חדש

ניהול תחקירים אפקטיביים בתעשייה הפרמצבטיתConducting Effective Investigations

בהדרכת: גב' קרן גינסבורי
מק"ט: 231097
גרסה להדפסה

שתף קולגה:

Almost every regulatory inspection starts with a pre-inspection request for a list of non-conformances: deviations, OOS results, changes, incidents, non-conforming product, returns, recalls, complaints… this list is long

If it is agreed that the primary purpose of a Quality Management System is to #PREVENT unwanted, undesirable, unexpected events, then any non-conformance is of concern.

...המשך קריאה

Almost every regulatory inspection starts with a pre-inspection request for a list of non-conformances: deviations, OOS results, changes, incidents, non-conforming product, returns, recalls, complaints… this list is long

If it is agreed that the primary purpose of a Quality Management System is to #PREVENT unwanted, undesirable, unexpected events, then any non-conformance is of concern.

Some events are self-explanatory.  Others present a mystery which needs to be investigated, understood and fixed.

This course will present a toolbox for conducting effective investigations when needed, and for documenting the same with the purpose of #PREVENTING unwanted events from happening again and ensuring product quality.

סגור
תאריך:  5 יולי, 2023
מיקום הקורס: כפר המכביה, רמת גן
משך הפעילות: יום עיון
שעות: 17:00 - 09:00
נקודות זכות: 1
שפת הקורס: עברית

עלות הקורס: ₪2,300 + מע"מ
יש לך מנוי? מגיעה לך הנחה נוספת!

יש לך שאלה? יש לנו את כל התשובות

מה תכני הקורס?

  • What is a non-conforming event: deviation, OOS, Complaint, or any other identified deficiency in a quality system
  • PREVENTION
  • Correction
  • Corrective Action
  • Investigations:
    • when are they NOT needed
    • how to conduct an investigation
    • how to document an investigation
    • conclusions as opposed to findings (facts)
    • Communication
    • Change management for Corrective Action
  • Escalation process and management involvement (SOP) for resolving tough issues

למי זה מתאים?

VP Operations, Production Managers, Quality Unit Directors, VP Quality, VP QA / RA, Quality Unit Supervisors, RA personnel, personnel involved in product development, Operations and Production personnel and Supervisors, Laboratory personnel and any other person involved directly or indirectly in compliance and quality related activities.

מה אקבל מכך בפועל?

  • Understand which type of events require investigation
  • Differentiate between investigation of:
    • Product Impact
    • Cause(s) of the event to eliminate the cause and ensure it does not recur
  • Learn how to document the investigation effectively
  • Monitoring effectiveness
  • Communication of findings, lessons learne
  • Change control for corrective actions

מי מעביר את הקורס?

קרן גינסבורי
קרן גינסבורי, M. Sc. B. Pharm. MR PharmS – בעלת
קרא עוד

הוספת תגובה

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