Quality System Regulations for Devicemakers: A Regulatory Approach 2015

Key Topics

• Demonstrate a proactive approach to quality and improve operational efficiency
• Multitude of what regulatory agencies are going to review relative to Quality Systems compliance
• Incorporate risk-management strategy to quality systems application
• Anticipate and meet FDA expectations for a compliant quality system
• Track and organize data efficiently to improve the evaluation process
• Build a quality-focused culture and facilitate management support for quality systems processes
• Integrate risk assessment activities into the product design process to meet expectations of "quality by design
• Apply effective documentation techniques through the product life-cycle to avoid confusion and manage changes
• Understand the elements of the and how each subsystem is interconnected to the rest in order to meet GMP requirements
• Identify crucial training issues to address job-specific compliance responsibilities
• Evaluate SOPs, design controls, and validation protocols from a quality perspective and make revisions or improvements as needed
• Conduct internal audits to monitor quality and apply corrective actions when appropriate
• Organize and manage evaluation data to improve product quality and address customer complaints

Who should Attend

• Interdepartmental functions associated with scaling up and commercializing a new medical product
• Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products
• Suppliers and software vendors, servicing the FDA regulated industries, who want to better understand the customer’s needs and requirements
• Regulatory Affairs working on approval of combination products