Thread by @SQAHeadquarters

Next up is "Return of Surveillance Inspection" with Eric Pittman. Starting now.

#SQA2022

#sqa2022

GCP inspections will be announced, but GLP inspections will be unannounced once the public health emergency is lifted.

#sqa2022

We are not going to cite you from anything on a guidance document -- only regulations #sqa2022

Duh dum. #sqa2022. We didn't stop inspections.

It's important for people to know what hte FDA knows. #sqa2022

The FDA inspect these things. #sqa2022

We also do inspections at Ports of Entry. #sqa2022

The 3 types of inspection. #sqa2022

During the public health emergency we were out doing inspections. We were focused on COVID. IN 2020/2021, we were doing mission critical inspections. #sqa2022

BIMO did more inspections (408) than rest of FDA put together. Here are the stats. #sqa2022

In July 2021, were able to start some surveillance inspections if the "stars lined up." Which changed on 29 December thanks to Delta and Omnicron. #sqa2022

They are back. #sqa2022

Foreign inspections are back - they are on a voluntary basis. #sqa2022

8 foreign inspections have been scheduled. #sqa2022

What can you expect? #sqa2022

All 10 foreign inspectors are back on lin. #sqa2022

on **line.

Make sure you're doing internal audits. Have you been conducting training ... and training on the why? Are docs up to date? #sqa2022

When was the last time you did a mock inspection? #sqa2022

Look at past warning letters. #sqa2022

Section 3 the most important. #sqa2022

Written responses should be clear, concise, compelling and complete (CAPA, CAPA) #sqa2022

Questions for Eric.
Q: If a system is validated but a known gap, would you see this called out in each GLP study?
A: Yes, but it depends.

Q: Who do you contact to talk to for an inspection.
A:The most responsible person at the facility. If no luck, I will call corporate.

BTW 15 days is 15 BUSINESS DAYS. #sqa2022

Q: Will you still be doing remote monitoring?
A: Yes but won't be used as much.

Thank you again to Eric Pittman.

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