WEBINAR OVERVIEW

The Life Science industry needs to have trained people they can count on to identify and investigate root causes and effectively implement solutions for corrective and preventive actions. Trending is an effective way to identify product quality issues, but there are many factors to consider when determining how to utilize the data that is collected through your CAPA system Companies must choose between the various methodologies and technologies that can be used to manipulate this data in order to make identifiable trends meaningful. Those responsible must also establish thresholds and guidelines to follow when a limit is surpassed.

This session offers attendees a how to approach to effectively integrate the FDAs CAPA and trending requirements, providing them with the skills and tools necessary to develop a strong, sustainable and compliant CAPA System.

Learn how to use trending to identify product quality issues:

I. Choose which technology to use for product quality trending
II. Establish thresholds against which to analyze product quality trends
III. Determine what actions to take when upper limits are surpassed

ABOUT THE SPEAKER

Mr. Larry Mager, Vice President of Quality and Compliance, has over 15 years of experience in the life science industry. Larry has held responsible positions within medical device manufacturing companies ranging from start-ups to large corporate organizations. He has executed senior management responsibilities and coached teams in both Quality Management and Operations Management roles, and brings an intimate understanding of third-party audits and quality system management.