Pharmadule presenting ‘quality culture’ insights at Shanghai summit

Nacka, Stockholm: – Swedish-based designer and engineer for the pharma and biotech industries, Pharmadule Morimatsu AB (Pharmadule) will present its thoughts on how to create a genuine ‘quality culture’ at the upcoming PharmaCon summits in Shanghai in late March.

Pharmadule Morimatsu Director of Regulatory Affairs, Magnus Jahnsson, will deliver one of the keynote speeches at the Pharmaceutical Regulatory Summit, one of three conferences that make up PharmaCon.

Organizing for quality

Mr. Jahnsson’s address, “Building a quality culture – not just a Quality Management System” will show how true embedded quality requires more than just QA/QC processes and management. Rather, it stems from enterprise-wide ethos, mindsets and leadership that embrace a ‘quality-minded way of working’.

Jahnsson will be able to draw on Pharmadule Morimatsu’s rich experience of process equipment, engineering and design in facility engineering and commissioning worldwide in which quality is inbuilt to every part of the operation.

Dynamic process

“Quality Assurance is a widely misunderstood term,” said Mr. Jahnsson. “Many managers and executives believe that it means following rules, guidelines and checklists to ensure compliance with regulations.”

“In Shanghai, I hope to demonstrate how true Quality Assurance is actually a dynamic factor that both impacts on, and measures the way an organization actually works,” he explained.

“This has to start with deep and visible commitment from the top of the organization and then extend down through team working and leadership, quality by design (QbD) and knowledge management, all the way to the shop floor,” added Jahnsson.

About Pharmadule Morimatsu

Pharmadule Morimatsu designs and builds turnkey production facilities for the pharma and biopharma Industries. Pharmadule services extend from conceptual design to IQOQ qualifications completion, offering a one-stop-shop suite of services that include: Front-End Design & Pre-Engineering, Detailed Design, Fabrication, Quality Assurance (QA) and Validation Management.

The company was founded in 1986, since when it has successfully delivered more than 60 production facilities worldwide for clients including Eli Lilly, Merck, Baxter, GlaxoSmithKline, Genentech, Pharmacia 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 Asia with engineering and manufacturing facilities in Shanghai, providing an enhanced service for clients in new markets.

About Pharmaceutical Regulatory Summit China

The Pharmaceutical Regulatory Summit China is a new conference primarily aimed at companies active in China’s rapidly growing pharma and biotech sectors.

It is one of three co-located conferences, along with Clinical Trials China and Pharma Compliance China that together make up PharmaCon China, a newly launched event.

The inaugural PharmaCon China will be a four-day event opening March 28 at Grand Hyatt Hotel in Shanghai.

Speakers at the Regulatory Summit will include representatives from leading companies such as Abbott and Pfizer as well as officials from regulatory bodies in Taiwan and Australia.

The Chinese Pharmaceutical market, currently the second largest pharma market globally, is forecast to almost double in size to an estimated $200 billion by 2020. The conferences seek to analyze the Chinese pharma business environment in terms of the issues affecting the drug development and research landscape.

PharmaCon is organized by Informa, with more information at: http://www.pharmaregulatorychina.com/home