Design Control Basics 2018

Topics

• FDA Expectations, Regulations
• Overview and Definitions
• Planning
• Design Control Process
• Design Outputs
• Design Inputs
• Validation
• Verification
• Design Transfer
• Design Review
• Design History File
• Design Changes
• Lessons Learned and Enforcement Case Studies
• Linkages to other Quality System Requirements
• Preparing for an FDA or NB Inspection
• Best Practices

Who should Attend

• R&D Managers and Directors
• R&D Engineers
• Individuals participating in Product Design and Development
• Product Development Managers
• Regulatory Affairs
• Individuals participating in design changes and failure investigations
• R&D Scientists
• Design Quality Engineers
• Auditors
• Compliance Specialists
• Senior Management