Design Control Explained

Why Should You Attend:

FDA expectations for compliance with the Design Control requirements according to the CFR 820.30 have increased significantly in recent years. A well established design control process can not only make the devices compliant but also can eliminate the unnecessary wastes from the system.

This course will cover the essential areas of the Design Control and the methods to effectively improve / implement them within the existing or new product development process. The training will also cover the proven methods for effectively driving the entire process.

Learning Objectives:

• Understanding the CFR requirements.
• Getting ready for FDA inspection.
• Understand key areas of Design Control.
• Implementation of Design Control in existing product development process.
• Interfaces with risk management & usability engineering process.

Areas Covered in the Seminar:

• Code of Federal Regulations (CFR) related to Design Control.
• Understanding the terms used in the CFR.
• The scope of the Design Control.
• Linking various design control deliverables.
• Verification and Validation Highlights.
• Understanding Design Transfer.
• Design History File (DHF) process.

Who Will Benefit:

• R&D Engineers / Managers
• Quality Assurance Personnel
• Regulatory Affairs Personnel
• Advanced Manufacturing Personnel
• Manufacturing /Operations Personnel
• Consultants
• Quality System Auditors