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Quality Management and Quality Audit According to GxP/GMP Requirement

Instructor: Eleonora Babayants
Product ID: 705633
  • Duration: 90 Min
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In this webinar, the framework of GxP/GMP regulations, quality management system, and quality audit will be described. Attendees will Learn about different types of quality audits and how to properly prepare for them, what actions you need to take to ensure that your organization will pass an audit.

Why Should You Attend:

GxP/GMP is about Quality Management System (QMS) where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements.

There are few types of quality audits. One of them is GMP audit. GMP audit is very important and critical for an organization in a regulated industry. The preparations for the audit should be done properly before the audit. The primary objective of the audit is to demonstrate the compliance with GxP/GMP regulations. FDA can drop in anytime to perform an unannounced GMP audit or investigation. A GMP audit is conducted to check whether your organization complies with GxP/GMP and to identify if you have full control over your processes, facility, and quality management system (QMS).

What is quality management system? Are you ready for the audit?

Learn about GxP/GMP regulations and how they affect quality management system and quality audit. Learn about different types of quality audits and how to properly prepare for them, what actions you need to take to ensure that your organization will pass an audit.

Areas Covered in the Webinar:

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

Who Will Benefit:

  • Quality Assurance
  • Documentation Managers
  • Records Managers
  • Document Control
  • Compliance
  • Medical Affairs
  • IT
Instructor Profile:
Eleonora Babayants

Eleonora Babayants
Founder and President, Galaxy Consulting

Eleonora Babayants - Founder and President Galaxy Consulting, 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, medical devices, food and beverages companies.

Topic Background:

GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. Quality management system ensures that a product is safe and meets its intended use. Quality audit is the process of systematic inspection of quality management system which is carried out by an internal or external auditor or an audit team.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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