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Quality by Design - Essential Techniques for Medical Devices

Date : 10 - 11 Jul 2018
Location : Washington DC, United States
Category : Healthcare

Design Controls are essential for producing safe and effective medical devices. And 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 two-day 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. We'll cover the history, context, and requirements for Design Controls. Then we'll discuss requirements and tools in detail and include exercises to help you practice and improve your Design Control process.

Why you should attend:

The intrinsic quality, safety, and effectiveness of medical devices 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 provide 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.

Price: $1,295.00
(Seminar Fee for One Delegate)

Get 5% off, register with us

Learning Objectives:

Using interactive discussion and exercises, 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
  • 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

Day 1 Schedule

Lecture 1 (90 Mins):

Overview and Expectations

Background of FDA regulations

Design Controls as an integrated part of New Product Development

Lecture 2 (90 Mins):

Design Planning

Project Management

Design Inputs

Lecture 3 (90 Mins):

Design Outputs

Tools, forms, documents

Lecture 4 (90 Mins):

Design Verification and Validation

  • Concepts
  • Strategies
  • Statistical techniques

Day 2 Schedule

Lecture 1 (90 Mins):

Design Review

Design History File

Documentation Requirements

Lecture 2 (90 Mins):

Design Transfer

Design for manufacturability concepts

Design Changes

Change Control and configuration management

Lecture 3 (90 Mins):

Linkages to other quality sub-systems

  • Risk Management
  • Failure Investigation
  • CAPA

Inspection Preparedness and Compliance Strategy

Lecture 4 (90 Mins):

Lessons Learned



Best Practices

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District of Columbia USA
Washington DC, United States