An employee training program on the FDA Inspection process.

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

2. 2
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

3. 3
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?

4. 4
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

5. 5
Who’s on the inspection
team?
Chemists
Engineers
Investigators
Microbiologists
Computer Specialist
Headquarters Reviewer

6. 6
What will they look at?
Computers
Procedures
Complaints
Rejected batches
Laboratory controls
Overall facility
 Buildings, equipment,materials, cleaning
procedures, HVAC, etc.

7. 7
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

8. 8
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.

9. 9
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.

10. 10
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.

11. 11
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!

12. 12
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.

13. 13
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.

14. 14
How do I answer an
investigator’s questions?
Do’s
Don’ts

15. 15
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.

16. 16
Don’t
Guess or estimate.
Volunteer information.
Provide any misinformation.
Provide misleading information.
Show temper or be argumentative.

17. 17
WHO WANTS
TO
PASS THE FDA
INSPECTION?

18. 18
LET’S PLAY
FDA Inspection
JeopardyAttention: 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 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

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
I don’t know. My supv.
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 “Sir Yes Sir”
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)
Santa Claus Bob Smithinson
The employees that stay
home the day of the
inspection

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

39. 39
Wrap-up:
Now let’s review the critical
elements of cGMP

40. 40
CGMP Critical Elements
Be clean.
Know your job.
Control for quality.
Write your procedures.
Follow your procedures.

41. 41
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.

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

43. 43
STAND UP IF
WE CAN DO
THAT