San Diego, Ca
San Diego, California

Course Description:
This two day seminar will focus on the FDA inspections and how to prepare the firms for quick, productive and efficient FDA inspections. Instructors will discuss the topics, what to expect during the inspection, how to communicate with the investigators, how to run your front and back rooms during an FDA inspection, how to present documents and records, how to prepare your subject matter experts (SME’s) to respond properly, and how to respond to an FDA 483 or Warning Letter. During the session, participants will be getting real life FDA inspection scenarios and case studies to discuss about how to handle each situation.
Course Objectives:
The course is designed to provide a detailed overview on why FDA conducts inspections and the sanctions available to FDA for those companies who choose not to comply with FDA requirements. This will also give an understanding on the do’s and don’ts during FDA Inspection, choosing the core inspection team, facilitators, Subject Matter Experts (SME’s), runners and scribes. Important topics covered will be:
• How to operate in compliance with FDA requirements.
• What to do when FDA knocks
• How to prepare each group for an inspection: Executive Management/CEO’s, Production area staff and Reception Area staff
• How to handle day by day inspection scenarios
• The roles of front room and back room during FDA inspection
• Steps for responding to 483’s and Warning Letters.

Who will benefit
This seminar will be beneficial to the regulatory personnel in the medical, pharmaceutical, dietary, food and Med Tech industries. This will be valuable for the following regulatory personnel as well:
• Top and Middle Management
• Subject Matter Experts
• Quality Assurance/management
• Compliance Management
• Manufacturing
• Laboratory

Added by complianceonlinecom on November 26, 2012