1. Preparing for an FDA Inspection Carmita DePasquale, BSN, RN Safety Review Safety Review

17. WHO WANTS TO PASS THE FDA INSPECTION?

18. LET’S PLAY FDA Inspection Jeopardy Attention: Music is activated when in Slide Show. Answers fly in at the mouse click.

19. 1. Documentation should occur when? a b c d When I get some free time At the time I perform the activity When it does not conflict with my break time Anytime during your shift

20. 2. How do you know how to do your work? a b c d I was trained on the process and I have performed this job many time s I watched Bill do it a couple of times and they let me give it a try Give me one second and I will tell you if I can do it I was trained on the process and I have performed this job many times. Do you want to see

21. 3. Where is the procedure? a b c d Right here in my desk I have access and can read procedures from the area computer I was taught by one of the old-timers who taught me everything I know See this tattoo on my right arm. Did that 2 years ago

22. 4. How do you know that you are using the latest procedure? a b c d Well, it is the only one available in my area I think so. I am not sure this is the right procedure Yes, I just verified it on our computer and with the current SOP I don’t know. My boss tells me what to do, when to Breath, eat, and sleep

23. 5. When were you trained on your SOP? a b c d I didn’t need any training. I knew how when I came here I don’t recall the exact date, I was trained when I first came on the job About 10 years ago Sorry, I am too busy reading this procedure for the first time

24. 6 . When your SOP procedure is revised, are you trained on the revisions? a b c d Yes, we had a formal training session on the revisions two weeks ago Well, sort of. Someone pointed out the changes to the procedure, and I figured it out from there Revised! I have not been trained on the original procedure yet Heck No. We are good here. We just do it and make it happen

25. 7. Is this your password written down on this paper & stuck to the monitor? a b c d Yes! Listen, I have so many Passwords. I just leave it here so I can remember No! My password is always secure No, we were told to take them off the computer till you left No! I use my social security number. …218-56-2311

26. 8. This procedure has been revised, were you trained on the revisions? a b c d Yes, we had a formal training session on the revisions two weeks ago Well, sort of. Someone pointed out the changes to the procedure, and I figured it out from there Not yet. I’m scheduled for the formal training next week Heck No. We are good here. We just do it and make it happen

27. 9. Do you shut down your computer when you go to lunch? a b c d Yes! I secure my computer Shoot No! Why, half the people here can’t read any way No, I just turn off my monitor and people think it is off No, the dot matrix screen is closed by the vertical key lock mode

28. 10. What do you do if the product could be defective? a b c d Keep my mouth shut and keep on trucking Pull out my old procedures and fix it like we use to Contact my supervisor and follow relevant procedures Taste the product and see if the defective product passes our taste test

29. 11. Why are you using that procedure? a b c d Oh, just doing my own thing I am following the procedures for this process. Let me show you I am following the procedures for this process If I do it this way, it makes the pills taste better

30. 12. What will be checked during the inspection? a b c d The type, make and model of employee cars Employee foot smell in reference to water quality in our facility Overall facility, complaints, procedures, reject batches, laboratory controls & computers The cost of eggs in china and the number of eggs consumed in our cafeteria

31. 13. What will the inspectors be looking for? a b c d A free meal in our cafeteria In-Process & finished products, labels, validation process, logbooks and people A date since most of the inspectors travel a lot and have little to no social life A good time

32. 14. How does this inspection relate to our continuous improvement? a b c d Continuous Improvement Process ! Do we have a new product? Continuous WHO Nothing! It means we can go back to our old ways when they leave This inspection assists us in providing the best product to our customer for now and in the future

33. 15. What can I do prior to the inspection? a b c d Plan a vacation and not be here when they arrive Do the same thing I have always done Housekeep, document, follow procedures, know my job, help fellow employees Read a good novel

34. 16. What can I do during the inspection? a b c d Plan a vacation and not be here when they arrive Be confident, listen, avoid bragging, answer question only, and don’t assume Run around shouting , screaming and acting crazy so they will not ask me any questions Go to my usual hiding place and stay there

35. 17. Is “I do not know” an acceptable answer? a b c d Yes only when your significant other asks you to spend money Yes. If you do not know then tell the inspector that you do not know Only if it does not reference the standard size of chocolate chip cookies No. You should know everything

36. 18. How should you answer an inspector’s questions? a b c d With “Yes Sir” or “Yes Ma’am” While standing on one foot Directly and honestly-- do not ramble In French

37. 19. Who can make this inspection a success? a b c d I – YOU – WE – US (TOGETHER) –EVERYONE- Santa Claus Dr. Joan Fallon and Dr. Matthew Heil The employees that stay home the day of the inspection

38. SO, YOU CAN PASS THE “FDA INSPECTION”

39. Wrap-up: Now let’s review the critical elements of GCP/GMP

42. Today is the day in your life for the Opportunity to “make a Difference” in the Success of Our Company