John E Lincoln	Risk-Based CAPA Systems CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and key source of regulatory problems.
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John E Lincoln	Changes and the 510(k) The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
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Jeff Kasoff	Complaint Handling in Compliance with FDA and ISO Regulations Negative customer feedback about a product’s performance or safety is a strong indicator of whether a firm's manufacturing process is in control.
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Jeff Kasoff	Supplier and Internal Auditing The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day.
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Jeff Kasoff	Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner Supplier qualification and assessment is required in both the QSR regulations and ISO standards.
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Anthony DeMarinis	Sterilization as a Benchmark for Cleaning Validation and Control This webinar will review principles of sterilization validation and using them as a benchmark for more robust cleaning validation.
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Anthony DeMarinis	Root Cause Analysis: Shutting Down the Alligator Farm This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters.
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John Chapman	ISO 13485 as a Quality Management System for Medical Devices This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
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Edwin L Bills	Use of Risk Management during Process and Design Validation This presentation will discuss this critical interface between these three elements and give medical device manufacturers practical advice on implementation of a process that meets the requirements of all three areas.
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Edwin L Bills	Proper Documentation of Risk Management for Compliance with ISO 14971 This presentation will deliver a practical discussion on the proper use of the tools available to conduct product risk management and achieve a result that complies and also provides a more complete product risk analysis resulting in reduced cost and improved time to market with a lower risk product.
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