Planning and performing internal audits according to the GMPתכנון וביצוע

Expert Lecturer: Dr. Orna Dreazen
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אינדיקטור
Internal audits are important means of control every organization/laboratory’s management should have in its hands. Their role is to inspect the managing system and the professional work, in order to ensure they both meet the GMP standard required of them. Furthermore, Internal audits are an additional risk management mechanism put in place early on in order to identify non compliances...Continue reading

Internal audits are important means of control every organization/laboratory’s management should have in its hands. Their role is to inspect the managing system and the professional work, in order to ensure they both meet the GMP standard required of them.

Furthermore, Internal audits are an additional risk management mechanism put in place early on in order to identify non compliances and malfunctions. This process allows the organization the opportunity to take necessary corrective and preventive actions, thus minimizing the probability of much greater non compliances occuring or being uncovered by external auditors and putting any pending marketing approval at risk.
A qualified internal auditor can also perform other audits, both inside and outside the organization.

Throughout the course, we shall be discussing the various components of planning an audit based on risk management, performing an audit and drawing conclusions from internal audits. We shall also discuss the evaluation of the effectiveness of the corrective measures implemented by the organization.

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Dates: 
  • 11/06/2025
  • 12/06/2025

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    Course location: Hybrid: Virtual & Scientific Park Nes Tziona Kiryat Weizmann
    Duration: 2-Day Course
    Hours: 09:00 - 17:00
    Credits: 2
    Course Language: עברית

    Course price: 4,950 NIS + VAT
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    Issues to be covered

    • A pro-active approach to quality
    • Collecting and analyzing data for the planning of audits, based on risk management
    • The behavior and characterization of the audit conductor
    • Handling objections
    • Performing audits
    • Reporting audit results and implementation of corrective actions
    • Evaluating effectiveness of the corrective actions

    Who should attend

    Managers and staff from QA, Operations and Laboratories.

    Benefits to the Participants

    Participants will walk away with :

    • The tools for planning an audit, based on risk management
    • Techniques to perform audits
    • Knowledge on how to collect and analyze data
    • The ability to plan, test and draw conclusions from corrective actions.

    About The Lecturer

    Orna Dreazen
    CEO and Chairperson of the Board of Directors at Nextar.
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