PREPARATION FOR FDA INSPECTION

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PREPARATION FOR FDA INSPECTION

• NEMA/ADVAMED/PHILIPS
• September 25, 2003
• Robert L. Turocy

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INSPECTION CYCLE

• PRE-INSPECTION
• INSPECTION
• POST-INSPECTION

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FDA REQUESTS INSPECTION

• TELEPHONE CALL
• DATE IDENTIFIED
• REQUEST FOR DOCUMENTATION
• FACILITY CONTACT

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PRE-INSPECTION

• PLAN INSPECTION, OBJECTIVES
• ASSIGN COORDINATOR
• INSPECTION SCOPE REGULATIONS
• REVIEW PROCEDURES
• REVIEW PAST INSPECTIONS
• DOCUMENTATION SUPPLIED
• SCHEDULING, PERSONNEL, FACILITIES PREPARATION
• TRAINING

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PRE-INSPECTION CONT.

• GENERATE LOG
• TOP PRIORITY
• FDA NEEDS
• INSPECTION TYPE
• INTERPERTER
• MOCK INSPECTION

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PRE-INSPECTION CONT.

• REVIEW QM POLICY
• ACTIVITIES ASSIGNED
• ALTERNATES
• COMMUNICATION

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FDA ACCESS

• MEDICAL DEVICE
• TRAINING RECORDS
• MATERIALS
• PACKAGING
• LABELING
• EQUIPMENT
• LOCATION
• REGISTRATION LISTING
• FACILITIES

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FDA ACCESS cont.

• SAMPLES
• PRODUCTION RECORDS
• CHANGE CONTROL
• COMPLAINT FILES
• SHIPPING RECORDS
• DMR
• DHR
• MDR AND CR

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REFUSE FDA ACCESS

• FINANCIAL DATA
• SALES VALUES
• PRICING
• PERSONNEL DATA
• MANAGEMENT REVIEWS
• INTERNAL AUDITS
• SUPPLIER AUDITS

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INSPECTION

• OPENING MEETING
• REQUEST ID
• INTRODUCTION
• SCOPE
• DAILY MEETINGS
• REVIEW FINDINGS OBSERVATIONS
• CHANGES
• CORRECTIONS

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INSPECTION CONT.

• CLOSING MEETING
• ATTENDEES
• SUMMARY
• FDA 483
• CLARIFY ISSUES
• IMMEDIATE CA
• VERBAL CORRECTION
• CA PLAN
• MANAGEMENT

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POST-INSPECTION

• ASSIGNEMENTS
• REVISIONS
• REPORT TO MGT
• IMPLEMENT CA
• RESPOND TO FDA
• FDA RESPONSE

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POST-INSPECTION cont.

• FOLLOW-UP
• OTHER REGULATORY ACTION
• IMPROVEMENT
• EIR

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INSPECTION DOs

• DO PLAN FOR INSPECTION
• DO PROVIDE REVELANT DOCUMENTATION
• DO ANSWER QUESTIONS TO SPECIFIC ACTIVITY
• DO ESCORT THE INSPECTOR
• DO TAKE NOTES
• DO COPY DOCUMENTS REMOVED
• DO STAMP THE REMOVE DOCUMENTS
• DO COOPERATE WITH THE FDA
• BE POLITE BUT FIRM WITH YOUR RIGHTS

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INSPECTION DONTs

• DONT OVER SPEAK OR SAY ITS IMPOSSIBLE
• DONT ALLOW RECORDINGS
• DONT SIGN AFFIDAVITS
• DONT ALLOW ACCESS TO FILES
• DONT GUESS AT AN ANSWER
• DONT ANSWER WHAT IF ?
• DONT ENGAGE IN ARGUMENT

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REFERENCES

• 21 CFR 820, Preamble Regulation
• http//www.fda.gov/cdrh/dsma/cgmphome.html
• INSP. DEVICE MFGRS. CP 7382.845
• FDA QSIT HANDBOOK GUIDE
• ADVAMED POINTS TO CONSIDER MGMT, DESIGN, CAPA
  http//www.advamed.org/mtli/points
• robert.turocy_at_philips.com

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