3 Sort-after Webinars on Design Control Guidance and IVDs for Medical Devices

The FDA has identified design control as a focal point in its inspectional approach to compliance. The Quality System Regulation 21 CFR Part 820 includes requirements for design controls. The regulation requires design validation to ensure your design or design changes will meet both defined user needs as well as your defined intended uses.
Instructor: David Lim, Russell Pizzuto
Product ID: PACK70020

This pack of 3 courses offered by Online Compliance Panel illustrates how to develop a robust Design Control System for medical devices.


CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants, as you wish.
  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
  • Free shipment of CDs within 72 hours from the date of purchase and reference materials will be mailed to your registered address.

Webinar Topics:


Who will benefit?

These webinar will be beneficial to the following:

R&D Scientists, Engineers, Managers, and Directors | Regulatory Affairs | Quality Professionals | Product Development Professionals| CROs | Consultants | Senior Management | Contractors and Subcontractors | Compliance Staff and Officers | Attorneys | Contractors/Subcontractors


Webinars included in the Package:

Implementing Design control for Medical Devices and IVDs (Duration: 60 Minutes)

Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs.

Objectives of the Presentation:

  • Federal Statutes and Regulations Governing Medical Devices in the US
  • Introduction and Definitions
  • Design and Development Planning
  • Design Input
  • Design Output
  • Design Review
  • Design Verification And Validation including Software Validation
  • Design Transfer
  • Design Changes
  • Design History File (DHF)
  • Device History Record (DHR)
  • Device Master Record (DMR)

Instructor Profile:

Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner. Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009,

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FDA Inspection and Medical Device Design Control (Duration: 60 Minutes)

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

Objectives of the Presentation:

  • To provide an opportunity to better understand and adequately implement adequate design control procedures and to survive an FDA inspection for design control requirements.
  • Statutes and Regulations Governing Medical Devices
  • Introduction and Definitions
  • 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
  • Design Control: Best Practices
  • Speaker's Recommendation and Suggestions on PASS-IT Solutions

Instructor Profile:

Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner. Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009,

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21 CFR 820 Best Practice, Requirements Traceability From Source Documents Through Design Validation (Duration: 90 Minutes)

This seminar will show you how to effectively integrate requirements tractability into your product development process. This systematic process links all User Needs, Intended Uses, regulatory requirements and functional requirements from source documents through Design Inputs, Design Output, Design Verification and Design Validation. This best practice will help ensure that your development programs and design changes have met all project design requirements related to safetyand effectiveness, and help demonstrates 21 CFR 820 Design Controls compliance.

Objectives of the Presentation:

  • How to define source document and design requirements
  • How to link to source documents: intended use, user needs, risk analysis, product spec, industry standards…
  • How to create a Traceability Matrix that traces:
    • Source document to Design Input (including Essential Design Inputs)
    • Design Inputs to Design Outputs to Design Verification and to Design Validation
  • Integration into a product development process and the DHF
  • How to use traceability in new product development and design changes
  • How this process systematically creates objective evidence and how to easily produce it during an audit

Instructor Profile:

Russell Pizzuto has 40 year of experience in engineering and management with 12 years in medical device design, manufacturing and regulatory compliance. As a Design Engineering, Project Engineer and Director of New Product Development he has developed hundreds of new consumer and industrial products for fortune 500 companies. As Global Director of Engineering for a major medical products manufacturer with teams in USA, Europe, China and Mexico he delivered Class I and Class II medical device projects.

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