Medical Device Design Control Essentials Course

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.

SEMINAR OBJECTIVES		WHO SHOULD ATTEND
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

AGENDA

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.