Design Control Requirements Under 21 CFR 820.30 and ISO 13485 7.3

John E. Lincoln
From: Jun 07, 2023 - To: Dec 31, 2023
Recorded Webinar
  

Description

This webinar will provide valuable guidance to regulated companies in the development and implementation of Design Control Planning and Techniques for new product development under 21 CFR 820.30, "Design Control",  and ISO 13485 7.3.  Also regulatory compliance proof of "progress against the plan", and other activities requiring a planned documented rationale. It should be an important part of a company's IP (Intellectual Property). Follow the 10 required steps (both FDA and EU MDR)  to design control compliance in R&D. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Regular use can contribute greatly to the reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.

Areas Covered:-

  • Meet key design control requirements of the CGMPs/ISO
  • The 10 Key Elements of Design Control

Background:-

Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.

Why Should You Attend:-

The FDA expects companies to manage the regulatory requirements of design and/or change control, with consideration of all applicable standards.  How can the FDA's Design Control requirements, 21 CFR 820.30, actually facilitate this? The new EU MDR and its notified bodies are no different.  How can this be done from a project's inception?  How can a Project Leader ensure critical elements are not committed until late in the project when disaster looms? Growing high-profile field problems indicate that much design control is perfunctory, poor, or non-existent. Buy up-front time for proper project planning. Simple tools provide powerful compliance. These techniques are not rocket-science but require the implementation of formal methods with documented and defensible rationale. Use these tools to bring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against the plan".

Who Will Benefit:-

This webinar will provide valuable assistance to all regulated companies to ensure compliance with the design control requirements of 21 CFR 820.30 and ISO 13485 7.3 - under cGMP and EU MDR/CE-marking compliance. It will discuss and provide examples of the 10 key design control milestones and associated tasks and provide a major example for immediate use. This applies to companies in the Medical Device, and combination products fields. The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance / QAE
  • Production
  • R&D and Engineering

All personnel tasked with any new or changed device development responsibilities, and those who soon hope to be.

Training Options

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Recording
   $189  

Transcript (Pdf)
   $189  

DVD
   $199  

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