3-Hour Virtual Seminar on Design Controls for Medical Devices - Webinar

  • ID: 4600429
  • Webinar
  • 31 August 2018 10:00 PDT
  • 180 Minutes
  • NetZealous
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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 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.

Areas Covered in the Session:

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

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
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  • Susanne Manz Susanne Manz,


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  • R&D Engineers and Scientists
  • R&D Managers and Directors
  • Product Development Managers
  • Product Development Project Leaders
  • Individuals participating in Product Design and Development
  • Individuals Participating in Design Changes and Failure
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