Planning and performing internal audits according to the GMPתכנון וביצוע

Conducted by: Dr. Orna Dreazen
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Internal audit is important controls mean 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 make sure they both meet the GMP standard required from them. Internal audits were also made to ensure the organization and its management that major non compliances and malfunctions, so...Continue reading

Internal audit is important controls mean 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 make sure they both meet the GMP standard required from them.
Internal audits were also made to ensure the organization and its management that major non compliances and malfunctions, so they can take necessary corrective and preventive actions, thus ensuring the uncover of a much greater non compliances 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: 
  • 21/12/2021
  • 22/12/2021
  • 28/12/2021
  • 29/12/2021
Course location: Zoom Course
Duration: 4-Days Course
Hours: 09:00 - 12:30
Credits: 2
Course Language: עברית

Course price: ₪3,700 Including VAT
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Issues to be covered

  • The 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

  • Providing the tools for planning an audit, based on risk management
  • Audit performing techniques
  • Collecting and analyzing data
  • Drawing conclusions and planning the corrective actions
  • Testing the corrective actions effectiveness

About The Lecturer

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