Preventing Medical Device Recalls Webinar Details Date : October 06th Thursday 2016 Time : 01:00PM ET / 10:00AM PT REGISTER Duration: 90 Minutes Speaker : Charles H. Paul., President of C.H. Paul Consulting Inc. 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. Overview 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. 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

Learning Objectives Who Will Benefit Speakers Profile 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 Learning Objectives Explain the key techniques for avoiding medical device recalls during each phase of the medical device development process to include: Specification writing 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 Speakers Profile 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. AtoZ Compliance, 2754 80th Avenue, New Hyde Park, NY 11040 Email: support@atozcompliance.com Toll Free: +1- 844-414-1400 Tel: +1-516-900-5509 Fax: +1-516-300-1584 Our support team is available from 9:00AM - 5:00PM Eastern; Monday to Friday