Quality by Design - Regulations and Expectations
Duration : 90 Minutes
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
This webinar will help you learn the basics of design controls for medical devices. This webinar will focus on the fundamental concept that quality cannot be inspected in--it must be designed in. We'll cover the regulations and expectations for design control. We'll discuss how design control fits into your Quality Management System. Successful integration can enhance your new product development process.
Course Objectives:
Intrinsic quality, safety and effectiveness of a device are known to be established during the design phase. However, statistics show a significant percentage of all medical device recalls are due to design problems. Because of this, Design Control is considered a critical process by the FDA. Yet it 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 webinar will cover the basics of design control for medical devices. We will discuss the requirements for design controls and how to translate them into an efficient and effective process for your company. A device recall can have disastrous impact for your customer, your reputation and your business success. This webinar can help you avoid common problems and create a design control process that is a competitive strength for your company.
Course Outline:
• Overview and definitions
• FDA expectations, regulations
• Lessons learned and enforcement case studies
• Common mistakes and how to avoid them
• Design control process
• Design History File
• 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:
• Quality Systems Specialists
• Design Engineers
• Quality Engineers
• Quality and Compliance Specialists
• Internal Auditors and Managers
• Training Specialists
• Supplier Quality Engineers and Auditors
• Quality/Compliance managers or directors for Medical Device companies
• R&D Leaders
• R&D Project Managers
• General Managers wanting to learn how to understand Quality System requirements
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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