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Compliance4All to organize 3 Hour Virtual Seminar on Design Controls for Medical Devices on July 19

Netzealous LLC DBA - Compliance4All
Posted on: 28 Jun 18
Compliance4All to organize 3 Hour Virtual Seminar on Design Controls for Medical Devices on July 19

Fremont, CA: A three-hour webinar on Design Controls for Medical Devices is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, on July 19. The aim of this webinar is to help participating organizations learn the ways of creating a Design Control process that is effective, efficient and compliant.
Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the expert at this webinar. Please visit http://bit.ly/2yZEoPh to enroll for this webinar.
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Design Controls for Medical Devices is of paramount importance in ensuring product quality. Errors that seep in during the design phase are usually difficult to correct at a later stage of the product lifecycle, and can lead to a whole lot of undesirables like a dent in customer confidence and satisfaction and MDRs, and could invite penal actions from the regulatory authorities in the form of issuance of 483s or Warning Letters, and even recalls.

This makes it critical for medical device manufacturers to create a Design Control process that seamlessly incorporates Design Control right into every stage of the product development process. At this webinar, Susanne will show how to create a Design Control process that is effective, efficient, and compliant.

All about Design Controls to ensure predictable outputs
Over the three hours of this webinar, Susanne will explain the basics of Design Controls for medical devices. A proper understanding of Design Controls, which are an integrated set of customer-focused management practices aimed at ensuring quality and consistency, will be offered. The direct result of implementing an effective and efficient Design Control process is that the manufacturer has a predictable product development process that gives improved quality and a greater level of compliance.
Susanne will demonstrate how to create a Design Control process that can become a competitive strength for the participants’ organization. Participants will get a better understanding of the regulations and expectations, understand the Design Control process better, will be able to put risk assessment and management techniques to better use, can get a strong grasp of best practices, and will be in a position to prepare a plan that helps them meet the expectations of inspectors and the regulatory guidelines. She will give them the opportunity to review enforcement case studies for the lessons they learn at this webinar.
This webinar will cover the following areas:

    Overview and Definitions
    FDA Expectations, Regulations
    Design Control Process
    Design and Development Planning
    Design Inputs
    Design Outputs
    Verification
    Validation
    Risk Analysis (Management)
    Design Review
    Design Transfer
    Design Changes
    Design History File
    Linkages to other Quality System Requirements
    Lessons Learned and Enforcement Case Studies
    Best Practices
    Preparing for an FDA or NB Inspection.

Editor's Details

Event Manager
Netzealous LLC DBA - Compliance4All
www.compliance4all.com
18004479407
support@compliance4all.com

Last updated on: 28/06/2018

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