Team Building for an FDA Inspection: Adapted by Mitchell W. Manning Sr. from presentations by former FDA Investigators The Employee Review

Agenda Introduction/Overview What 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 Scenarios Inspection Jeopardy (team competition) Wrap up and questions

Introduction/Overview

What 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 Scenarios

Inspection Jeopardy (team competition)

Wrap up and questions

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?

Why do we need a successful inspection?

Who’s on the inspection team?

What will they look at?

What is our company doing?

Why do we need a successful inspection? Regulatory action Approvals / Contracts Ensures consumer safety Stockholder / Market issues Your professional reputation Freedom from legal problems Stakeholder – You the employee Verify our continuous improvement process

Regulatory action

Approvals / Contracts

Ensures consumer safety

Stockholder / Market issues

Your professional reputation

Freedom from legal problems

Stakeholder – You the employee

Verify our continuous improvement process

Who’s on the inspection team? Chemists Engineers Investigators Microbiologists Computer Specialist Headquarters Reviewer

Chemists

Engineers

Investigators

Microbiologists

Computer Specialist

Headquarters Reviewer

What will they look at? Computers Procedures Complaints Rejected batches Laboratory controls Overall facility Buildings, equipment,materials, cleaning procedures, HVAC, etc.

Computers

Procedures

Complaints

Rejected batches

Laboratory controls

Overall facility

Buildings, equipment,materials, cleaning procedures, HVAC, etc.

What will they look at? (Cont’d) Labels Components In-process materials Validation processes Finished/released materials Logbooks, records and documents Areas not looked at before-Be Ready

Labels

Components

In-process materials

Validation processes

Finished/released materials

Logbooks, records and documents

Areas not looked at before-Be Ready

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.

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.

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.

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.

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.

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.

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!

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!

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.

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.

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.

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.

How do I answer an investigator’s questions? Do’s Don’ts

Do’s

Don’ts

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.

Be prepared.

Be professional.

Provide documents in a timely fashion.

Answer questions directly and honestly.

Recognize“ I Don’t Know” is an acceptable answer.

Don’t Guess or estimate. Volunteer information. Provide any misinformation. Provide misleading information. Show temper or be argumentative.

Guess or estimate.

Volunteer information.

Provide any misinformation.

Provide misleading information.

Show temper or be argumentative.

WHO WANTS TO PASS THE FDA INSPECTION?

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

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? 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? 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

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 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? 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

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? 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

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? 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? 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? 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? 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? 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

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

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? 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? 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? 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? a b c d I – YOU – WE – US (TOGETHER) Santa Claus Bob Smithinson The employees that stay home the day of the inspection

SO, YOU CAN PASS THE “FDA INSPECTION”

Wrap-up: Now let’s review the critical elements of cGMP

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

Be clean.

Know your job.

Control for quality.

Write your procedures.

Follow your procedures.

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.

Maintain your area equipment.

Audit your work for compliance.

Document your work processes when performed.

Good people like you with high personal character.

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

STAND UP IF WE CAN DO THAT

STAND UP IF

WE CAN DO THAT