3-hr Virtual Seminar: Design Controls for Medical Devices
LOCATION:Attend Live Webinar
DATE:26-Oct-2016 : 1:00 PM EDT
DURATION:180 Mins
Speaker : Susanne Manz
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. 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.
Course Description:
Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality and the ensuring safe and effective products for your customers. This 3 hour webinar will cover the basics of design controls for medical devices. We will understand the requirements for design controls and how to translate them into an efficient and effective process for your company. Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase yet, statistics show, a significant percentage of all medical device recalls are due to design problems. A device recall can result in unplanned development costs, lost revenue for the manufacturer, and can significantly affect the end-user. Considering the relatively short life-cycle for market viability, it is in everyone's interest to "do it right the first time". Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development. As a result, the end user benefits from a safe and effective product and the manufacturer benefits from a successful return on investment. This webinar can help you create a design control process that is a competitive strength for your company.
Course Objective:
Understand regulations and expectations
Review enforcement case studies for lessons learned
Determine needed Processes and Procedures
Understand the Design Control Process
Understand how to build Design Control into your Product Development Process
Identify Best Practices
Prepare a Plan for Inspection Readiness
Course Outline:
In this course we will cover:
Overview and Definitions
FDA Expectations, Regulations
Lessons Learned and Enforcement Case Studies
Common Mistakes and how to avoid them
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
Best Practices
Preparing for an FDA or NB Inspection
Target Audience:
R&D Engineers
R&D Managers and Directors
Individuals participating in Product Design and Development
Individuals participating in design changes and failure investigations
Regulatory Affairs
Design Quality Engineers
R&D engineers and scientists
Compliance Specialists
Auditors
Senior Management
Please Click here to Enroll & for more details
Regards,
Joshua
Training Manager
Email: [email protected]
Call us at : 1-732-7225220
Website: compliance.world