Design Controls are essential for producing safe and effective medical devices. Therefore, Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This 2-day virtual seminar will help you understand, develop, and implement design controls processes and tools that are a competitive strength for your company. You will learn how to incorporate design controls into your product development process to help streamline development and ensure quality and compliance.
In this seminar, we will cover 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. The seminar will cover the history, context, and requirements for design controls. Discussion will include requirements and tools in detail and include exercises to help you practice and improve your design control process.
Why Should You Attend:
Why Should You Attend:
The intrinsic quality, safety, and effectiveness of medical device are established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. And those design problems can have disastrous results for your customer and for your company. A rigorous and efficient design control process can help avoid these quality and compliance problems. Issues that are identified early are more easily and quickly resolved. This seminar will help you avoid design problems and their impact on quality, cost, speed to market, and customer satisfaction.
Design Control is one of the critical areas covered by the FDA in inspections of Medical Device Companies. Design issues can also result in complaints from your customers and in medical device reports. Design issues can even create issues with manufacturability for your company including low yields and excessive scrap and rework. Finding and fixing issues early on in design provides much more leverage than trying to fix problems for products already in production. This webinar can help you learn from past issues and improve your next generations of product.
Learning Objectives:
Learning Objectives:
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
Who will Benefit:
- R&D Engineers
- R&D Project Leaders
- 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
- Anyone new to Design Control
