Quality by Design for Medical Devices – Essential Techniques

MessageThis Webinar is over
Date Aug 2, 2018
Time 9:00 am to 5:00 pm
Cost 87,249.50
Online
Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This two-day seminar will help you understand, develop, and implement Design Controls processes and tools that are a competitive strength for your company. You will learn how to incorporate Design Controls into your product development process to help streamline development and ensure Quality and compliance.

Learning Objectives:
Using interactive discussion and exercises, students will understand the regulations, context, and history of Design Controls. They will learn how to use Design Control as a tool to ensure product quality while meeting business needs for speed to market. They will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference:
  • Expectations
  • Regulations and History
  • Design Control process, procedures, forms, records, files
  • Linkages to the rest of your Quality Management System
  • Lessons Learned
  • Myths
  • Challenges
  • Best Practices
  • Inspection Readiness
Who Should Attend :
  • R&D Engineers
  • R&D Project Leaders
  • R&D Managers and Directors
  • Individuals participating in Product Design and Development
  • Individuals participating in design changes and failure investigations
  • Regulatory Affairs
  • Design Quality Engineers
  • R&D engineers and scientists
  • Compliance Specialists
  • Auditors
  • Senior Management
  • Anyone new to Design Control

 


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