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

INSPECTION CYCLE PRE-INSPECTION INSPECTION POST-INSPECTION

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

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

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

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

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

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

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

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

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

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

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

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

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

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