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.