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.
The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control.
Many times, the arrival of a Regulatory Investigator is a daunting experience for some. This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol for setting up the Inspection room and any associated “war” rooms that will support the inspection, and how to manage requests from the investigators in a timely and accurate manner. This preparation minimizes stress and disorder during the inspections.
Working in a highly regulated industry, we know our firms need to be “inspection-ready” at all times. This is not only to maintain a good rapport with the Regulators, but also as a commitment to quality for our customers, the patients who use our products.
Regulatory inspections should be a time to demonstrate the high level of compliance your firm has to the regulations, and to customer safety and quality. The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report.
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.
DAY 01(10:00 AM - 3:00 PM EDT)
FDA Inspections 101
- Unannounced FDA visits – how to prepare and react
- Preparing for FDA audits / PAI preparation – what training should look like for key players
- Basic concepts that should be employed by everyone regulated by the FDA – review of quarterly quality topics to keep current
- How a company can prepare for situations like this – training of SMEs and beyond
- How a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business
DAY 02(10:00 AM - 3:00 PM EDT)
Observations and Lessons Learned
- How should a company respond to 483 observations or a warning letter – deadlines, tracking, and closures
- Lesson learned – reviews of the observations and overall inspection experience
Real Life Situations
- Case Scenarios – review of real-life scenarios that you could encounter during inspections
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