aseptic processing equipment,
  • compare the different approaches of conventional cleanroom, RABS and isolator designs and understand their specific advantages and disadvantages (design, qualification, monitoring, cleaning, disinfection),
  • learn benchmark practices between the participants.
In addition, the following topics will be covered during this webinar:
  • The differences and similarities between other regulatory requirements and the recent revision of Annex 1 
  • The operational difficulties and practical solutions of component and product transfer in RABS and isolators and how they are considered in monitoring and aseptic process simulation programs.
  • The different practices in different industries.

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