Quality by Design

Duration: 90 Minutes
This webinar will help you learn the basics of design controls for medical devices. This webinar will focus on the fundamental concept that quality cannot be inspected in--it must be designed in. We'll cover the regulations and expectations for design control. We'll discuss how design control fits into your Quality Management System. Successful integration can enhance your new product development process.
Quality by Design
Instructor: Susanne Manz
Product ID: 502012
Objectives of the Presentation
  • Overview and definitions
  • FDA expectations, regulations
  • Lessons learned and enforcement case studies
  • Common mistakes and how to avoid them
  • Design control process
  • Design History File
  • Linkages to other quality system requirements
  • Best practices
  • Preparing for an FDA or NB Inspection
Why Should you Attend
Intrinsic quality, safety and effectiveness of a device are known to be established during the design phase. However, statistics show a significant percentage of all medical device recalls are due to design problems. Because of this, Design Control is considered a critical process by the FDA. Yet it is still one of the most frequent areas for 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality and the ensuring safe and effective products for your customers. This webinar will cover the basics of design control for medical devices. We will discuss the requirements for design controls and how to translate them into an efficient and effective process for your company. A device recall can have disastrous impact for your customer, your reputation and your business success. This webinar can help you avoid common problems and create a design control process that is a competitive strength for your company.

Who will Benefit
  • Quality Systems Specialists
  • Design Engineers
  • Quality Engineers
  • Quality and Compliance Specialists
  • Internal Auditors and Managers
  • Training Specialists
  • Supplier Quality Engineers and Auditors
  • Quality/Compliance managers or directors for Medical Device companies
  • R&D Leaders
  • R&D Project Managers
  • General Managers wanting to learn how to understand Quality System requirements
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Training USB Flash Drive
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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:
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

Susanne's new book on Medical Device Quality Management Systems - Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
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