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Apr 4, 2016

Compliance, Innovation and GMPs at the 32nd SQA Annual Meeting & Quality College

MasterControl's Ken Peterson and 
Michael Alfano will address attendees at the 
32nd SQA Annual Meeting & Quality College.

by Robyn Barnes

Marketing Communications

MasterControl


If you’re not cultivating a culture of quality at your workplace, what are you doing to improve compliance, innovation and good manufacturing practices (GMPs)?

Ken Peterson and Michael Alfano of MasterControl will be addressing these questions at the 32nd SQA Annual Meeting & Quality College, to be held April 3-8 at the Gaylord Texan Resort & Convention Center in Grapevine, Texas. 

CAPA and Innovation


Peterson is a dynamic speaker, nationally recognized as a foremost expert on corrective and preventive actions (CAPAs) and innovation. Over the course of his career, he has worked closely with the FDA, and often speaks in partnership with them. He has implemented CAPA processes at many life science companies and trained numerous investigators.

Peterson’s presentation, “Beyond Just Compliance: Using the Innovation and Creativity Processes in Addition to CAPA,” will demonstrate how to move beyond traditional CAPA management and into creative and dynamic innovation. He is slated to speak at 8:30 a.m. Wednesday, April 6.

“CAPA is effectively your compliance and deviation management system,” Peterson says. “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? That’s what I’ll be addressing during my session.”

This article is related to the White Paper: Does Your CAPA Need a CAPA?To get the full details, please download your free copy.


Automation and ROI


Frequent SQA attendees will recognize Michael Alfano, a veteran at MasterControl, and an automated enterprise quality management system (EQMS) expert. His presentation, “Good Manufacturing Practices Automated: The ROI Benefits of Multiple Solutions in One Integrated Platform for General and Life Science Manufacturers,” is based on his experiences working with quality managers who need a better understanding of what an EQMS can do for them—and their company’s bottom line. His presentation is slated for 10:30 a.m. Wednesday, April 6.

“When quality is built into an automated solution, it becomes an ROI generator,” says Alfano. “Quality professionals aren’t used to thinking of quality or good manufacturing practices as tools for increasing ROI, but they certainly can be.

“In 30 minutes, I’ll explain the benefits of integrating multiple solutions into one automated platform and teach attendees how to demonstrate to executives a direct line from the platform to ROI," he says.   “I’ll also demonstrate how an integrated electronic system can create a more cooperative business environment and the value of using analytics in the GMP environment.”

Ken Peterson’s experience includes more than thirty years in consulting and organizational change, quality management and development. He is currently a member of Utah Technology Council’s life sciences board of advisors. 

His abilities extend beyond consultation and remediation to teaching the initial critical training programs needed to deploy many aspects of a successful quality management system. Peterson maintains a detailed approach to measurement and documentation and has a background in both human science and engineering.  He has consulted on numerous high impact problems and recalls to find root cause, saving companies millions of dollars.



Quality management software solutions expert Michael Alfano has been with MasterControl for nearly two decades. Prior to joining MasterControl, he worked at Janssen Pharma (Johnson & Johnson), Octagon Research (Accenture) and Omnicom Systems.