Live -Webinar 2014 - Special Considerations during Medical Device Design: Dos and Don'ts

DESCRIPTION
This webinar is intended to discuss important aspects of medical device design and development.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), a medical device firm is subject to design control requirements, to the extent applicable during development including clinical trials and postmarketing.
Based on the FDA enforcement trends, design control failure are frequently cited in 483s and FDA warning letters.
FDA warning letters state “Failure to establish and maintain adequate procedures to control the design of the device in order to ensure specified design requirements are met.”
In addition, due to device design control failures, it has resulted in many device recalls.
This webinar is intended to provide guidance on what key considerations should be focused during medical device development under the surrounding circumstances. It is also intended to provide further guidance on how to establish and maintain design control procedures in a way to survive an FDA inspection applicable for all classes of medical devices including IVDs.
In particular, this webinar will discuss various device design failures as examples to greatly In particular, this webinar will discuss various device design failures as examples to greatly increase our awareness.
It should be noted that an adequate understanding, interpretation, and implementation of design control system requirements in a holistic manner can significantly contribute to your product quality and regulatory compliance, helping to ensure your innovative medical products safe and effective on a global market. As a result, your adequate implementation of design control will significantly contribute to saving an enormous amount of your unnecessary time, efforts and investment for a long term.
This webinar is a must for medical device and IVD firms conceptualizing, developing and marketing medical devices including anyone interested in the topics from other industry.
This webinar will provide great opportunities to streamline device design and development process including regulatory approval/clearances and postmarketing.
Why Should you Attend
You need to ask sets of questions during medical device concept phase for developing intended use/user needs.
It is important to ensure you are familiar with the regulatory requirements applicable for medical device design and development.
Based on the regulatory requirements, firms shall establish and maintain adequate medical device design control procedures.
Areas Covered in the Webinar
Statutes and Regulations
Device Design Concept
Definitions
Design and Development Planning
Key Considerations
Design Control System Components
Design Control Sub-Systems
Design Input and Design Output
Design Review
Design V and/or V
Design Transfer and Design Changes
Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR)
Common Mistakes and How to Avoid
How to Prepare for FDA inspection for Design Control
Best Practices based on Actual Cases
Speaker’s Recommendation and Suggestions on PASS-IT Solutions
Who will Benefit:
Regulatory affairs (associates, specialists, managers, directors or VPs)
Quality professionals (associates, specialists, managers, directors or VPs)
R&D (engineers, scientists, managers, directors or VPs)
Complaint and risk management personnel
Consultants
Contractors/subcontractors
CEOs
VPs
Clinical affairs (associates, specialists, managers, directors or VPs)
Other interested parties
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance