Live Webinar Preventing Medical Device Recalls

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"Hear By Charles H Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years"

In a recent study, the FDA has reported a 95% increase in medical device recalls

Description

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.

Why should you attend :

In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2014 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.
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.  This webinar will address these issues particularly in terms of preventing recalls throughout the lifecycle of the device.

Areas Covered

-- Preventing recalls during specification writing
--      Preventing recalls during early design
--      Preventing recalls during the detail design phase
--      Designing for Prognostics to protect patients
--      Preventing recalls during production validation
--      Preventing software design recalls
--      Preventing supply chain quality defects to avoid recalls
--      Preventing recalls using a verification process
--      Preventing recalls using the design validation process
--      Role of management in preventing recalls
--      Innovative methods useful in preventing recalls

Who will Benefit

Anyone involved in the Design and Development of Medical Devices from R & D, Compliance and Engineering
Anyone involved in the Manufacture of Medical Devices

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Charles H Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues. 

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military. 

He has dedicated his entire professional career explaining the benefits of performance-based training

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