3-Hour Virtual Seminar on Design Controls for Medical Devices

Design control image-Webinar Compliance

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 3-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 result. This webinar can help you create a design control process that is a competitive strength for your company.

Why You Should 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.

Learning Objectives:

  • 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
Seminar Agenda:

  • 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
Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Engineering Departments
  • Regulatory Affairs Departments
  • Product Development Managers
  • Product Development Project Leaders
  • Individuals participating in Product Design and Development
  • Individuals Participating in Design Changes and Failure Investigations
  • CAPA Specialists
  • Compliance Specialists
  • Auditors
  • Senior Management

MD3688

Susanne Manz

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. 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 Certified Quality Auditor (CQA) certification 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.

Refund Policy

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT
  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance