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Corrective and Preventive Action (CAPA) is a requirement under international standards such as ISO 13485:2016, ISO 9001:2015 and FDA under 21CFR 820 & is typically found in FDA Warning Letters.
This webinar will define and explain Corrective Action and Preventive Action requirements as found in ISO 13485 and FDA requirements. It will include discussions on root cause analysis, quality system trending, corrective action effectiveness, and how CAPA is critical to be linked to other parts of the quality system including customer complaints, manufacturing nonconformities, customer feedback, supplier performance, etc. Lastly, this course will include the consequences of poor adherence to these pro
Areas Covered in the Session:
· Regulatory Requirements
· Correction vs. Correction Action
· CAPA & Risk Management
· Determining Root Cause
· Tools for Root Cause Analysis
· Corrective Action Effectiveness
· Quality System Trending
· Linking CAPA to other parts of the QMS (Quality Management System)
Who Will Benefit:
Companies wishing to understand the risks and complications involved with a solid system of corrective action to document & resolve serious issues found in every medical device firm that can affect the bottom line. Employees who will benefit include:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. RAB Accredited Lead Auditor Course Certificate1996. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference. John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented live on-line seminars on various regulatory and quality system subjects.