What Will FDA Expect And Request From Your Firm During Design Control Portions Of Inspections?

Location: Attend Live Webinar
Dates: 21-Jan-2015: 10:00 AM PST
Duration : 60 Mins

Speaker: David Lim, FDA

Dr. David Lim, Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting.

Course Description:

This webinar is intended to discuss important aspects of FDA inspection concerning medical device design control system. 

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 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.

Course Objective:

• 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.

Course Outline:

• Statutes and Regulations
• Medical Device Design Concept
• Definitions
• Design and Development Planning
• Design Control Components (Design Input/Output, Review, V & V, Design Transfer and Design Change)
• Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR)
• Common Mistakes: What and How to Avoid Them
• Common Citations for Design Control Violations in 483s and FDA Warning Letters
• How to Proactively Prepare for an FDA inspection for Design Control
• Best Practices based on Actual Cases
• Speaker’s Recommendation and Suggestions on PASS-IT Solutions

Target Audience:

• 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

Please Click hear for More  Information

To Enroll for This Program today  please click hear

Thank you & Regards,

Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

Call us at this Toll Free number: +1-866-978-0800

http://www.complianzworld.com