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    THE DESIGN CONTROL PLAN – ITS CONTENTS, FUNCTIONS, 2017 - Understanding Design Controls (to include Adaptive Designs for Clinical Studies) -By AtoZ Compliance

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    Website https://www.atozcompliance.com/trainings-webinar/life-sciences/medical-devices/understanding-design- | Want to Edit it Edit Freely

    Category Medical Device,Clinical,Laboratory,medical device process validation training, medical device approval process, medical device clinical studies, medical device reporting for manufacturers, medical device fmea, FDA compliance training, Adaptive Design process, Medical Device validation & verification, Medical Device Design

    Deadline: March 29, 2017 | Date: March 29, 2017

    Venue/Country: Online, U.S.A

    Updated: 2017-02-21 17:46:07 (GMT+9)

    Call For Papers - CFP

    Key Take Away :

    This webinar will take you through Design Controls that manufacturers require to follow a sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety. It will cover all aspects of the Design Control process to prevent costly compliance/regulatory errors up to and including medical device recalls.

    Overview :

    Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation however the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed.

    Knowing how the FDA both views and examines design controls is crucial to achieving compliance throughout the life of the medical devices you manufacture and is one of the most valuable compliance subject areas to explore.

    Noncompliance in design controls, which are consistently uncovered by the FDA during inspections and examinations, are concerned with the design control process that has been designed and applied and the documentation required to support each design control step.

    The specific sections of the regulations that apply to design controls include CFR 21 Part 820 Quality System regulation found in Sec. 820.30 and Sec. 820.40. These sections of the regulation are extremely complex and difficult to apply particularly for companies that are new to the medical device field.

    This webinar will explore how design controls should be designed to meet both the spirit and intent of the regulation and the needs of both the medical device itself and the organization.

    Also covered briefly will be an explanation of the FDA’s new guidance concerning Adaptive Designs for Medical Device Clinical Studies.

    Why Should You Attend :

    The number of medical device recalls over the past several years has almost doubled each year indicating that the FDA is increasingly looking at the medical device industry in general and how products are designed and managed in particular. Manufacturers are at significant compliance risk when their design control processes are flawed and are not carefully designed. Compliance risk has significant health and safety implications that medical device companies today can simply not ignore.

    In of Adaptive Designs, an adaptive design process can significantly reduce resource requirements, reduce the time to study completion, and increase the potential for study success.

    Areas Covered In This Webinar :

    An overview of the design control guidance for design controls

    A “drill down” through each step of the design control process

    An explanation and differentiation between verification and validation

    The Design Control Plan – its contents, functions, and uses

    The design control life cycle process

    An overview of Adaptive Design and the recently produced FDA guidance explaining it

    Learning Objectives:

    Describe the regulatory guidance concerning design controls

    Explain each step of the design control process

    Define the iterative nature of the design control process and how

    Define validation and verification

    Explain the importance of and differences between design inputs and outputs

    Explain how validation and verification is accomplished

    What is the design control plan?

    Explain where in the process design verification and validation occurs

    Explain the Life Cycle process and how it relates to design controls in general

    Overview the Guidance document for Adaptive Designs for medical Device Studies

    Define Adaptive Design

    State the advantages and limitations of Adaptive Design

    Explain when adaptive designs should be chosen

    Who Will Benefit :

    Quality

    Regulatory

    Compliance

    R & D

    Design and Development

    Manufacturing and Engineering

    Anyone involved in the Manufacture of Medical Devices that has had some exposure to the subject area and regulated environments

    For more information, please visit : https://www.atozcompliance.com/trainings-webinar/life-sciences/medical-devices/understanding-design-controls/charles-h-paul/300167?utm_source=ref&utm_medium=29Mar

    Email: supportatatozcompliance.com

    Toll Free: +1- 844-414-1400

    Tel: +1-516-900-5509

    Level:

    Intermediate

    Speakers Profile :

    Charles H. Paul

    Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm.

    Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.