3-hr Virtual Seminar: Design Controls for Medical Devices
Duration : 3 Hours
Susanne Manz,
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 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 Engineerin Read more
Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality and the ensuring safe and effective products for your customers.
This 3 hour webinar will cover the basics of design controls for medical devices. We will understand the requirements for design controls and how to translate them into an efficient and effective process for your company. Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase yet, statistics show, a significant percentage of all medical device recalls are due to design problems.
A device recall can result in unplanned development costs, lost revenue for the manufacturer, and can significantly affect the end-user. Considering the relatively short life-cycle for market viability, it is in everyone's interest to "do it right the first time".
Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development. As a result, the end user benefits from a safe and effective product and the manufacturer benefits from a successful return on investment.
This webinar can help you create a design control process that is a competitive strength for your company.
Course Objective:
• Understand regulations and expectations
• Review enforcement case studies for lessons learned
• Determine needed processes and procedures
• Understand the Design Control Process
• Understand how to build Design Control into your Product Development Process
• Identify best practices
• Prepare a plan for inspection readiness
Course Outline:
• Overview and Definitions
• FDA Expectations, Regulations
• Lessons Learned and Enforcement Case Studies
• Common Mistakes and how to avoid them
• Design Control Process
o Planning
o Design Inputs
o Design Outputs
o Verification
o Validation
o Design Review
o Design Transfer
o Design Changes
o Design History File
o Linkages to other Quality System Requirements
• Best Practices
• Preparing for an FDA or NB Inspection
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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