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PREPARATION FOR FDA INSPECTION
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  1. PREPARATION FOR FDA INSPECTION NEMA/ADVAMED/PHILIPS September 25, 2003 Robert L. Turocy

  2. INSPECTION CYCLE • PRE-INSPECTION • INSPECTION • POST-INSPECTION

  3. FDA REQUESTS INSPECTION • TELEPHONE CALL • DATE IDENTIFIED • REQUEST FOR DOCUMENTATION • FACILITY CONTACT

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

  5. PRE-INSPECTION CONT. • GENERATE LOG • TOP PRIORITY • FDA NEEDS • INSPECTION TYPE • INTERPERTER • MOCK INSPECTION

  6. PRE-INSPECTION CONT. • REVIEW QM & POLICY • ACTIVITIES ASSIGNED • ALTERNATES • COMMUNICATION

  7. FDA ACCESS • MEDICAL DEVICE • TRAINING RECORDS • MATERIALS • PACKAGING • LABELING • EQUIPMENT • LOCATION • REGISTRATION & LISTING • FACILITIES

  8. FDA ACCESS cont. • SAMPLES • PRODUCTION RECORDS • CHANGE CONTROL • COMPLAINT FILES • SHIPPING RECORDS • DMR • DHR • MDR AND C&R

  9. REFUSE FDA ACCESS • FINANCIAL DATA • SALES VALUES • PRICING • PERSONNEL DATA • MANAGEMENT REVIEWS • INTERNAL AUDITS • SUPPLIER AUDITS

  10. INSPECTION • OPENING MEETING • REQUEST ID • INTRODUCTION • SCOPE • DAILY MEETINGS • REVIEW FINDINGS & OBSERVATIONS • CHANGES • CORRECTIONS

  11. INSPECTION CONT. • CLOSING MEETING • ATTENDEES • SUMMARY • FDA 483 • CLARIFY ISSUES • IMMEDIATE CA • VERBAL CORRECTION • CA PLAN • MANAGEMENT

  12. POST-INSPECTION • ASSIGNEMENTS • REVISIONS • REPORT TO MGT • IMPLEMENT CA • RESPOND TO FDA • FDA RESPONSE

  13. POST-INSPECTION cont. • FOLLOW-UP • OTHER REGULATORY ACTION • IMPROVEMENT • EIR

  14. 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

  15. INSPECTION DON’Ts • DON’T OVER SPEAK OR SAY IT’S IMPOSSIBLE • DON’T ALLOW RECORDINGS • DON’T SIGN AFFIDAVITS • DON’T ALLOW ACCESS TO FILES • DON’T GUESS AT AN ANSWER • DON’T ANSWER “WHAT IF ?” • DON’T ENGAGE IN ARGUMENT

  16. 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@philips.com