Quality Management and Quality Audit According to GxP/GMP Requirements

All industries regulated by the FDA such as food, pharmaceutical, medical devices and cosmetics are required to follow GxP/GMP regulations. These regulations are intended to ensure that product safety and its intended use to its end user remain intact. The quality management system (QMS) for production and testing of products in these regulated industries are defined in the GxP/GMP regulations. Quality management system has four key constituents: quality planning, quality assurance, quality control, and quality improvement. A systematic inspection of any quality management system carried out by an internal or external auditor or an audit team is termed a Quality audit. Quality audits are an integral part of organization’s quality management system. We will focus on all 3 types of audit – internal, external and GMP audit. GMP audit is very important and critical for an organization to prove their documentation, process, training and reports follows the decided quality standards. Preparation for an audit should be done with due diligence in advance so that you are not caught off guard during the inspection.

Why You Should Attend:

In this webinar, an overview of GxP/GMP regulations, quality management system, and quality audit will be covered. You will take away knowledge of GxP/GMP regulations and their effect on quality management systems including the quality audit. This webinar will also provide you with insight on the different types of quality audits and how to properly prepare for them. We will also examine from industry best practices the actions you need to take to ensure that your organization will pass an audit.

Areas Covered in the Session :

  • GxP/GMP Framework
  • GxP/GMP Requirements
  • Quality Management System
  • Quality Audit

Who Should Attend:

  • Quality Assurance Departments
  • Compliance Departments
  • Documentation Departments
  • IT Departments
  • Records Managers
  • Document Control Personnel
  • Medical Affairs Personnel

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Eleonora Babayants

Eleonora Babayants is a Galaxy Consulting Founder and President, She is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management. Eleonora’s past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs.

She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users’ requirements.

She wrote technical documents and created documents templates. Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance