The rough breakdown of medical device failures is 60% residing with the product specification and only 30% of the errors in the components themselves. This rough breakdown indicates that most of the problems are referred to as management errors – caused by faulty systems, processes, and conditions. A failure of procedures and execution. In other words, management failure. In this webinar, learn the strategies to prevent such medical device recalls.
The secret to preventing medical device recalls is to implement and follow basic practices for specifications and design control, design for process reliability, production validation and design validation using accelerated life tests. This webinar is about controlling safety risk from specification writing to device retirement – control throughout the product’s life cycle.
The webinar will provide an overview and a foundation for further learning concerning preventing recalls during specification writing, risk assessment and risk management, preventing recalls during the early design and the detail design phases of development, and preventing recalls during validation, verification, and software design.In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine-year period ending in 2017 attributable to a variety of reasons. Whatever the reason, medical device recalls are expensive and most importantly carry significant risk to the health and safety of patients.
The increase indicates serious failures in the processes and controls designed to ensure reliability, safety, and effectiveness of the recalled devices. As medical devices become more complex and software components become more critical to device functioning, the need for proactive risk prevention becomes more and more evident.Learning Objectives:
At the completion of this webinar participants will be able to:
President, C H Paul Consulting Inc
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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