FDA Audit - The Do and Don't List


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What your organization should do and should not do during a FDA audit or inspection. For more information go go http://compliance-insight.com/fda-483-warning-letters/fda-483-inspection/

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FDA Audit - The Do and Don't List

  1. 1. Do’s and Don’tsDuring An FDA InspectionCopyrighted 2013 Compliance Insight, Inc.
  2. 2. When dealing with the FDA investigator,we should demonstrate knowledge of andconfidence in our quality system.Not arrogant nor defiant…The DO’s During an InspectionCopyrighted 2013 Compliance Insight, Inc.
  3. 3. * Never give false data, always tellthe truth* Is it OK to say “I don’t know”?* The investigator may ask the samequestion to different people atdifferent timesThe DON’Ts During an InspectionCopyrighted 2013 ComplianceInsight, Inc.
  4. 4. The DON’Ts During an Inspection There are some “tricks”used to pull informationfrom you during theaudit Be aware of what you aresaying and doing The “dome of silence” The tendency of peopleto try to fill a void withmore information Talk, offer more info The “Hmmm… factor” Ask a question, write itdown, shake your head orget a concerned look People take this as a“problem” and then offermore info to fill the gapCopyrighted 2013 ComplianceInsight, Inc.
  5. 5. If the investigator asks you forsome information, do not:* make them ask for it again* wait to see if they forget aboutthe requestThe DON’Ts During an InspectionCopyrighted 2013 ComplianceInsight, Inc.
  6. 6. * It is not productive to argue with the investigatorwhen responding to a question or observation* Don’t challenge the investigator. There is noneed for that. It only motivates curiosity andquestions.The DON’Ts During an InspectionCopyrighted 2013 Compliance Insight, Inc.
  7. 7. * Do not stand around making faces and lookingworried. This makes people feel nervous and mayalert the investigator that something may bewrong.* Act confident and proud, not defensive.* If a fellow employee is being questioned, do not tryto help them by answering the questions yourself orby giving contradictory information.The DON’Ts During an InspectionCopyrighted 2013 Compliance Insight, Inc.
  8. 8. * Do not interrupt the investigator or otheremployees when they are speaking* Do not talk loud or speak with the otherswhen the investigator is trying toconcentrate, read or review documentation.* It is not your job to fill an uncomfortablesilence with additional explanation.The DON’Ts During an InspectionCopyrighted 2013 Compliance Insight, Inc.
  9. 9. The DON’Ts During an InspectionLooselipssinkshipsDon’t talk – even offsite!!! Copyrighted 2013 Compliance Insight, Inc.
  10. 10. Things To RememberDuring An FDA InspectionCopyrighted 2013 Compliance Insight, Inc.
  11. 11. * If it isn’t documented, itdoesn’t existThings to Remember During an AuditCopyrighted 2013 ComplianceInsight, Inc.
  12. 12. * Investigator may“read” your bodylanguage* Be aware of yourbody languageThings to Remember During an AuditCopyrighted 2013 ComplianceInsight, Inc.
  13. 13. * During the inspection,observe and learn to“read” the Investigator’sbody language.Things to Remember During an AuditCopyrighted 2013 ComplianceInsight, Inc.
  14. 14. * Verbal ~7%* Paralinguistic ~38%* Non-Verbal ~55%CommunicationCopyrighted 2013 ComplianceInsight, Inc.
  15. 15. * Intimate zone 0-1½ ft.* Personal zone1½-4 ft.* Social zone 4-12 ft.Interview OrientationCopyrighted 2013 ComplianceInsight, Inc.
  16. 16. * Establish the “normal” behavior patternsSo that you are aware of behavioral changesInterview TechniquesCopyrighted 2013 ComplianceInsight, Inc.
  17. 17. * Upright* Open & Relaxed* Lean forward on occasion* Aligned with Investigator* Casual Posture ChangeTruthful PostureCopyrighted 2013 ComplianceInsight, Inc.
  18. 18. * Retreating* Slouching* Frozen* Not aligned* Barrier Posture* Consistent posture changes* Head & Body SlumpDeceptive PostureCopyrighted 2013 ComplianceInsight, Inc.
  19. 19. * Composed* Concerned/Realistic* Cooperative* Direct/Spontaneous* Open/Helpful* Sincere* Confident* Persistent/ConsistentTruthful BehaviorsCopyrighted 2013 ComplianceInsight, Inc.
  20. 20. * Overly Anxious* Unconcerned/Unrealistic* Uncooperative/Defensive* Guarded/Evasive/Hesitant* Rationalizing/Unhelpful* Insincere* Defeated* Apologetic/Accepting* QuietDeceptive BehaviorsCopyrighted 2013 ComplianceInsight, Inc.
