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FDA readiness
Transcript
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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