Understanding Design Controls (to include Adaptive Designs for Clinical Studies) Webinar Details Date : February 13th Monday 2017
Time : 01:00PM ET / 10:00AM PT Duration: 90 Minutes
Key Take Away
Speaker : Charles H. Paul, President of C.H.Paul Consulting. Inc
This webinar will take you through Design Controls that manufacturers require to follow a sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety. It will cover all aspects of the Design Control process to prevent costly compliance/regulatory errors up to and including medical device recalls.
Overview Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation however the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed. Knowing how the FDA both views and examines design controls is crucial to achieving compliance throughout the life of the medical devices you manufacture and is one of the most valuable compliance subject areas to explore. Noncompliance in design controls, which are consistently uncovered by the FDA during inspections and examinations, are concerned with the design control process that has been designed and applied and the documentation required to support each design control step. The specific sections of the regulations that apply to design controls include CFR 21 Part 820 Quality System regulation found in Sec. 820.30 and Sec. 820.40. These sections of the regulation are extremely complex and difficult to apply particularly for companies that are new to the medical device field. This webinar will explore how design controls should be designed to meet both the spirit and intent of the regulation and the needs of both the medical device itself and the organization. Also covered briefly will be an explanation of the FDAâ€™s new guidance concerning Adaptive Designs for Medical Device Clinical Studies.
Why Should You Attend The number of medical device recalls over the past several years has almost doubled each year indicating that the FDA is increasingly looking at the medical device industry in general and how products are designed and managed in particular. Manufacturers are at significant compliance risk when their design control processes are flawed and are not carefully designed. Compliance risk has significant health and safety implications that medical device companies today can simply not ignore.
In of Adaptive Designs, an adaptive design process can significantly reduce resource requirements, reduce the time to study completion, and increase the potential for study success.
Areas Covered In This Webinar
An overview of the design control guidance for design controls A “drill down” through each step of the design control process An explanation and differentiation between verification and validation The Design Control Plan – its contents, functions, and uses The design control life cycle process An overview of Adaptive Design and the recently produced FDA guidance explaining it
Describe the regulatory guidance concerning design controls Explain each step of the design control process Define the iterative nature of the design control process and how Define validation and verification Explain the importance of and differences between design inputs and outputs Explain how validation and verification is accomplished What is the design control plan? Explain where in the process design verification and validation occurs Explain the Life Cycle process and how it relates to design controls in general Overview the Guidance document for Adaptive Designs for medical Device Studies Define Adaptive Design State the advantages and limitations of Adaptive Design Explain when adaptive designs should be chosen
Who Will Benefit
Quality Regulatory Compliance R&D Design and Development Manufacturing and Engineering Anyone involved in the Manufacture of Medical Devices that has had some exposure to the subject area and regulated environments
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.
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