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Home > All Products > Integrating FDA and Trending Requirements into your CAPA System
Integrating FDA and Trending Requirements into your CAPA System
Price: From $298.00 to $1,200.00
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Integrating FDA and Trending Requirements into your CAPA System
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 web seminar offers you a "how to" approach to effectively integrate the FDA's CAPA and trending requirements, providing you with the skills and tools necessary to develop a strong, sustainable and compliant CAPA System.
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Learn how to use trending to identify product quality issues
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Choose which technology to use for product quality trending
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Establish thresholds against which to analyze product quality trends
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Determine what actions to take when upper limits are surpassed
Who Should Purchase:
You will benefit from purchasing this event if you are a Vice President, Director or a Supervisor of the following departments at a pharmaceutical, biotechnology or medical device company:
Complaint Investigations
Product Complaints
Quality Assurance
Quality Control
Regulatory Affairs
Risk Management
Compliance
Product Safety
Logistics/Distribution
Legal
Public Relations
Call Center
Customer Service
This conference would also be of interest to law firms, health policy consultants, reverse logistics vendors and software and technology vendors.
About our Presenter:
Larry Mager, Vice President Consulting, PathWise
Mr. Mager has over 15 years of experience in the life science industry. He has held responsible positions within pharmaceutical as well as medical device manufacturing companies ranging from start-up entrepreneurial ventures to large multi-national, highly matrixed corporate organizations. He has executed senior management responsibilities and coached teams in both Quality Management and Operations Management roles. Mr. Mager is experienced in interrelated disciplines such as, quality assurance systems, supplier management, onsite investigations, quality control, lean manufacturing, product development engineering and results oriented management for continuous improvement.
Mr. Mager is a broad thinker with complete understanding of contemporary quality system practices enabling "out of the box" thinking for the design and implementation of sustainable systemic solutions. He possesses a global perspective and understanding of quality assurance requirements, and is able to effectively relate the quality function to the business as a whole. Mr. Mager holds patents pertaining directly to cardiovascular products currently being marketed, and holds a Bachelors of Science in Mechanical Engineering from the University of Wisconsin.
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