The Cost of Quality: a Study on Life Sciences


The Cost of Quality: a Study on Life Sciences
The Cost of Quality: a Study on Life Sciences webinar presents findings from the published report, The Cost of Quality: a Study on Life Sciences, a benchmark study by the AberdeenGroup. The report compares the quality standards and tactics of life science companies from the pharmaceutical, biotechnology, blood/biologics and medical device industries with those of Best-in-Class manufacturers. According to the report, "Aberdeen surveyed 169 […] companies identifying themselves as life science manufacturers."

Report Summary
In an earlier Aberdeen study, The Cost of Quality it was shown that "Best-in-Class manufacturers have distinct competitive advantages in performance metrics," which for life science manufacturers begs the question: How do these distinct competitive advantages relate to us?

In the Cost of Quality: a Study on Life Sciences, Aberdeen set out to determine where life science companies stand in terms of Best-in-Class status and what they can do to "improve performance while still conforming to regulatory bodies so that they may take advantage of practices used by Best-in-Class.” The study also addresses the distinct pressures life science manufacturers face in relation to other manufacturer types (i.e., their mandate to provide continual traceability). Also Included in the Report:
Here’s a sample of some of the findings provided in the report.

  • The top two pressures life science manufacturers face are adherence to government regulatory requirements (63%) and reducing the cost of quality (37%).
  • The top strategic action life science manufacturers take to better comply with the demands of regulatory requirements is to “build in” compliance and traceability to production processes (52%).
  • 80% of the Best-in-Class manufacturers have established interoperability between their plant floor automation (PFA) and their quality management system (QMS). Only 45% of life science companies have established this interoperability, leaving much room for improvement.

Added Bonus:
Bob Lundberg, Vice President of Regulatory Affairs and Quality Assurance at eVent Medical will also participate in the webinar. Bob will provide a short presentation on how software automation has helped eVent Medical to better comply with regulatory requirements while reducing the overall costs associated with that effort. Bob will also be available for the Q&A session following the webinar.

About the Webinar Presenters:

quality_life_science_aberdeengroup_0808_clip_image002_0000  Matthew Littlefield is a Senior Research Analyst for the Manufacturing   Practice at AberdeenGroup. In this position he studies how      manufacturing enterprises manage processes, technologies, quality, and   people to address continually changing market pressures. Matthew’s      research identifies the best practices of the most successful firms, which is then presented within the structure of Aberdeen’s competitive market framework. His areas of expertise include Industrial Engineering and Operations Research, Manufacturing Operations Management, Enterprise Quality Management, Lean Six Sigma, and technology interoperability. Matthew has been working with leading global manufacturers for the past ten years and leverages his experience in multi-mode manufacturing, Lean manufacturing principles, and technology implementation throughout his research.

 fonzi David Fonzi is a Sr. Research Analyst in the Global Manufacturing  practice which covers traditional plant floor automation, MES, QMS,    Lean, EAM, and EMI. He specializes in the interoperability between  various automation layers including ERP. He also covers solution delivery  of these technologies with a focus on process industries and life sciences.Prior to joining Aberdeen, David spent 12 years in technology consulting and project management, implementing various MES and PLM solutions to Fortune 500 companies. Prior to that, he was a software engineer for a major PLC vendor specializing in Batch Control and Process Control.David holds a B.S. in Chemical Engineering and Economics from Carnegie Mellon University and an M.S. in Chemical Engineering from the University of Massachusetts, Lowell.


quality_life_science_aberdeengroup_0808_clip_image004_0000 With over 20 years of experience in the medical device  industry, Robert Lundberg joined eVent Medical, Inc. as the VP of  Regulatory Affairs/Quality Assurance in August 2007. He has  responsibility for regulatory compliance and quality assurance for eVent Medical's locations in Aliso Viejo, CA; Galway, Ireland; and Buchs, Switzerland. eVent Medical designs and manufactures critical care respiratory ventilators.

Prior to his current position, Lundberg implemented 21 CFR Part 11 compliant electronic quality management systems in three different medical device companies, including a startup company that is now a well-established organization. These implementations included key processes such as design control, CAPA, complaint handling, change control, nonconforming materials, audits, deviations, calibration, and preventative maintenance.

Lundberg has a BS in electronics engineering and an MBA in technology management. He is a member of RAPS, OCRA and ASQ.