Avoid Warning Letters in View of the U.S. FDA's Stated Goal

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.