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