With pressures to drive down costs, remain compliant, and improve innovation and the safety of products, manufacturers across all industries are increasing their focus on quality management. Executives are relying on a variety of resources — across people, processes, and technology — to progress forward and achieve process excellence. But before a company begins an initiative related to improving quality maturity, it’s important to understand the various phases of maturity and to define objectives for how to advance maturity from one phase to the next. Ahead of the American Medical Device Summit, we spoke with Roxane Napoli, Associate Director of Product Marketing at IQVIA Quality Compliance, to discuss how organizations within the medical device space can progress forward and improve their quality management capabilities.
Read More →Maximizing Supplier Quality with Limited Resources
Q&A with NTS Unitek Prior to the American Aerospace & Defense Summit 2018, we spoke to NTS Unitek to discuss how to maximize supplier quality with limited resources. In this Q&A, we discuss best practices to strengthen a supplier quality management program, how A&D companies can ensure product quality and what strategies A&D companies can employ to streamline their inspections and audits. This is an excerpt from the Q&A Generis did with NTS Unitek:
Read More →De-Risking in the MedTech Industry
Risk analysis is an essential component of your quality management system. A mandatory task for every new medical device about to hit the market is creating an appropriate Risk Management Plan as required by ISO 14971, the international standard for applying risk management to the design and manufacture of medical devices.
Read More →Reduce Supplier Risk, Reduce Organizational Risk
Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. The Medical Device Industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk. According to Pilgrim Quality Solutions, one of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage suppliers, and in many cases, suppliers’ suppliers, thereby increasing overall risk. The plethora of regulatory requirements placed on Medical Device organizations, including the updates to ISO 13485:2016, reflect this new reality.
Read More →EQMS and Quality 4.0: Build a Successful Quality Strategy for a Life Science Company
Quality is a critical concern in life science manufacturing industries, and leaders across life science companies have many quality and compliance considerations. However, few of those concerns have the strategic impact that Quality 4.0 does. Quality 4.0 is the digitalization of quality management through the application of traditional and Industry 4.0 technologies to improve quality monitoring and outcomes. At its core, Quality 4.0 is the digital continuum of quality data combined with other data from sources such as manufacturing, machine sensors, supplier management, and in-service across a product’s life, new analytical insights derived from that data, and the organization-wide transparent consumption of insights.
Read More →Why You Need a New Quality Management System
With technology rapidly changing, a global market, and competition around every corner, quality is one of the most important factors in manufacturing. Quality in products and process will ultimately keep any organization relevant in today’s marketplace. Additionally, having an efficient, paperless, and compliant QMS System can give an organization a competitive advantage.
Read More →Leadership Strategies for Enabling Supplier Quality Management
When it comes to quality management, life sciences organizations all face a similar set of challenges derived from both the significant industry competition necessitating improved quality performance and reduced costs, and from ever-tightening regulatory compliance measures. Quality leaders in life sciences need to contend with these pressures while also meeting goals around innovation, and improving efficiency across the product development lifecycle in an industry that is relying more and more on a growing global network of suppliers, contract manufacturers, and other partnerships. The growing network of suppliers in life sciences means that visibility into supplier quality and across the value chain are more important than ever before, as an adverse event could quickly lead to recalls, fines, and irreparable brand damage.
Read More →How to Build Your Quality Nirvana: Q&A with Kari Miller of Pilgrim QMS
Quality management is an integral factor in the development, approval, and commercialization of medical devices. With the American Medical Device Summit approaching, we took a moment to sit down with one of the summit presenters, Kari Miller, Vice President of Regulatory and Product Management at Pilgrim Quality Solutions, to gather her insights on the challenges and opportunities in quality management and explore some best practices to create a Quality Nirvana. As Vice President of Regulatory and Product Management, Kari Miller is responsible for driving strategic product direction and delivery of industry best practice solutions to Pilgrim’s customer base. Working with customers, industry analysts, and regulators, as well as Pilgrim’s Development, Professional Services, and Support groups, Kari and her team are responsible for translating market and industry trends, along with customer and regulatory requirements, into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated Life Sciences market. Additionally, Kari leads the development of user documentation and solution presentations. Working with Pilgrim’s Customer Product Advisory Board, Kari is responsible for the company’s product roadmap, product partner relationships, and overall product direction.
Read More →“The Future is Bright” – Reflections on the American Biomanufacturing Summit
Tawni Koutchesfahani, Director of Supply Chain at Relypsa, recently attended our 2018 American Biomanufacturing Summit. One of her key takeaways from the event was around how the paradigm of manufacturing and QA operations is changing and the ways in which it needs to change. We asked her to share her thoughts on the Generis blog. The Future is Bright By Tawni Koutchesfahani, Director of Supply Chain, Relypsa Let’s take a step back and think about where we were 38 years ago. In 1980, Martin Cline made the first attempt to modify human DNA. By 1989, National Institutes of Health approved the first nuclear gene transfer in humans. Since 1989, there have been over 2,000 clinical trials completed. If we fast forward to where we are now, gene therapy is now being viewed as the key to our future for many therapies. Last year, the industry hit some key milestones. Kite Pharma received its approval with Yescarta, and Novartis succeeded with Kymriah. Though these are significant highlights, the past addresses rare diseases. In turn, manufacturing of the gene therapy meets the market for a small population. As these therapies get approval for commercialization, the manufacturing models are not currently made for large scale, which poses a threat for the market. Thus, the whole notation of how we have been manufacturing has to change. How we have been producing in GMP environments has to change. How we have been implementing our quality systems …
Read More →Quality Management in the Board Room
Building the Executive Business Case for EQMS According to Pilgrim, quality leaders today are facing new challenges and opportunities presented by changing global markets, disruptive technologies, new regulations, and social media. Their quality management maturity has not increased quickly enough to keep pace, largely due to chronic underinvestment. When done right, quality extends throughout the enterprise and provides unique value across all functions. However, quality is stuck in a catch-22. It must break out of the silo to achieve its potential value, but the lack of perceived value reduces support from other leaders and top executives. Support from top executives plays a crucial role in the long-term effectiveness of quality. Three elements that quality needs to thrive: Top-down support Executive voice Sustained resources
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