  21. 21. Breaking a GazeRight = edit orfabricateLeft = access memoryI wonder ifhe’llbelievethis?Yes, that ishow it wasdoneAbout 85%accurate butuse only as atool todetermine iffurtherquestionsneed to beCopyrighted 2013 ComplianceInsight, Inc.
  22. 22. * Stick to the facts not opinions. Do not usephrases such as:I think …I’m not sure but …In my opinion, it should …What you are saying is not true…Honestly… Usually… Typically…As I recall…Things to Remember During an AuditCopyrighted 2013 Compliance Insight, Inc.
  23. 23. * Listen to questions carefully* Answer only what is asked. Do not volunteerinformation* Clarify what you don’t understand beforeanswering the question* When a question is too broad, ask for specificsThings to Remember During an AuditCopyrighted 2013 ComplianceInsight, Inc.
  24. 24. * If you don’t know the answer, say so. It is allright to say that you need to look into thesituation further before answering.* Do not guess if you’re not sure of the answer.Look it up in the procedure and or consult youpeers, or another SME.* If you are not a SME for a question asked, do notanswer the question and explain to FDA this factand get the right person.Things to Remember During an AuditCopyrighted 2013 Compliance Insight, Inc.
  25. 25. If you think that the investigator has misunderstoodsomething* say so immediately* explain why in a professional mannerThings to Remember During an AuditCopyrighted 2013 Compliance Insight, Inc.
  26. 26. Phrases to Refrain From!* That’s the way we’ve always done it* Off the record…* I probably shouldn’t say this but…* Who, me?* … Uh, no* It’s probably a mistake.Copyrighted 2013 Compliance Insight, Inc.
  27. 27. * If we would do it that way we would never get anything done* We don’t have enough time or resources to follow that procedure* I do it a different way because the procedure is not good* If you think that’s bad you should see this...* We fixed that problem by firing the person* That’s not my fault, that was the previous supervisor …* That’s not my problem, that’s Quality Assurance’s problem* Write it on the FDA-483, it’s the only way we can correct it.Phrases to Refrain From!Copyrighted 2013 Compliance Insight, Inc.
  28. 28. Documents and RecordsThe investigator is permitted to review : Documents and records pertaining tothe control, manufacturing or qualityassurance activities within the facility,as required by applicable federalregulations. These include (but are not limited to): Procedures Batch Records Regulatory Filings Quality Control Procedures Validation records Calibration/PM records Investigations Other records such as trainingrecords, job descriptions,procedures, promotional labelingetc., as defined in relevant partsof the FDA regulation unlessotherwise specified.Documents that can not be reviewedby FDA: Reports of audits performed byinternal auditors, customers,external auditors or consultants Records and documentspertaining to the financialmatters of the company (salesdata, pricing information, etc.) Research data/protocols (true“research” data is exempt fromreview, product developmentdata can be reviewed by FDA) Personnel records other thantraining Management review meetingminutesCopyrighted 2013 Compliance Insight, Inc.
  29. 29. What happens if an investigator finds something wrong?Answer: Discuss concern/finding with investigator so you fully understandwhat the investigator understands. There should be nomisconceptions. Ask questions. At the end of each day, we request an oral list of all observations.This gives us an opportunity to address issues before the close ofthe inspection and allows us to prepare responses to potential 483observations. At the conclusion of the inspection, the investigator presentssignificant findings at the closing meeting on a FDA 483, List ofObservations. If the findings are minor, the investigator may opt to do nothingexcept verbally advise the Regulatory representative andmanagement of the concerns.Frequently Asked QuestionsCopyrighted 2013 Compliance Insight, Inc.
  30. 30. What happens if an investigator find something wrong?Answer (continued): Your firm will respond in writing to the Form 483 with acorrective action plan. We have to act quickly but effectively. Corrective Action Plan should address specificobservations, systemic correction and time frame forimplementing corrective actions.Frequently Asked QuestionsCopyrighted 2013 Compliance Insight, Inc.
  31. 31. Compliance Insight, Inc.513-860-3512For a Free Consultationwww.Compliance-Insight.comCopyrighted 2013 Compliance Insight, Inc.