Webinar On FDA Inspection and Medical Device Design Control

Description :

Medical device firms are subject to design control requirements.  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).”

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. 

This 60-min presentation will provide great opportunities to 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.

Areas Covered in the Session :

Applicable Laws and Regulations

Definitions

Design Control Requirements

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

Best Practices for Establishing and Maintaining a Design Control System

Speaker’s Recommendation and Suggestions on PASS-IT Solutions

Who Will Benefit:

R&D

Quality

Regulatory Affairs

Compliance Officers

CEOs

VPs

Attorneys

Complainant Managers

Managers (RA, QA/QC, CA)

Consultants

Contractors and Subcontractors

Anyone interested in the topic