Planning and performing internal auditsaccording to the GMP

Lecturer: Dr. Orna Dreazen

Date: 25 September, 3 October 2019
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 2 - Day Course
Hours: 09:00 – 17:00
Price: 3,900 NIS + VAT
Credit Points: 2
SKU: 19219
Course Language: Hebrew
About the Course

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.

Who should attend
 Managers and staff from QA, Operations and Laboratories.
Planning and performing internal auditsaccording to the GMP
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       
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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      
About The Lecturer

Dr. Orna Dreazen

Dr. Orna Dreazen, CEO and Chairperson of the Board of Directors
Dr. Orna Dreazen holds a Ph.D in Biochemistry from the Weizmann Institute of Science. She holds a diploma in Business administration from the Tel Aviv University. Dr. Dreazen served in key positions in the Industry as well as in the public service: She was the Quality control manager of Interpharm Laboratories Ltd., established a startup biotech company, Portaman pharmaceuticals Ltd..
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