Design Control 21 CFR 820.30 – Webinar Interactive Presentation

65.00

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

Description

Duration: 70 min. (the average time to complete the training program, including final assessments).

Description: This 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

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.

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