Medical Device Design: Dos and Don'ts - Special Considerations

  • Speaker:Dr. David Lim
  • Date: 4th June 2018 10:00 AM PST | 01:00 PM EST
  • Duration:60Min
  • Product Code:GRC-90299

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If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Description:

Medical device manufacturers are required to establish and maintain FDA-compliant quality management systems, where appropriate and applicable, including a design control subsystem.  

This presentation is intended to demystify regulatory requirements for a medical device design control system including design history file (DHF), device history record (DHR), and device master record (DMR).  It is further intended to provide practical, actionable and sustainable guidance on how to adequately implement design control requirements as a subsystem of the quality management system.  

This presentation will provide great opportunities to get familiar with design control requirements including DHF, DHR, and DMR and to become better familiar with how to adequately establish and follow design control procedures, to the extent, applicable to your device types. In particular, special considerations necessary for implementing a design control system will be discussed.  

Please join and have your design control system under check to ensure that critical factors have been taken into consideration and implemented to be compliant with the FDA’s design control requirements.. 

Areas To Be Covered in this Webinar:

  • Up to date Laws and Regulations
  • In depth Definitions
  • Critical Factors for Medical Device Design
  • Critical Factors during Device Development
  • Design Requirements
  • Design History File (DHF)
  • Device History Record (DHR)
  • Device Master Record (DMR)
  • Device Design – Dos and Don’ts
  • Common Pitfalls and How to Avoid
  • Enforcement Actions: Case Studies
  • PASS-IT Recommendations: Best Practices

Who will benefit:

  • R&D Scientists, Engineers, Managers, and Directors
  • Regulatory Affairs
  • Quality Professionals
  • Product Development Professionals
  • CROs
  • Consultants
  • Senior Management
  • Contractors and Subcontractors
  • Anyone interested in the subject

Instructor Profile:

Dr. Lim is one of leading industry speakers to provide training and instructional seminars on regulatory, quality, clinical, and compliance topics. 

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  is the President and Principal of Regulatory Doctor.  As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. 

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Available Options

Live Meeting Access Single: Attend the meeting Live via Webex Meeting

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Live + CD: Attend Live Meeting Online + Get the training CD shipped for free

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Live + USB - Attend Live online + Get the training USB shipped for free

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5 Member Group: 5 can Attend Live Meeting Online from any location globally

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10 Member group: 10 can Attend Live Meeting Online from any location globally

$849

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