Webinar On FDA Inspection and Medical Device Design Control

Event Details

Time: July 28, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Jun 26, 2015

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Event Description

Description :

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