In today’s infographic we take a closer look at the guiding principles of a quality management system (QMS). The goal of a QMS is to maintain compliance, drive continual improvement and support efficient and flexible processes. A QMS is first established by assessing the short-falls of the current system and developing appropriate policies to achieve corporate quality goals. Once these are defined the standard operating procedures need to be implemented and personal buy-in from all levels of the organization must be achieved. Management will then monitor and review the outcomes, making additional adjustments to ensure continual improvement. Check out the infographic below for some quick insights on creating and monitoring a quality management system. For more in-depth information, strategies and best-practices attend the American Biomanufacturing Summit 2016 in San Diego this May.
Read More →Infographic: Building a Culture of Quality in Biomanufacturing
Quality management is a key focus at the American Biomanufacturing Summit 2016. Manufacturers are facing increased pressure to reduce product costs while producing “bio-better” drugs that have a vastly improved pharmacological profile. By implementing a quality management system biomanufacturers will be able to build consistency into their processes, improve efficiency, ensure profitability and drive operational and competitive advantages. Implementing a quality management system is no easy feat, the process requires an organizational evolution and involves the optimization of procedures, processes and resource allocation. To enable these changes an organization must first work to build an organizational culture that focuses on quality. The first infographic in our quality series has been created from the information presented by Tony Mire-Sluis, Vice President, North America, Abingdon, Singapore, Contract and Product Quality, Amgen Inc., at the American Biomanufacturing Summit last year. Find out more about building a Culture focused on Quality at the American Biomanufacturing Summit 2016!
Read More →Why You Should Create a Collaborative Culture in the Pre-Development Stage
The medical device industry has seen substantial growth in past years and the need for innovative, value-driven devices is rising. The sustainability of the current healthcare system, however, is dependent on minimizing spend and maximizing resources to ensure that for each dollar spent, there is some improvement to the health and quality of life of the individual. In order to achieve the necessary value and quality in the design of new devices, more and more manufacturers are striving to develop a collaborative culture in which the needs of the patient and those of the end user, such as the nurse, physician or other care giver, are taken into account during the pre-development stage. James Donnelly, Ph.D., Chief Scientific Officer, Global VP, Medical, Scientific & Statistical Affairs, Siemens Healthcare Diagnostics says “it’s not just how the patient benefits from a product, procedure, or test result—it’s everybody in between us and the patient that also need to be considered. It’s how the device and its functions will fit into their workflow and how it will add value to their system. You can build the best product in the world, but if they can’t use it in a way that is efficient and cost effective for them, it will fail.” “Device manufacturers need to look now and act fast to understand whether or not, in this changing environment, they are still creating products that represent today’s definition of state-of-the-art while anticipating what is needed in the future,” Donnelly says. “By bringing the patient and user perspective …
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