Overview:
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 you should 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
Speaker
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. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.
Who Should Attend
- 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 Investigations
- Regulatory Affairs
- Design Quality Engineers
- CAPA Specialists
- Compliance Specialists
- Auditors
- Senior Management
