Key Take Away:
This webinar will enable you to understand the classes of recalls and their relationship to deficiencies in the design and development process, how to develop a strategy for preventing recalls right from the beginning of the process and how the application of risk analysis is a valuable tool in identifying potential areas that could cause 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.
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.
Areas Covered In This Webinar:
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
Explain the key techniques for avoiding medical device recalls during each phase of the medical device development process to include:
During the early design phase
During the detail design phase
When designing for prognostics to protect patients
During production validation
During software design
When structuring the supply chain and establishing supply chain quality requirements
Explain how the effective application of the verification process can contribute to preventing device recalls
Define the role that design validation plays in preventing medical device recalls
Define the role that management plays in preventing medical device recalls
List and describe the 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
Charles H. Paul
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm.
Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
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