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

בהדרכת: גב' קרן גינסבורי

מק"ט: 22137

גרסה להדפסה

נווט אותי לשם

מקוון - בזום

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

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.

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

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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.