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Thursday, April 12 • 8:30am - 10:00am
Session GG - Beyond Compliance/Other

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GG-1  Metrics that Matter: Quality Service Indicators

What is easy to measure does not always yield meaningful results.  For example, when interviewing a Quality Assurance professional, you can query the number of audits completed.  Should the quantity be high one may infer the candidate is highly experienced. Through follow-up questions, it may become clear that the individual worked only as a co-auditor on a single program.
This session shall discuss how to develop effective measures, review commonly collected metrics and suggest alternative quality indicators.  Attendees will learn about data collection methods such as surveys, a little about statistics (the "n") and suggested methods for communicating results to management.  These tools can be used across the GxPs across Stakeholders although examples will be from a business perspective.

Beyond Compliance

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GG-2  Beyond Just Compliance:  Using the Innovation and Creativity Processes in Addition to CAPA

CAPA is effectively your compliance and deviation management system. The CAPA process provides analytical techniques and methods that have been proven to fix and prevent problems but what about innovation? What about creativity and forward thinking? How can we go beyond Lean and Six Sigma to reach a true state of creativity and innovation?
Did you know that there are processes that can be followed closely to achieve innovation and creativity just as much as there are processes to keep companies in compliance?
Learn how to move above and beyond CAPA management and into creative and dynamic innovation. The author will instruct you in the latest risk-management thinking to exploit and facilitate innovative ideas and easily gain support from executives and from within even rigid company cultures.

As you would expect, this type of innovation and creativity along with compliance will completely change the dynamic of quality and R&D for the better!

Consider the following takeaways from this session:
-New inventive ideas that reap practical economic results
-Learn how to solve a problem without investigation and root-cause analysis
-Learn how to apply a risk-based system to exploit and facilitate innovative idea
-Learn how to distinguish between when to use the CAPA analytical technique and when to use innovative and creative techniques for improvement
-Learn how to incorporate R&D principles with quality principles

Beyond Compliance

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GG-3  Learnings from a Recently Implemented Metrics and Continuous Improvement Program

Within Biometrics at Biogen, we have a Quality Business Performance Team that monitors and reports monthly both performance and quality metrics.  Currently we are collecting 100 measures across Data Management, Statistical Programming and Biostatistics. The reporting of key metrics (for example, changes to final outputs and frequency of database unlocks) along with associated tolerance thresholds are discussed at a Business Operations Forum consisting of cross-functional Management and key Quality and Operational Leads. Actions and next steps are determined within a continuous improvement framework consisting of investigation of the issue, cross functional discussion, identification of root cause and preventive actions.
Our presentation will share initiatives that have been implemented to improve quality and performance within Biometrics such as the quality of final Tables, Listings and Figures, database lock and eCRF development.  In addition, we will share the evolution of our metrics and continuous improvement strategies that began as a manual process over a year ago.  At Biogen, the operational model for clinical trial execution is complex and ever changing.  We are focusing our efforts on partnering across our many vendors, as well as standardization and automation of collection and reporting of metrics.
Our metrics and continuous improvement strategy has brought transparency and awareness of quality to all members of the Biometrics team.  The result of this initiative has increased vigilance around performance and efficiency and is impacting how we approach quality in our organization.

Beyond Compliance

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avatar for Kerri Robles

Kerri Robles

Director, Quality Laboratory Practices, BMS

avatar for Kim Jackson

Kim Jackson

Senior Technical Field Services Process Architect, MasterControl, Inc
Kim Jackson has more than 10 years of experience in healthcare technology, information science, and project management. As a field services process architect, she works with FDA- and ISO-regulated companies to develop automated quality event management processes for use with best-in-breed... Read More →
avatar for Michelle Thompson

Michelle Thompson

Vice President, FDA Quality and Regulatory Consultants, LLC (FDAQRC)
Mrs. (Holbrook) Thompson has been working in quality assurance for over 15 years and joined FDA Quality and Regulatory Consulting (FDAQRC) in 2015. She completed her Bachelors of Science at North Carolina State University. Mrs. Thompson has been a Registered Quality Assurance Professional... Read More →

Thursday April 12, 2018 8:30am - 10:00am PDT
Platinum 3&4