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

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Presentation on theme: "PREPARATION FOR FDA INSPECTION NEMA/ADVAMED/PHILIPS September 25, 2003 Robert L. Turocy."— Presentation transcript:

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

2 2 INSPECTION CYCLE  PRE-INSPECTION  INSPECTION  POST-INSPECTION

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

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

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

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

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

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

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

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

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

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

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

14 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 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 16 REFERENCES 21 CFR 820, Preamble & Regulation INSP. DEVICE MFGRS. CP FDA QSIT HANDBOOK GUIDE ADVAMED POINTS TO CONSIDER MGMT, DESIGN, & CAPA

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