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Home
Serivices
Training
Course Offerings
Enrollment Information
Consulting
Areas of Expertise
Why Medgineering?
Submit a Project
Staffing & Recruiting
Staffing & Recruiting Overview
Business Resources
Candidate Resources
About
Partners
Course: Design Controls
Course Objective
Explore best practices in design controls using
actual warning letter
examples
to illustrate key points under 21 CFR 820 Subpart D.
Target Audience
Management & development engineers.
Topics of Study
Practical Design Controls
The Issues: 483 and Warning Letter Reviews
The Fixes: Common Strategies and Best Practices
The “Waterfall Model” Reloaded – Inputs vs. Outputs
Verification vs. Validation
Design Changes
Design Reviews
Request Enrollment information
Courses Available
Quality 101
Innovating with Quality in Mind
Design Controls
Risk Management
Process Controls
CAPA & Non-Conformances
Remediation 101