Avoid Warning Letters in View of the U.S. FDA's Stated Goal
🎤 John E. Lincoln‎ | 📅 December 4, 2024 | 🕒 11 AM Eastern Time US
Description:
This webinar focuses on the critical steps to avoid U.S. FDA warning letters by understanding the agency's latest aggressive enforcement plans. Learn how to navigate evolving FDA/cGMP regulations, prioritize limited resources, and tackle common inspection pitfalls. Gain valuable insights into recent trends, compliance audits, and FDA inspection objectives to ensure your company is audit-ready. Attendees will understand the most common mistakes that lead to non-compliance and how to proactively stay ahead of regulatory challenges. Equip yourself with the knowledge to safeguard your operations and prevent costly enforcement actions.
Areas Covered in the Session:
- The U.S. FDA's new aggressive implementation plans
- Proactive reviews of the applicable U.S. FDA / cGMP requirements
- Key areas to focus limited resources
- FDA Inspectional Objectives
- Common areas for critical mistakes
- Recent trends and events
- The compliance audit
- Q&A
Who Should Attend:
- Quality Assurance Departments
- Regulatory Affairs Departments
- Research and Development Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Internal and Supplier Auditors
- CAPA and P&PC personnel desiring to optimize systems and responses in harmony with the U.S. FDA's quality management systems / cGMP expectations.
