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6 Hour Virtual Seminar on Quality By Design: Design Controls for Medical Devices

Friday, 24 May 2019 08:00 AM PDT, 11:00 AM EDT

Training Duration = 6 hrs                  Sponsored by Online Compliance Panel

Click Here to register $600.00

Click Here to register and receive CD recording $1,000.00

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.

This 6-hour webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency.

An effective and efficient design control process results in a predictable product development process with improved quality and compliance results. This webinar can help you create a design control process that is a competitive strength for your company.

Objectives of the Presentation:

  • Understand regulations and expectations
  • Review enforcement case studies for lessons learned
  • Understand the Design Control Process
  • Use of Risk Assessment/Management Techniques
  • Identify Best Practices
  • Prepare a Plan for Inspection Readiness

Why Should you Attend:

Mistakes made during the design phase can cause customer dissatisfaction, compliance issues, or even harm your customers leading to MDRs and even recalls. These mistakes are sometimes difficult to correct later in the product lifecycle.

It is important to understand and seamlessly incorporate design control into your product development process. In this webinar you’ll hear from an industry expert on how to create an effective, efficient, and compliant design control process. This webinar will help you to design quality into your products.

Areas Covered:

  • Overview and Definitions
  • FDA Expectations, Regulations
  • Design Control Process
  • Design and Development Planning
  • Design Inputs
  • Design Outputs
  • Verification
  • Validation
  • Risk Analysis (Management)
  • Design Review
  • Design Transfer
  • Design Changes
  • Design History File
  • Linkages to other Quality System Requirements
  • Lessons Learned and Enforcement Case Studies
  • Best Practices
  • Preparing for an FDA or NB Inspection

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.