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Pharmadule brings Chinese manufacturing insights to ISPE Annual Meeting 2014
Nacka, Stockholm: –Swedish-based designer and builder of modular production facilities for the life sciences industries, Pharmadule Morimatsu AB will use next month’s prestigious International Society for Pharmaceutical Engineering (ISPE) annual meeting in Las Vegas to present valuable insights on how to construct manufacturing facilities in China that comply with US and EU Good Manufacturing Practice (GMP) requirements.
Pharmadule’s Director of Regulatory Affairs, Magnus Jahnsson, will cover the intricacies of qualifying Chinese plants as cGMP when he makes his address as part of ISPE’s “Developments In Global Harmonization” section between 1300 and 1500 on Day One of the conference, Sunday October 12.
The session reflects the increasing momentum among Chinese pharmaceutical manufacturers to launch their products in EU or the US, as well as need for European and American companies to move production to China.
Mr. Jahnsson will team up with Daniel Nilsson, Director of GMP and Validation Services at Pharmadule Morimatsu, to present a case study in which a new facility for a biopharmaceutical product has been built and qualified with state-of-the-art risk management methods to US and EU standards.
They intend to show how a number of technical and cultural challenges can be overcome by a modern integrated and proactive validation management approach in a new biopharmaceutical manufacturing facility that incorporate streamlining, innovation and flexibility from the design stage.
Pharmadule will also be an exhibitor at ISPE 2014, showcasing design and build advantages of its innovative modular approach to turnkey plant construction.
Visitors to the Pharmadule display on Table 90 at the Caesars Palace convention center will be able to gain first hand insights from Mr Jahnsson and other members of the Pharmadule team.
“We have been regular attendees at ISPE for many years,” said Ulf Danielsson, Pharmadule Executive Vice President for Sales & Marketing.
“We look forward to sharing in the latest technical, regulatory and organizational developments and engaging in learning, problem-solving and relationship building with colleagues from all sectors of the global pharmaceutical industry,” said Mr. Danielsson.
“The meeting organizers are right to point out that pharmaceutical landscape is changing faster than ever, with life sciences companies having to find ways to do more with less and anticipate challenges almost before they happen,” he added.
“All these are areas where Pharmadule can help with a forward-looking approach to designing and constructing turnkey solutions that are fit for the future.”
About Pharmadule Morimatsu
Pharmadule Morimatsu designs and builds turnkey production facilities for the pharma and biopharma Industries. Pharmadule engineering and design services extend from conceptual design to IQ/OQ completion, offering a one-stop-shop suite of services that include: Front-End Design & Pre-Engineering, Detailed Design, Fabrication, Quality Assurance and Validation Management.
The company was founded in 1986, since when it has successfully delivered more than 70 projects worldwide for clients including Eli Lilly, Merck, Baxter, GlaxoSmithKline, Genentech and AstraZeneca, forging The Pharmadule Way as a way of offering unique value and reassurance to customers, with off-site construction and modular design concepts to provide very high predictability of on time, on budget delivery and consistent high quality, regardless of final location.
Since 2011, Pharmadule has been part of the Morimatsu Group of Japan, forming Pharmadule Morimatsu AB, headquartered in Stockholm, Sweden. The company also has a strong presence in the USA and Asia with engineering and manufacturing facilities in Shanghai, providing an enhanced service for clients in new markets.
About ISPE 2014
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association in this arena, committed to the advancement of the educational and technical efficiency of its members through creating forums for the exchange of ideas and practical experience. Founded in 1980, the Society now has more than 20,000 members in 90 countries.
The ISPE 2014 Annual Meeting will be held October 12-15 at Caesars Palace in Las Vegas, Nevada, combining an exhibition with keynote sessions, in-depth educational workshops, training courses and networking events. The event is themed ‘Exchanging Ideas. Advancing Technology. Expanding Networks’ to reflect increased challenges confronting the industry.
The 2013 ISPE Annual Meeting, held in Washington D.C, attracted more than 1,600 delegates from around the world.
More information at http://www.ispe.org/2014-annual-meeting
Maria Rosén Davidsson, Marketing Director, Pharmadule Morimatsu AB
Tel: +46 70 750 0036
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