GMP University - Change Control

Make Key Decisions Based on an Effectively Managing Risks in Your Quality System

Risk management is a key component to your Quality Management System, a regulatory requirement and one that has critical impact on your organization. KENX is excited to announce a conference the can dramatically affect your strategy surrounding your risk management program. KENX’s Quality Risk Management conference provides the knowledge and tools to develop, implement and maintain best-in-class procedures that impresses FDA investigators, benefits your organization and expands your professional development. This program guides you through the process of evaluating, managing and mitigating risks to your quality system.

Top 10 Reasons to Attend:

• Regulatory intelligence – Stay up to speed on regulatory thinking
• Know ICH guidelines and why you should care
• Discover the most under-utilized QRM tool in industry
• Minimize subjectivity is risk assessments
• Present your QRM program to an inspector
• Learn how to structure QRM training
• See Bayer’s journey toward a robust QRM program
• Go beyond FMEA – QRM tools you should be using (but aren’t)
• Create custom risk tools/risk-based approaches
• Go well beyond ICH Q9 and the basics

Personnel in the Following Environments Should Attend:

• QA/QC
• Risk management
• Regulatory affairs
• Compliance and auditing
• Internal auditing
• Quality engineers
• Manufacturing
• Laboratory

This event is also appropriate to business development and sales managers that offer innovative solutions for change control, risk management, statistics and validation.