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BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING Willis Ennis Director QA/RA

BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING Willis Ennis Director QA/RA. BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING. THE PROCESS THE PITFALLS. Definition of Audit. INSPECTION TO AN APPLICABLE STANDARD. PREPARATION FOR THE AUDIT PROCESS. PURPOSE OF THE AUDIT

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BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING Willis Ennis Director QA/RA

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  1. BEST PRACTICES IN INTERNAL COMPLIANCE AUDITINGWillis Ennis Director QA/RA

  2. BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING • THE PROCESS • THE PITFALLS

  3. Definition of Audit • INSPECTION TO AN APPLICABLE STANDARD

  4. PREPARATION FOR THE AUDIT PROCESS • PURPOSE OF THE AUDIT • DEFINE THE SCOPE OF THE AUDIT • DETERMINE RESOURCES • AUTHORITY FOR THE AUDIT

  5. PREPARATION FOR THE AUDIT PROCESS • IDENTIFY PERFORMANCE STANDARDS • NOTIFY AUDITEE • CHECKLIST • REVIEW PREVIOUS AUDITS

  6. PURPOSE • MEANS OF OBJECTIVE FEEDBACK TO MANAGEMENT • CONTINUOUS IMPROVEMENT • REGULATORY RISK ASSESSMENT

  7. SCOPE • DEFINE THE FOCUS OF THE AUDIT • CBER/CDER/CDRH • EU/EMEA • ISO/SIX SIGMA • INTERNAL SOPs • CUSTOMER’S EXPECTATIONS

  8. RESOURCES • QA • QC - TECHNICAL RESOURCE • AREA SUPERVISOR • OTHER?

  9. NOTIFICATION • SCHEDULE SOME TIME • MINIMIZE DISTRACTIONS • DON’T SURPRISE THEM (WHO DO YOU THINK YOU ARE THE FDA?)

  10. PERFORMANCE STANDARDS • SOPs • POLICIES • PROCEDURES • DOCUMENTS • DRAWINGS

  11. REVIEW • PREVIOUS INTERNAL AUDITS • CAPAs • DEVIATIONS • CHANGE CONTROLS • FDA INSPECTION TRENDS • CUSTOMER OBSERVATIONS

  12. CHECKLIST • PROS • ORGANIZED • FOCUSED • CONSISTENT • CONS • CONSTRAINING • CHECK THE BOX • NOT ALWAYS APPLICABLE

  13. NOTIFICATION OF AUDITEE • MAKE SURE THEY ARE READY… • RESOURCES ARE IN PLACE • DELAY IF REASONABLE BUT IF THE DOG ATE THE HOMEWORK… • INCLUDE AGENDA WITH NOTIFICATION

  14. AUTHORITY • MEDICAL DEVICE QUALITY SYSTEM REGULATION 820.XXX • PLANNED AND PERIODIC AUDITS • INTERNAL SOPs • ISO • INDUSTRY EXPECTATION

  15. FREQUENCY • ROUTINE • ANNUAL, BI-ANNUAL • AUDIT SCHEDULE BASED ON CRITICALITY AND RESOURCES • PROBLEM / FOR CAUSE… STERILITY ISSUE, NON-CONFORMANCE

  16. AGENDA • MEET WITH LAB HEAD OR AREA SUPERVISOR • DEFINE SCOPE • DEFINE LENGTH OF AUDIT • DEFINE CRITICAL LAB OR MANUFACTURING PERSONNEL NEEDED TO PARTICIPATE DURING AUDIT

  17. AGENDA • LABORATORY / TESTING / QC • MANUFACTURING

  18. TYPES OF AUDITS • PROCESS • GAP ANALYSIS • ASSESS INDIVIDUAL SYSTEMS • TOP DOWN • BOTTOM UP

  19. CAPAWHAT IS YOUR INTENTION • WHAT’S THE RECORD FOR THE MOST CAPAs... TOO MANY • PUMMEL MANUFACTURING INTO COMPLIANCE… WAY TOO MANY • BUILD A ROADMAP FOR IMPROVEMENT… THAT’S BETTER • FIND LOW HANGING FRUIT… TELL SENIOR MANAGEMENT YOU’LL SAVE THEM SOME MONEY $$

  20. WHAT YOU DON’T WANT TO HAVE HAPPEN.. • YOUR CAPA SYTEM IS OVERLOADED… CONGRATULATIONS! YOU HAVE THE RECORD, NOW WHAT? • MANUFACTURING IS OVERBURDENED, SO IS QA • CAPA IS NO LONGER EFFECTIVE • YOUR CAPA IS CRAPA…

  21. BUM$$ • BIG UGLY MULTI-FACETED EXPENSIVE $$$ • LONG RESOLUTION TIME, NEED CAPITOL APPROVAL • LONG TERM PROJECTS ARE WORTHWHILE, NECESSARY AND IMPORTANT • BUT DON’T LET THEM DISCOURAGE, DILUTE THE FOCUS

  22. TAKE SMALL STEPS • START THE WHEEL TURNING • IDENTIFY AND RESOLVE • MAKE MINOR CHANGES TO SOPs PROCESS IMPROVEMENTS

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