Preparing for an FDA Inspection

Adapted by Mitchell W. Manning Sr. from presentations by former FDA Investigators

Employee Review

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Agenda

Introduction/OverviewWhat can I do prior to the inspection?What can I do during the inspection?How do I answer an investigator’s questions?Role Play and Experience ScenariosInspection Jeopardy (team competition)Wrap up and questions

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Introduction/Overview

Why do we need a successful inspection?Who’s on the inspection team?What will they look at?What is our company doing?

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Why do we need a successful inspection?

Regulatory actionApprovals / ContractsEnsures consumer safetyStockholder / Market issuesYour professional reputationFreedom from legal problemsStakeholder – You the employeeVerify our continuous improvement process

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Who’s on the inspection team?

ChemistsEngineersInvestigatorsMicrobiologistsComputer SpecialistHeadquarters Reviewer

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What will they look at?ComputersProceduresComplaintsRejected batchesLaboratory controlsOverall facility Buildings, equipment,materials,

cleaning procedures, HVAC, etc.

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What will they look at? (Cont’d)

LabelsComponentsIn-process materialsValidation processesFinished/released materialsLogbooks, records and documentsAreas not looked at before-Be Ready

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What is Our Company doing?

Counting heavily on your performance.Providing extensive cGMP training to all employees.Using extensive resources internally and from outside sources.Taking broad steps to elevate the importance of the expected FDA inspection.

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What is Our Company doing? (cont’d)

Identifying inspection coordinators.Developing an inspection response plan.Establishing communication procedures.Designating key personnel responsibilities.Establishing written policies--photos; recordings; etc.Enhancing our continuous improvement process.

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What can I do prior to the inspection?

Support preparation efforts.Ensure your work area is neat and orderly.Ensure your area equipment and instruments are clean and calibrated.Ensure your logs and production documents are filled out completely, accurately and legibly at time of performance.

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What can I do prior to the inspection? (Cont’d)

Be prepared.Know your job.Encourage your fellow workers.Expect high quality in all your work-accept nothing less.Remember: First impressions are lasting Impressions; Employees, facilities and documents make a lasting impression with the FDA!

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What can I do during the inspection?

Listen carefully to questions.Don’t assume you know the question.Answer only after the question is fully stated.Be confident of your answer. If you don’t know, say so.Avoid bragging about your area.

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What can I do during the inspection? (cont’d)

Don’t be nervous.Re-review all your procedures.Provide only what is asked for.Don’t leave documents out on your desk.Keep your area clean. Be ready any day!Be proud of your area but the best of things are left unseen.

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How do I answer an investigator’s questions?

Do’s

Don’ts

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Do

Be prepared.Be professional.Provide documents in a timely fashion.Answer questions directly and honestly.Recognize“ I Don’t Know” is an acceptable answer.

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Don’tGuess or estimate.Volunteer information.Provide any misinformation.Provide misleading information.Show temper or be argumentative.

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WHO WANTS TO PASS THE FDA INSPECTION?

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LET’S PLAY

FDA Inspection JeopardyAttention: Music is activated when in Slide Show.Answers fly in at the mouse click.

1. Documentation should occur when? 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

2. How do you know how to do your work? 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 times

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

3. Where is the procedure? 3. Where is the procedure?

a b

c d

Right here in my deskI 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

4. How do you know that you are using the latest procedure?

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 onour computer

I don’t know. My supv.tells me what to do, when to Breath, eat, and sleep

5. When were you trained on your SOP? 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 agoSorry, I am too busy

reading this procedure for the first time

6. When your SOP procedure is revised, are you trained on the revisions?

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

7. Is this your password written down on this paper & stuck to the monitor?

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 ithere 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

8. This procedure has been revised, were you trained on the revisions?

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

9. Do you shut down your computer when you go to lunch?

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

10. What do you do if the product could be defective? 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

11. Why are you using that procedure? 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

12. What will be checked during the inspection? 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

13. What will the inspectors be looking for? 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 lifeA good time

14. How does this inspection relate to our continuous improvement?

14. How does this inspection relate to our continuous improvement?

a b

c d

Continuous Improvement Process !

Do we have a new product?

Continuous WHONothing! 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

15. What can I do prior to the inspection? 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

16. What can I do during the inspection? 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

17. Is “I do not know” an acceptable answer? 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

18. How should you answer an inspector’s questions? 18. How should you answer an inspector’s questions?

a b

c d

With “Sir Yes Sir”

While standing on one foot Directly and honestly-- do not

ramble

In French

19. Who can make this inspection a success? 19. Who can make this inspection a success?

a b

c d

I – YOU – WE – US(TOGETHER)

Santa Claus Bob Smithinson

The employees that stay home the day of the

inspection

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SO, YOU CAN PASS THE “FDA INSPECTION”

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Wrap-up:

Now let’s review the critical elements of cGMP

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CGMP Critical Elements

Be clean.Know your job.Control for quality.Write your procedures.Follow your procedures.

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CGMP Critical Elements

Maintain your area equipment.Audit your work for compliance.Document your work processes when performed.Good people like you with high personal character.

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Today is the first day of your Opportunity to “make a Difference” in the Success of Our Company

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STAND UP IFWE CAN DO THAT