Preventing Medical Device Recalls ? A Prevention Strategy


Charles H. Paul is Keynote Speaker at ComplianceKey. He is 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 sub........

Overview

In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2016 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 devise functioning, the need for proactive risk prevention becomes more and more evident.

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.

Why should you attend this webinar?

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.

Areas Covered in the Session:

Who can Benefit:

Medical device manufacturers
Anyone involved in the manufacturer of medical devices that have had some exposure to the subject area and regulated environments.




Webinar Id: LSHCCP006

Training Options:

Duration: 60 mins

 Stop, pause, and rewind: learn at your own place.

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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