 |
|
| Associations |
|
| GS1 Germany |
|
|
 |
GS1 Germany is an independent service provider dedicated to promote the design and implementation of open, cross-industry and globally valid standards for identifying items and for the communication along the entire value-added chain. Based on these standards, GS1 Germany also develops recommendations for process improvements and streamlining operations and supports companies from a variety of business sectors in implementing them. Werum is GS1 Germany's solution provider and contributes with PAS-X Track & Trace to the global spread of GS1 standards.
For more information visit: www.gs1-germany.de |
|
|
|
| ISPE |
|
|
|
|
 |
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
|
 |
The ISPE affiliate D/A/CH serves 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 it organizes professional discussions and workshops. Current focus topics are
continuously tracked and discussed in the CoPs.
For further information visit: www.ispe.org
|
 |
Process Analytical Technology (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 was also largely involved in writing a QbD (Quality by design) / PAT
awareness document which explains how to create management awareness for
PAT.
|
 |
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)
|
|
|
|
|
|
| MESA |
|
 |
The Manufacturing Enterprise Solutions Association International (MESA) is a non-profit organization whose members are primarily manufacturing businesses and IT system providers. The association is a community of professionals who work with IT systems in industrial en-vironments. 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 |
|
|
|
| PDA |
|
|
 |
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 |
|
|
|
| German Engineering Federation "VDMA" |
|
|
 |
The VDMA represents over 3,000 mainly small/medium size member companies in the engineering industry, making it one of the largest and most important industrial associations in Europe. The VDMA covers the entire process chain - everything from components and plant manufacturers, system suppliers and system integrators through to service providers. The association reflects the varied customer-supplier relations all along the value adding chain, permitting both industry-specific and intra-industry cooperation.
Within the Food Processing and Packaging Machinery sector of the VDMA, Werum is actively participating in the activities of the VDMA working group "CFR 21-11 Interfaces".
For further information visit: www.vdma.org |
|
|
| WBF |
|
|
 |
The World Batch Forum (WBF) provides an open forum for the exchange of information related to the management, operation, and automation of manufacturing processes. The WBF documents best practices and guidelines for implementation of standards that apply to batch control and the exchange of batch data. The forum also organizes technical conferences and technical training programs.
Werum supports the WBF by sharing its manufacturing IT expertise with other forum members. Werum also participates to its two annual conference events in the USA and in Europe by exhibiting its software solutions for batch-based production. Werum is actively engaged in defining compliance requirements for the S95 ISA standard and describing the "Work Definition" concept (Part 4 of the S95 standard).
More information: www.wbf.org |
|
|
|
|
|
|
|
|
|
|
Werum worldwide
GS1 Germany