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| Global Associations |
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| ISPE |
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The International Society for Pharmaceutical Engineering (ISPE) is a global association
of engineers and companies operating in the regulated manufacturing industries. The ISPE has more
than 23.000 members worldwide.
Through the participation in various Communities of Practice (CoP) Werum plays an active part in
the committee work of the ISPE. In this respect Werum can draw on its long-standing experience as
a software provider for the pharmaceutical industry and has a responsible and committed
role in the solution of current issues.
For further information visit: www.ispe.org
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The ISPE affiliate D/A/CH covers the countries of the German-speaking
region (Austria, Germany and Switzerland) and provides a regional platform for the exchange
of expert experiences and views in the field of pharmaceutical manufacturing. With this objective in
mind, it arranges and organizes professional discussions and workshops. Current focus topics are
continuously tracked and discussed in the CoPs.
For further information visit: www.ispe.org/germany-switzerland
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CoP Process Analytical Technologies (PAT)
Just one example of our active cooperation in ISPE committees is the PAT Community of Practice (CoP). With the new "risk-based approach" and
the PAT Guidance published to outline it, the FDA has started a paradigm change in pharmaceutical manufacturing and
control. This entails new challenges for the pharmaceutical industry. The objective of the PAT CoP is to master these
challenges with a comprehensive exchange of experience and information among industry, suppliers and regulatory authorities.
Werum provides the Co-Chairman of the global ISPE PAT CoP Steering Committee. This group is in close direct contact with the FDA.
Werum was also largely involved in writing a QbD (Quality by design) / PAT
awareness document which explains how to create management awareness for
PAT.
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CoP Good Automated Manufacturing Practice (GAMP)
The GAMP Forum is a committee of the ISPE and was founded to promote acceptance for the regulation and use of computer and control systems in the life-sciences industries.
The GAMP Group's most important publications are the GAMP Guidelines, which interpret the specifications of the FDA and European authorities in the form of GxPs (e.g. Good Manufacturing Practices).
The most recent guideline, GAMP 5, has been issued in 2007.
Werum is a member in the GAMP D/A/CH Steering Committee.
For further information visit:
Verein Deutscher Ingenieure
www.ispe.org/gamp (LogIn)
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| MESA |
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The Manufacturing Enterprise Solutions Association International (MESA)
is a non-profit organization whose members are above all manufacturing businesses
and IT system providers. It is a community of professionals who work with IT systems
in industrial environments. MESA covers a broad spectrum of activities ranging from
supply chain IT systems and enterprise-wide IT technology to product life cycle,
production and maintenance; and MESA is concerned with all aspects arising from
the interaction of various systems.
For further information visit: www.mesa.org |
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| PDA |
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As an International Association for Pharmaceutical Science and Technology the PDA is a
global non-profit association with more than 10,500 scientists as members who
work in the fields of research and development, manufacture, quality control and
regulation of pharmaceuticals and related products. The association also provides
numerous education and training programs for the public administration and university
sectors - i.e. for everyone who has a professional interest in pharmaceutical
sciences and technologies. The PDA has made it its mission to advance pharmaceutical
and biopharmaceutical technologies on an international level by promoting scientifically
sound and practice-oriented technical information and further education among industries
and regulatory agencies.
For further information visit: www.pda.org |
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| VDMA |
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The VDMA, the German Engineering Federation, is the largest industry
association in Europe. The 400 employees of this non-profit organization serve 3,000 member
companies from all fields of the capital goods industry. The VDMA represents above all small
and medium-sized enterprises in Germany. It is concerned with all factors of the entire
production process and promotes the cooperation among different industry sectors,
such as the cooperation between suppliers and customers. The VDMA has a focus on
current topics of the capital goods industry and dynamically supports the most
immediate needs of the industry.
Within the Food Processing and Packaging Machinery sector of the VDMA, Werum is primarily
involved in the activities of the VDMA working group "21 CFR Part 11 Interfaces".
For further information visit: www.vdma.org |
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| WBF |
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WBF provides an open forum for the exchange of information related to the management,
operation, and automation of manufacturing processes. WBF documents best practices and guidelines
for implementation of standards that apply to batch control and the exchange of batch data, as
well as conducting technical conferences and technical training programs.
Werum supports WBF by sharing its manufacturing IT know-how with other members and helping define the various
aspects of the S95 standard. Werum also participates to its two yearly conference events in the USA and in
Europe by exhibiting its solutions. Werum is actively engaged in defining conformance requirements for S95
and describing the "Work Definition" concept (Part 4 of the S95 standard).
More information: www.wbf.org |
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ISPE