ניהול שינויים, חריגות, תחקירים וCAPA לאור ההנחיות החדשות של PIC/s

בהדרכת: גב' קרן גינסבורי
מק"ט: 22137
גרסה להדפסה

שתף קולגה:

Corrective and Preventive Action (CAPA), is a “well-known pharmaceutical concept” according to FDA’s quality systems guidance (2006). Actually the concept, while well-known in the medical device industry and through ISO certification systems, has been notably missed in pharmaceutical GMPs to-date.  The recently issued ICH Q10 guidance, addresses four specific pharmaceutical quality system elements that augment GMPs to...המשך קריאה

Corrective and Preventive Action (CAPA), is a “well-known pharmaceutical concept” according to FDA’s quality systems guidance (2006). Actually the concept, while well-known in the medical device industry and through ISO certification systems, has been notably missed in pharmaceutical GMPs to-date.  The recently issued ICH Q10 guidance, addresses four specific pharmaceutical quality system elements that augment GMPs to achieve the objectives of a modern, successful and effective quality system.
This course will look at what CAPA really is, how information is gathered and fed into the system and how issues are investigated to address root cause and resolve the issue, preventing recurrence.
This course will help your company develop an escalation policy (addressed in Q10) to take unresolved items through the management hierarchy to ensure resolution.

סגור
תאריכים: 
  • 19/01/2022
  • 26/01/2022
מיקום הקורס: הקורס יועבר באמצעות Zoom
משך הפעילות: יום עיון מפוצל לשני מפגשי Zoom
שעות: 13:30 - 10:00
נקודות זכות: 1
שפת הקורס: עברית

עלות הקורס: ₪1,800 + מע"מ
ההרשמה המוזלת נסגרה
יש לך מנוי? מגיעה לך הנחה נוספת!

יש לך שאלה? יש לנו את כל התשובות

מה תכני הקורס?

  • CAPA and its roots in ISO
  • ICH Q10 – Pharmaceutical Quality System: the need for enhancing GMP with a global guidance
  • CAPA = 25% of a quality system
  • What constitutes a deviation or identified deficiency in a quality system
  • Corrective Action
  • Preventive Action
  • Investigations:
    • when are they NOT needed
    • how to conduct an investigation
    • how to document an investigation
    • conclusions as opposed to findings (facts)
  • Managing a CAPA system: manual vs computerized (part 11 compliance?)
  • Escalation process (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?

  • Understanding how a CAPA system forms one of the four pillars of a quality system and how to conduct effective investigations of defects and deficiencies in the quality system.
  • A clear understanding of the difference between corrective as opposed to preventive actions will be achieved.

מי מעביר את הקורס?

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

הוספת תגובה

[contact-form-7 404 "לא נמצא"]