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ISPE D/A/CH Workshop: New European Pharmacopoeia Water for Injection Monograph – what will the WFI system of the future look like?

July 5, 2017@12:00 am

The ISPE D/A/CH Working Group on Pharmaceutical Water and Steam Systems invites you to a workshop, a technical discussion.

The theme:
“New European Pharmacopoeia Water for Injection (WFI) Monograph – what will the WFI system of the future look like?”

The demand for a guideline on how to handle the brand new monograph
– “Water for Injections (WFI) monograph (0169).”
and the EMA Q&A document
– “Questions and answers on production of WFI by non-distillation methods.
– reverse osmosis and biofilms and control strategies.”
is very large.

In this first working meeting, we want to work out the elements to create a guideline for the production of WFI based on membrane technology.

Who is invited:
All experts and professionals who can contribute to this topic with their experience and know-how.
The Guideline will be made available online to an international audience upon completion.

The main thematic blocks of our workshop are:
– Requirements for the final preparation stage
– Qualification & Monitoring
– Storage and distribution
– Sanitization
– Tour of the clean utility systems of the Pharma Biotech Production division.

Through active discussions of the participants, recommendations are formulated that can be applied in practice. They are intended to be points of reference for the development of lasting solutions and audit-compatible explanations of one’s own procedures. And serve as an aid for topic-related issues, such as GMP-relevant questions (e.g. in the context of audits).
The recommendations issued will be made available in electronic form on the ISPE D/A/CH website.
We would like to emphasize that this discussion is not a course!
Active cooperation of all participants is a condition.

In order to weight all topics from different perspectives, the participation of interested parties from relevant areas such as design, planning, manufacturers, suppliers and users is desired.
We ask you to prepare as many questions or experiences from your daily practice as possible for the event, which can then be discussed in the plenary.
All participants will receive the summary of the discussions, as well as the documentation of the presentations by EMail.

Please refer to the attached agenda for event details and schedule.

In order to keep the discussions effective and manageable, we will limit ourselves to a maximum of 50 participants.
Participation will be considered according to the order in which registrations are received.

Restrictions on competition may apply to visits to production facilities.

Download WS invitation letter
Download WS Agenda

Download WS Registration

Non-members may also participate in our events. If you want to become a member let us know when you register.

9. and October 10, 2017

Roche Diagnostics GmbH
Nun’s forest 2
82377 Penzberg

Questions about registration to Rolf Sopp(rolf.sopp(at)ispe-dach.org).


July 5, 2017
12:00 am