New Webinar Course – DESIGN CONTROL 21 CFR 820.30 – INTERACTIVE PRESENTATION TRAINING


DESIGN CONTROL 21 CFR 820.30 – INTERACTIVE PRESENTATION TRAINING (Buy Ticket Now)

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Availability: Right Now (Interactive Presentation)

Duration: 70 min. (the average time to complete the training program).

Description: This webinar course will introduce you to the activities that are required by FDA Design Control according to 21 CFR 820.30.

  • Design Controls – Why?
  • Design Controls – Regulatory History
  • Design Controls – What are they?
  • Design Controls – Scope
  • The Elements of Design Control
  • General Requirements 21 CFR  820.30 (a)
  • Design and Development Planning 21 CFR 820.30 (b)
  • Design Input 21 CFR 820.30 (c)
  • Examples of Design Input
  • Design Output 21 CFR 820.30 (d)
  • Examples of Design Output
  • Design Review 21 CFR 820.30 (e)
  • Design Verification 21 CFR 820.30 (f)
  • Examples of Design Verification
  • Design Validation 21 CFR 820.30 (g)
  • Design Transfer 21 CFR 812.30 (h)
  • Design Changes 21 CFR 820.30 (i)
  • Design History File 21 CFR 820.30 (j)
  • Design Control Summary

Why Should You Attend:
Developing a new medical device from concept to market introduction is a complex processs. Design controls are a regulatory requirement for medical devices. In the US, compliance with the design controls section of 21 Code of Federal Regulations (CFR) Part 820.30 of the Quality System Regulation (QSR), 1 which applies to the design and development of new products, and changes to existing devices, is mandatory for both investigational and commercial medical devices. The design control regulations provide a com – prehensive and systematic framework for device development.  Design Control is more than regulatory need is a framework for developing a succesfull and high quality product.

Who Will Benefit:

  • R&D Engineers
  • Regulatory Affairs specialist
  • Medical Affairs specialist
  • Clinical Affair specialist
  • Quality Engineers
  • Marketing

Certification Requirements: Students must view the entire program and successfully pass an online, multiplechoice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Designation Programs). Certificate will be printable in PDF format immediately after satisfying requirements.

Online Training Programs Include:
90 days of 24/7 access to individual eLearning courses.
An online final assessment with multiplechoice questions.
A Certificate of Completion.

GOTO DESIGN CONTROL FDA 21 CFR 820.30