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.
Objectives of the Presentation:
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
Why Should you 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. This webinar will help you to design quality into your products.
Areas Covered:
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
Instructor 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 worked at industry leading companies
such as GE, J&J, and Medtronic with an
extensive background in quality and
compliance for medical devices from new
product development, to operations, to
post-market activities.
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 while at Johnson and
Johnson. Susanne also holds Regulatory
Affairs Certification (RAC) from RAPS and
is a CQA (Certified Quality Auditor) 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.
Susanne's new book on Medical Device
Quality Management Systems - Strategies
and Techniques for Improved Efficiency and
Effectiveness, is now available on
Elsevier and Amazon.