Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR

Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR is organized by ComplianceOnline and will be held on Oct 22, 2021.

Who Will Benefit:
• R&D Engineers
• 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

Why Should You Attend:
Design Controls are an integrated set of customer focused management practices to ensure quality and consistency. A rigorous Design Control process results in more predictable product development and improved quality and compliance results. And, if you’re selling medical devices in other countries, it is important to understand the differences between Design Control requirements found in FDA 21 CFR 820.30 and the requirements of ISO13485:2016 7.3 Design and Development. This webinar can help you create a design control process that is a competitive strength for your company and meet the expectations of different regulators.

Description:
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 90-minute webinar will cover the essentials of design controls for medical devices.

Learning Objectives:
• Understand regulations and expectations
• 21 CFR 820.3 and ISO13485:2016
• Understand the Design Control Process
• Identify key differences and solutions
• Identify Best Practices
• Prepare a Plan for Inspection Readiness

Areas Covered in the Webinar:
• Overview and Definitions
• Design Control Regulations
• Design Control Process
• Planning
• Design Inputs
• Design Outputs
• • Verification
• Validation
• Design Review
• Design Transfer
• Design Changes
• Design History File
• Summary of differences between QSR and ISO13485:2016
• Linkages to other Quality System Requirements
• Lessons Learned and Enforcement Case Studies
• Best Practices
• Preparing for an FDA or NB Inspection