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 →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
Read More →Benchmarks and Best Practices for Next-Generation QMS
In a recent study conducted for Pilgrim, quality and compliance professionals from the top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies were surveyed on the “state of the state” of the business, regulatory, and technology landscape of their current quality management systems (QMS). This research provides fresh insights into the state of quality and compliance management in the Life Sciences industry, as well as quantitative data which demonstrates that many Life Sciences companies are preparing for or embracing Next-Generation Quality Management practices.
Read More →Supplier Quality Management: SQM’s Rightful Role in Your Enterprise
While there are many ways to define quality, the most important definition of quality is from the customer’s perspective – perceived quality – as this impacts brand loyalty, revenue, market share, and margins. When customers directly engage with a product, they consciously and subconsciously compare it to previous experiences with similar and dissimilar products. Indirect experiences also influence perceived quality, such as by brand image and social media.
Read More →Webinar: ISO 9001:2015: An Implementation Perspective
Is your organization ready for ISO 9001:2015? Have you begun preparing to transition or get certified to the new standard? This webinar by Intelex Technologies features Peter Merril, one of North America’s foremost authorities on the implementation of ISO 9001. Peter shares his expertise and insights on how to proactively jump-start your transition. The webinar topics discussed include: An outline of the structure of the new ISO 9001:2015 standard; Discussion of interpretations and new terminology; and Practical tips to help organizations transition and meet the requirements of ISO 9001:2015. Watch Now Below!
Read More →Video: Christopher Murphy’s Experience At The American Biomanufacturing Summit
At the American Biomanufacturing Summit last May we had the opportunity to sit down with one of our key speakers, Christopher Murphy, VP, Operations at Genzyme to hear his thoughts on participating as a speaker and on the summit as a whole. The American Biomanufacturing Summit is returning to the Hyatt Regency La Jolla in San Diego on May 10th – 11th, 2016. To find out more about the two day summit taking place next month, visit: www.biomanamerica.com
Read More →eBook: Q&A with Brandon Varnau, Vice President and Head of Operations Quality, Sanofi Specialty Care
Our next eBook features industry insights and forecasts from Brandon Varnau, Vice President and Head of Operations Quality at Sanofi Speciality Care, one of the key speakers at the American Biomanufacturing Summit 2016. We asked Brandon: How biomanufacturing in the U.S. differs from international operations? What are the biggest challenges biomanufacturers currently face? How can these challenges be overcome? What is the biggest opportunity in biomanufacturing? What do you foresee as the ‘next big trend’ to influence biomanufacturing? What major changes to you forecast the industry undergoing over the next 5-10 years? eBook Q&A with Brandon Varnau Brandon joins the speaker line up in San Diego this May to discuss strategies to Create a Quality Compliance Culture Within Biomanufacturing Facilities: Aligning manufacturing and quality objectives to ensure compliance Developing clear compliance expectations for all staff Empowering staff to proactively engage in a culture of compliance Examining various channels and knowledge sharing platforms to communicate compliance practices Find out more about the sessions, case studies and key themes to be addressed at the American Biomanufacturing Summit 2016!
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