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

🎤  John E. Lincoln‎        |  📅  December 4, 2024   |  🕒  11 AM Eastern Time US

Why You Should Attend: 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.