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Design for Quality and Compliance
- Overview and Definitions
- FDA Expectations, Regulations
- Design Control Process
- Planning
- Design Inputs
- Design Outputs
- Verification
- Validation
- 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
Overview of the webinar
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 basics of design controls for medical devices. Design Controls are rigorous, methodical, and integrated management practices that are customer focused and ensure quality and consistency. This webinar can help you create a design control process that is a competitive strength for your company.
Who should attend?
- R&D Engineers
- R&D Managers and Directors
- Product Development Managers
- Individuals participating in Product Design and Development
- Individuals participating in design changes and failure investigations
- Regulatory Affairs
- Design Quality Engineers
- R&D Scientists
- Compliance Specialists
- Auditors
- Senior Management
Why should you attend?
Design Control is not only a regulatory requirement, it is a set of aligned practices that deliver a predictable design process leading to better product development projects and more successful products.Without good design controls and risk management, medical device companies will experience product design problems, an unpredictable product development process with resultant surprises, and reduced customer satisfaction.This webinar can help you to use design controls to design and launch new product in to meet quality objectives and business needs in an efficient and predictable manner.
- Understand regulations and expectations
- Review enforcement case studies for lessons learned
- Understand the Design Control Process
- Understand connection to Risk Management
- Identify Best Practices
- Prepare a Plan for Inspection Readiness
Faculty - Miss.Susanne Manz
Susanne Manz 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 Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) 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.