2014 - FDA Inspection and Medical Device Design Control

Instructor: David Lim
Description:
According to the recent FDA enforcement trends (including 2013), inadequate design control is 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, as required by 21 CFR 820.30(a)(1)." Medical device firms are subject to design control requirements.
This webinar is intended to provide guidance on understanding, interpreting, and implementing design control procedures in a way to survive an FDA inspection. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs. In particular, this webinar will address how to best prepare for an FDA inspection concerning design control using real case examples.
Understanding, interpreting, and implementing 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 to be safe and effective on a global market and saving enormous amount of your unnecessary time, efforts and investment.
In this presentation, you will get familiar with design control requirements and the FDA inspection concerning design control systems applicable to all types of medical devices including IVDs. This webinar is a must for medical device and IVD firms including anyone interested in the topics from other industry.
Why Should you Attend:
To learn and ensure a design control system is adequately implemented to survive an FDA inspection.
Objectives of the Presentation:
To provide an opportunity to better understand and adequately implement adequate design control procedures and to survive an FDA inspection for design control requirements.
Statutes and Regulations Governing Medical Devices
Introduction and Definitions
Design and Development Planning
Design Input and Design Output
Design Review
Design Verification And Validation
Design Transfer and Design Changes
Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR)
FDA Inspection for Design Control
Common Mistakes and How to Avoid
How to Prepare for FDA inspection for Design Control
Design Control: Best Practices
Speaker's Recommendation and Suggestions on PASS-IT Solutions
Who can Benefit:
R&D
Quality Professionals
Compliance Staff and Officers
Regulatory Affairs
CEOs
VPs
Attorneys
Clinical Affairs
Consultants
Contractors/Subcontractors
Anyone Interested in the topic
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