Medical device developers are evolving and introducing new products and variants into the market. With this evolution comes a more complex and dynamic global supply chain. To help navigate this shifting terrain Dassault Systèmes generated the free webinar below to help guide developers through effective techniques to create an opportunity through traceability. Check out the 35 minute free Qmed webinar on Making Traceability Work for the Business: Effective eDHR and UDI to discover: The role of integrated manufacturing software in eDHR and UDI compliance Approaches to consider for traceability program improvements Questions to raise as you assemble the diverse stakeholders for such a project Check out the Webinar!
Read More →eBook: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences
Medical device manufacturers are operating in a constantly evolving environment. Aging populations, evolving healthcare systems and more stringent regulations will have a significant impact on how medical device developers operate and succeed in the years to come. With the American Medical Device Summit quickly approaching, we wanted to take a closer look at how medical device developers will be able to navigate and thrive in this shifting terrain. Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services, generated the eBook below to help developers address their most pressing challenges and enable a new collaborative model. Check out the eBook!
Read More →The Serialization Challenge
Successful serialization strategies require a global approach and considerations regarding installation and aggregation capabilities, traceability optimization and adherence to varying regional regulations. In order to better understand the serialization challenges and opportunities that pharmaceutical companies face, we sat down with the specialists from Clarkston Consulting to gather their insights. The eBook explores and explains: The Current Regulatory Landscape The Serialization Challenge Best Practices in Serialization Operationalizing a Serialization Program Check out the eBook below! eBook, The Serialization Challenge To hear insights on Manufacturing Excellence, CMO Strategies, Capacity Management, Quality and Compliance, join Clarkston Consulting at the American Biomanufacturing Summit taking place in San Diego next week!
Read More →Managing A Cold Supply Chain
In the build up to the American Biomanufacturing Summit, we sat down with James Klingelhoefer, Regional Sales Director at World Courier to discuss strategies to best manage a cold supply chain. In the article below, James discusses the challenges and opportunities in managing a cold supply chain, explains the most important elements to manage and provides advice to biomanufacturers who may be struggling with their cold supply chain management. Managing a Cold Supply Chain To hear more biomanufacturing insights, join the discussion on May 10 – 11, 2016 in San Diego, CA.
Read More →Operational Efficiency Whitepaper: Beyond Compliance
dMedical device manufacturers are facing increasing challenges in the development, production and commercialization of their devices. To offset rising costs, evolving regulations and increased pressure to speed time to market, manufacturers are streamlining their processes and implementing strategies that drive operational efficiency. Dassault Systemes has generated an informative white paper to help medical device developers drive innovation and improve operational efficiency by creating processes that incorporate quality, engineering, and regulations. Download the “Beyond Compliance” whitepaper to learn how to Connect the Dots Between Quality, Engineering, and Regulatory to Increase Innovation and Improve Operational Efficiency. To hear more from Dessault Systemes, Join the discussion at the American Medical Device Summit 2016 taking place in Chicago on Oct 5th – 6th, 2016.
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!
Read More →Infographic: The Guiding Principles of a Quality Management System
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 →Achieving Operational Excellence in Biomanufacturing
Operational excellence is a key area of focus at the American Biomanufacturing Summit taking place on May 10-11 in San Diego. With the event less than 8 weeks away we decided to sit down with Seth Davies and Shane Yount the Managing Director and Principal at Competitive Solutions Inc. to hear their opinions on the challenges and opportunities available to biomanufacturers implementing operational excellence programs. We asked: What are the main obstacles that hamper decision-making, internal communication, and accountability? What are some of the options biomanufacturers have when trying to overcome these obstacles? What factors play an important role in achieving operational excellence? What role does employee engagement play in developing and maintaining a sustainable governance model? How can manufacturers assess the current level of employee engagement? What are some best practices that biomanufacturers can adopt to help them achieve progressive and sustainable governance? How can adopting a Process Based Leadership model help drive operational excellence and sustainable governance? eBook, Operational Excellence Explore strategies to streamline processes and achieve operational excellence at the American Biomanufacturing Summit 2016.
Read More →What to expect from the American Biomanufacturing Summit
We were thrilled that Robert Sparadoski, Associate Vice President, Quality Assurance at Ferring Pharmaceuticals could join us as a Chair at the American Biomanufacturing Summit 2015. We caught up with Robert to gather his opinions of the event as a whole. The American Biomanufacturing Summit is returning to San Diego in May 2016. Find out more about the 2016 Summit!
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