Systems • Risk • Change • Metrics CAPA • Data • Improvement
- Orlando, FL
Join us for IVT’s PharmaQual 360° — dedicated to establishing Good Manufacturing Practices and quality excellence throughout your organization. This conference addresses the top challenges faced by your quality unit while ensuring GMP throughout your Quality System.
The importance of GMP compliance has never been greater for the FDA-regulated industry. With a flood of regulatory scrutiny in the GMP environment from quality metrics to data integrity, attendance is critical for those working in the quality, validation and engineering environments. This in-depth and dynamic event highlights the best-in-class processes for you to take back to your organization and immediately implement.
Stay ahead of the curve with FDA and global regulations, learn how to measure quality with a compliant metrics program, address industry’s top inspectional findings and enforcement trends, implement an effective change control program, develop a compliant and effective CAPA program and so much more this February!
BEST-IN-CLASS EXAMPLES OF MANAGING THE CRITICAL AREAS OF TODAY’S QUALITY SYSTEM:
- Manage Product and Process Knowledge from Development through Commercial Life Cycle
- Discover Approaches to Evaluate and Strengthen Quality Culture
- Learn How to Prepare for and Host a Regulatory Inspection
- Ensure Your Quality System is in a State of Control
- Use Statistical Process Control (SPC) as a Tool of Understanding and Managing Variability
- Learn How to Perform a Risk-Based Impact Assessment
- Conduct a Gap Analysis of Your Existing Change Control Program
- Implement, Maintain, Qualify and Terminate Supplier Quality Agreements
- See First-Hand FDA Quality Metrics Pilot Implementation Case Study
- Ensure Data Integrity Compliance Enterprise-Wide
- Develop Strategies to Revise Quality Policy and Quality Objectives
- Define Risk and Risk Levels —
Implementation of ICH Q9 Quality Risk Management
- Implement Continued Process Verification —
Key Insights to Process Validation Stage 3
- Apply Corrective Action (CAPA) throughout the Product Life Cycle