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!
Read More →2016 Life Sciences Outlook
There are many changes on the horizon for the life sciences industry. To help pharmaceutical manufacturers navigate the changes ahead Clarkston Consulting has generated the report below to highlight some of the trends and changes that will have the greatest impact on the industry at large. Clarkston Consulting is a leading management, operations & implementation consultancy firm that specializes in the life sciences industry. The report outlines the current state of the industry by looking at the regulatory environment, changes brought on by mergers, acquisitions, and divestitures, serialization challenges and the state of high value biologics, specialty and orphan drugs. The whitepaper then examines factors that will have the greatest impact on the industry in the years to come and provides insights on how the industry will be able to successfully respond. Explore strategies to overcome the challenges and take advantage of the opportunities in internal manufacturing, external manufacturing, operational excellence, quality management and compliance at the American Biomanufacturing Summit 2016!
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 →Younok Dumortier Shin: A speaker review of the American Biomanufacturing Summit 2015
We were fortunate enough to have Younok Dumortier, Director of Large Molecule Technology Platform at Janssen join us as a speaker at the American Biomanufacturing Summit last year. We caught up with Younok and asked her to share some of her opinions about the event and participating as a speaker. The American Biomanufacturing Summit is returning to San Diego in May 2016. Find out more about the American Biomanufacturing Summit 2016!
Read More →Addressing the Challenges in Biomanufacturing
The life sciences industry is evolving on a global scale. Shifting market demands, healthcare reforms and more stringent regulations are presenting new challenges to the industry at large. “It is particularly challenging to manage operations globally when dealing with vastly different regulatory review periods for new drug applications as well as making any significant changes to existing dossiers.” explains Ryan Cox, Director, Bulk Manufacturing at CSL Behring. Increased pressure to reduce the cost of healthcare in the US is pushing manufacturers to streamline processes while finding new ways to produce “bio-better” drugs that have a vastly improved pharmacological profile. To remain competitive “biomanufacturers must continue to focus on innovation in terms of making improvements to existing products” explains Ryan. As a result “the industry will need to become much more flexible and “lean” over the next 5-10 years.” Taking a holistic approach to the challenges and opportunities that biomanufacturers face, Generis’ American Biomanufacturing Summit 2016 will present attendees with first-hand case studies, strategies and best practices to advance manufacturing excellence, drive innovation and develop the necessary leadership strategies to ensure long-term success. Produced with the thoughtful input of some of the world’s leading organizations, this senior level program is designed to provide biomanufacturing executives with current trends and strategic insights on internal manufacturing, external manufacturing, operational excellence, quality management and compliance. Annually attracting 150 senior level delegates from across North America, this years program will provide delegates with strategies and insights to …
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