Online Webinar 2019 - 6-Hour Virtual Seminar on Quality By Design: Design Controls for Medical Devices

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 6-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
Course Outline:
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 or NB 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
Speaker Profile
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, Worldwide Director of Quality Engineering, Worldwide Director of Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems.
Susanne is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting, with a mission to provide services to help medical device companies achieve world-class quality and compliance. Susanne is the author of Medical Device Quality Management Systems.