Video: Christopher Murphy’s Experience At The American Biomanufacturing Summit

In biomanufacturing, biotechnology, cGMP, Continuous Improvement, cost management, cost reduction, Enterprise Excellence, innovation, Life sciences, manufacturing, pharmaceutical, Qbd, QMS, traceability, workforce by GenerisLeave a Comment

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

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eBook: Q&A with Brandon Varnau, Vice President and Head of Operations Quality, Sanofi Specialty Care

In biomanufacturing, biotechnology, cGMP, Continuous Improvement, facilities, Life sciences, manufacturing, pharmaceutical, Qbd, QMS, Quality by design by GenerisLeave a Comment

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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Infographic: The Guiding Principles of a Quality Management System

In biomanufacturing, biotechnology, cGMP, Continuous Improvement, global quality system, Life sciences, manufacturing, operational excellence, Qbd, QMS, Quality by design, Quality Management System by Generis1 Comment

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.  

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Achieving Operational Excellence in Biomanufacturing

In biomanufacturing, biotechnology, Enterprise Excellence, governance, Life sciences, manufacturing, pharmaceutical, Qbd by GenerisLeave a Comment

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.

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Best Practices for Medical Device Development

In manufacturing, medical device, medtech, product design, product development, Qbd, Quality by design by Generis1 Comment

Medical device developers must take into account numerous safety, quality and risk factors to ensure the durability and safety of their devices. Developers must also adhere to strict risk management processes and life cycle requirements that may vary regionally. Our friends at Seapine Software have generated the whitepaper below to help developers navigate this shifting terrain and understand the best practices for exposing risk throughout the product development life cycle.   Exposing Risk Throughout Your Product Development Lifecycle Hear more from Seapine Software by joining the discussion at the American Medical Device Summit 2016!

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Infographic: Building a Culture of Quality in Biomanufacturing

In biomanufacturing, biotechnology, cGMP, cost reduction, Life sciences, manufacturing, operational excellence, pharmaceutical, Qbd, QMS, Quality by design, Quality System Management by GenerisLeave a Comment

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!

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