Effective Quality by Design (QbD) 2018

Topics

• Major considerations in the regulatory requirements for product design
• Unique product design and development requirements
• Simplifying the planning and execution phase of your product
• Insight into the GMP regulations
• Emerging medical device and pharma development
• Quality System requirements for your Design Control System
• 21 CFR 820, 210/211 and ISO 13485
• Design Control and manufacturing requirements per ICH Guidelines
• Risk-based Assessment
• Currently available FDA Guidance Documents
• Solid identification and documentation of root cause
• Essential component of a well-documented quality system
• Proof of evidence needed by regulators
• What data should you gather for each stage of product development
• How to sustain the life cycle of your medical product

Who should Attend

• Process Engineering Departments
• Manufacturing Departments
• Design Assurance Departments
• Research and Development Departments
• Quality Control Departments
• Quality Assurance Departments
• Regulatory Affairs Departments
• Document Control Departments
• QbD Consultants