Boundaries, Scope, and Major Elements of Medical Device Quality

Duration: 120 Minutes
This webinar will start with product development and then moves forward discussing the many cross-functional activities in this complex product lifecycle. The first focus is on the product and then designing it to meet customer requirements. The focus then shifts to developing the quality system that maintains the product and then uses the system to improve both the product and the process. Although Part 820 will be the dominant emphasis, frequent references will be made to ISO 13485 as well as ISO 9001.
Medical Device Quality Systems
Instructor: Howard T Cooper
Product ID: 500923

Areas Covered
  • Defining quality, quality system, and customer requirements
  • Introduction to Juran’s Quality Loop and its relationship to the product lifecycle
  • Cycling through the product lifecycle
  • Boundaries, scope, and major elements of Medical Device Quality Systems
  • Major factors that impact the planning and structure of the Medical Device Quality System
  • The relationship between risk and design
  • The Quality Manual
  • Quality System Requirements for product lifecycle segments
    • Product concept- R&D quality system, GLP, Design Control-GHTF (IMDRF) references
    • Product realization- GLP, Design Control-GHTF (IMDRF) references, 510K, PMA, GCP, EPA
    • Placing on the Market- GLP, Design Control-GHTF (IMDRF) references, 510K, PMA, GCP
    • Product use-GMP/GXP, product improvement
    • End of Product Life-GXP
    • “Destruction, disposal, manufacture, and “reuse ofp”. GXP, EPA.
  • Discussion of full-page handouts in graphical format
Why Should you Attend:
  • Those attendees new to quality systems will gain a high level view of quality systems and begin to see the intricacies and inter-functional activities that must be led and coordinated to successfully design and commercialize products
  • Those attendees who have had the opportunity to participate in product development, quality, and production will be better prepared to take on additional responsibilities
  • Experienced attendees will send new perspectives and gain insight that will help them design a new system or improve existing system
Objectives of the Presentation:
  • Understand how to define quality and its scope
  • Learn how quality systems function to deliver customer requirements in the commercialization of new medical devices
  • Gain practical knowledge, based on experience, for developing and establishing a new medical device quality system or revamping an existing quality system
  • Learn how to identify and implement product quality systems improvement
  • Understand the roles of all inter departmental functions that participate in product development and commercialization
  • Understand how to work with contractors in outsourcing of medical products throughout the product lifecycle
Who can Benefit:
  • Research and Development
  • Engineering and Design
  • Sales and Marketing
  • Accounting & Finance
  • Regulatory Affairs
  • Supply Chain
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Howard T Cooper has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which provided a very advanced and preventative approach toward quality systems. He quickly advanced to a managerial role experiencing responsibilities for quality management, quality system mitigation, and startup of new breweries. After leaving the brewing industry, he joined a medical device contractor when the Medical Device Amendments were being finalized. His first challenge was to establish a GMP system that met the needs of the large medical device clients that contracted with the company to produced finished medical devices. This very successful challenge led him to focus on startup quality systems and to mitigate failing quality systems.

His experience includes:
  • Designing and implementing Quality Systems from scratch in several startup operations.
  • Managing both single and multiple site quality operations
  • Assisted in revamping failing quality systems under warning letters and consent decrees
  • Advised large FDA regulated companies to improve their quality operations.

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