Course 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 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 results. This webinar can help you create a design control process that is a competitive strength for your company.
Why You Should Attend
An ineffective design control process leads to unwanted surprises, rework, and delayed product launches. 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. This webinar will help you to design quality into your products.
Course Objective
- Understand regulations and expectations
- Review enforcement case studies for lessons learned
- Understand the Design Control process and steps
- Use of Risk Assessment/Management Techniques
- Identify Best Practices
- Prepare a Plan for Inspection Readiness
Agenda
In this webinar, we will cover:
- 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 and documentation
- Linkages to other Quality System Requirements
- Lessons Learned and Enforcement Case Studies
- Best Practices
- Preparing for an FDA Inspection
Who Will Benefit
- 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
Faculty Susanne Manz
Consultant | Educator | Author
Baltimore, Maryland Area
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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices including roles as Worldwide Director of Design Quality, Worldwide Director of Product Quality, Executive Business Consultant, and Director of Corporate Compliance. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications in Six Sigma while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification from RAPS and Quality Auditor Certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.