🎤  John E. Lincoln‎        |  ðŸ“…  January 10, 2025   |  ðŸ•’  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.
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