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Feelings you may feel

You may want to Panic!!

There's no reason to

be scared

Or you may be confused...

Or Lane's personal favorite:

"FUDGE!! the FDA is here"

FDA investigators are trained to:

  • Be your friend
  • Ask you direct questions
  • Sympathize with you
  • Give you the uncomfortable '7 sec look'
  • Ask the same question different ways or to different people

Do These:

  • Maintain Good Housekeeping
  • Know where SOPs are located (hard and electronic copies)
  • Be cooperative and polite
  • Be confident and professional
  • Understand the WHOLE question before anwersing
  • Give honest and accurate answers
  • Answer what was asked, nothing more
  • Avoid words such as "never" or "always"
  • Take IMMEDIATE action on items discovered or requests
  • Listen to QA prior to tour and fix STAT

Don't do these:

  • Answer questions that you don't know the answer to or is outside of your area
  • Answer questions without 'refreshing your memory' or speaking to your supervisor/QA
  • Guess
  • Entertain hypothetical questions
  • Solicit opinions
  • Make excuses for findings
  • Delay with requests (10 min rule)
  • Sign anything
  • Allow into areas without QA and or Senior Management
  • Challenge the investigators
  • Give the investigators copies of anything; Give to QA first for review

Documents of potential importance:

  • Equipment (inventory list, SOPs, manuals, maintenance and calibration records)
  • How employees are trained
  • Test and Control Articles (characterization data; DFA/stability results; reserve sampling)

Finally, the day ends, now what?

  • QA will ask about open items/issues
  • try to get a preview of tomorrow
  • review any documents requested for the following day

Together, as a team, we can accomplish this audit

F.D.A. Readiness

?

Any questions?!?!?!?

Asking for stuff:

  • QA management calls me
  • "Fudge"
  • Quickly finds someone to help (defined: not actively in the laboratory so please drop what you are doing and help me :)
  • 10 minute rule: get material to QA STAT for review
  • Repeat process as needed
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