Supplier Management Training

About The Course:

Design Controls are vital for the production of safe and effective medical devices, making them a critical process recognized by the FDA. Despite their significance, Design Controls often attract frequent 483 and Warning Letter observations. Join our immersive 2-day virtual seminar to gain comprehensive knowledge, develop robust processes, and implement competitive design control tools for your company. Discover how to seamlessly integrate design controls into your product development process, enabling streamlined development while ensuring top-tier quality and compliance.

This seminar exclusively focuses on Design Controls for medical devices. Uncover the essential requirements and learn how to efficiently translate them into effective processes tailored to your company's needs. Dive into the history, context, and specific requirements of design controls, exploring detailed tools and techniques. Engage in practical exercises that enhance your skills and refine your design control process.

Why You Should Attend:

Establishing the intrinsic quality, safety, and effectiveness of medical devices begins with a robust design phase. However, alarming statistics reveal that a significant percentage of medical device recalls stem from design problems, which can have catastrophic consequences for both customers and companies. To prevent such quality and compliance issues, implementing a rigorous and efficient design control process is crucial. Identifying and addressing issues early on leads to faster resolutions and safeguards against costly setbacks. Join our seminar to gain valuable insights and strategies to avert design problems and their detrimental impact on quality, cost, speed to market, and customer satisfaction.

Design Control stands as a critical area examined by the FDA during inspections of Medical Device Companies. Design-related issues can trigger customer complaints and medical device reports, while also posing challenges in manufacturability, including low yields, excessive scrap, and rework. Addressing and rectifying these issues early in the design phase yields far greater leverage compared to addressing problems in already-produced products. Our webinar offers an opportunity to learn from past issues, enabling you to enhance the quality and performance of your future product generations.

In this virtual seminar, students will understand the regulations, context, and history of design controls. They will learn how to use design control as a tool to ensure product quality while meeting business needs for speed to market. They will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference:
  • Expectations
  • Regulations and History
  • Design Control process, procedures, forms, records, files
  • Linkages to the rest of your Quality Management System
  • Lessons Learned
  • Myths
  • Challenges
  • Best Practices
  • FDA Inspection Readiness

  • Research and Department Engineers
  • Research and Department Project Leaders
  • Research and Department Managers and Directors
  • Individuals participating in Product Design and Development
  • Individuals participating in design changes and failure investigations
  • Regulatory Affairs Departments
  • Design Quality Engineers
  • Compliance Specialists
  • Auditors
  • Senior Management
  • Anyone new to Design Control


DAY 1 (10 AM to 3 PM)
Session 1:
  • Overview and Expectations
  • Background of FDA regulations
  • Design Controls as an integrated part of New Product Development
  • Design Planning
  • Project Management
Session 2:
  • Design Inputs
  • Design Outputs
  • Tools, forms, documents
Session 3:
  • Design Verification and Validation
  • Concepts
  • Strategies
  • Statistical techniques

DAY 2 (10 AM to 3 PM)
Session 1:
  • Design Review
  • Design History File
  • Documentation Requirements
Session 2:
  • Design Transfer
  • Design for manufacturability concepts
  • Design Changes
  • Change Control and configuration management
  • Linkages to other quality sub-systems
  • Risk Management
  • Failure Investigation
  • CAPA
Session 3:
  • Inspection Preparedness and Compliance Strategy
  • Lessons Learned, Myths, Challenges and Best Practices

Course Director: 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.

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