Today was the first day of the GMP FACT inspection. Therefore, I was in the North Pavilion building for most of the day. Throughout the day, the inspector would go through the lab, making notes of what the lab did or didn’t do correctly and evaluating the various documents that a lab is required to have. The day started off with a general introduction of the lab, which Dr. K presented and an overview of the staff associated with the lab. They then moved on to the storage units where they keep supplies used in the lab and made sure that labels were correct, as well as whether the temperatures and humidities were fine for each room. In the room with the liquid nitrogen tanks, the inspector made sure that the safety of the workers was handled well and that the FDA had approved the tanks for use. They then moved on to the sterile part of the lab, which I did not participate in.
I instead went with Dr. K to visit radiology in the main hospital. There, we reviewed a patient’s MRI from the day before because there had been some inconsistencies. I was able to learn the different ways the readers could manipulate the images so that they could get a clear picture of every part of the brain. After I got back, I learned the process of which charts are filed in the office. One of the assistants of Dr. K showed me how to write letters to the patient informing them of their next appointment and how to update patients’ charts online. I then was able to attend a Skype meeting with a patient who had recently developed strange symptoms. I listened in on what the family’s pediatrician could do to help the child and how the family should monitor the child. To wrap up my day, I attended a meeting discussing the details of the current clinical trial.