Avoid Warning Letters in View of the U.S. FDA's Stated Goal 2015

Avoid Warning Letters in View of the U.S. FDA's Stated Goal 2015 is an event that provides knowledge on avoid warning letters in view of the US FDA`s stated goal.

Key Topics

• Proactive reviews of the applicable U.S. FDA / cGMP requirements
• The U.S. FDA`s new aggressive implementation plans
• FDA Inspectional Objectives
• Key areas to focus limited resources
• Recent trends and events
• Common areas for critical mistakes
• Q&A
• The compliance audit

Who should Attend

• Regulatory Affairs
• Senior Management, Project Leaders
• Internal and Supplier Auditor Personnel
• Quality Systems Personnel
• CAPA and P&PC personnel desiring to optimize systems and responses in harmony with the U.S. FDA`s quality management systems / cGMP expectations
• R&D and Engineering Staff