FDA Inspection Essentials

The inspection management plan should provide for, Response to the arrival of the investigators, Guidance of the inspectors’ activities, Procedure for working with the investigators, and Documentation of the inspection. The management plan or SOP should spell out all of the procedures that you will follow during an investigation. Personnel training is one key variable that should be looked at prior to any inspection. Educate personnel about the inspection process so they can be prepared. Train individuals to interface with FDA investigators. Verify that training has been provided for the personnel on their current job functions, and that supporting records are on file. The goal is to minimize the opportunity for incorrect answers provided to the inspectors, or providing too much information. Have a list of what to do and what not to do when speaking to the inspectors as well.

Why Should You Attend:

You need not dread an FDA inspection if you are adequately prepared. FDA inspections have revealed some trends in recent years. The agency is taking a tougher stand on Quality Systems and using a risk-based approach. Inspectors usually review at least two (2) systems in depth. QA is their number one concern in recent years. They may also look at another system, such as facilities and equipment, materials, production, packaging and labeling or laboratory controls.

FDA does not expect your facility to be perfect. They expect all companies to have some issues. What they really want to see is how you address the problems. The FDA tends to view companies that control these issues to have a high standard of quality. This seminar will help you use the FDA inspection as a learning tool, not as a negative or adversarial experience.

Upon completion of this session, you will learn the proper way to set up for a Regulatory Inspection, ensuring the inspection flows smoothly throughout the duration, and the proper way to speak to inspectors while they are performing the audit.

Learning Objectives:

Upon completion of this session, attendees will:

• Learn Pre-planning and preparation activities
• Know What to do when the investigator arrives
• Know What documents to have ready and on hand
• Develop Assignments and responsibilities for the inspection
• Be Aware of Inspection Do's and Don'ts

Who will Benefit:

• Quality Control Personnel & Management
• Manufacturing Personnel & Management
• Senior Management
• Regulatory Affairs Personnel & Management
• Quality Assurance Personnel & Management