- THE MAGAZINE
- WEB EXCLUSIVES
Date: May 12, 2009
Time: 11 a.m. EDT
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TAMPA, FL-Pilgrim Software presents a free Webinar, Mistake-Proof CAPA: Using Mistake Proofing to Reduce Human Error, given by Lisa R. Smith of Working Words Inc.
Smith is a senior consultant and technical trainer with Working Words Inc., which specializes in quality systems and process improvement, as well as training in technical, regulatory and medical writing for the pharmaceutical/biotechnology/medical device industry. Lisa has more than 20 years of management experience in applying quality and process improvement tools to manufacturing and laboratory operations. She is a certified lean Six Sigma master black belt and has led project teams in improving processes for: CAPA systems, batch record review, manufacturing change-over, out-of-specification investigations, management and quality assurance data systems, environmental monitoring and more. Prior to joining Working words, Lisa was an operational excellence manager at Biogen Idec, and served in various roles at Wyeth, Bespak, W.L. Gore and Boeing.
A robust CAPA (corrective and preventive action) system is a requirement for all FDA-regulated industries-including biotechnology, medical device and pharmaceutical manufacturers-and is an essential part of the quality management system. Because of this requirement, FDA, European and Japanese regulators are less tolerant of root causes identified as “operator or analyst error,” and they expect to see systems where human error is reduced.
In general, the corrective and preventive actions that are recommended to address human error tend to be “retraining” or “counseling” of the operator, which are usually ineffective and do not prevent recurrence of the problem. Because the average nonconformance or deviation can cost a company at least $15,000 (much more for serious events), the business and financial benefits of reducing recurrence of these events are obvious.
Mistake-proofing (Poka Yoke) is a proven tool for reducing human error in manufacturing processes that has been used in non-life science industries for years. By using mistake-proofing concepts in determining effective CAPA, life science companies will help prevent human error in manufacturing and develop systems where “the operator” is no longer seen as the cause of most problems. Such systems demonstrate controlled manufacturing processes to FDA and other regulatory agencies, reduce costs by preventing problems in manufacturing, and help create a better culture of quality throughout manufacturing operations.
During this webinar, Smith will address:
At the conclusion of the presentation you will understand:
Who should attend this Webinar?
Quality, Regulatory, Manufacturing, Operations, Compliance
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