Journal of Developing Drugs
Open Access

Quality management and quality audit according to GxP/GMP requirements

Joint Event on 8^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR & 8^th International Conference and Exhibition on Pharma Audit, GMP, GCP & Quality Control

June 08-09, 2018 | Philadelphia, USA

Eleonora Babayants

Galaxy Consulting, USA

Keynote: J Develop Drugs

Abstract :

GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations and quality management system is to ensure that a product is safe and meets its intended use. Quality management system has four main components: quality planning, quality assurance, quality control and quality improvement. 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. It is an important part of organization's quality management system and is the major part of GxP/GMP regulations. In this keynote speech, I will describe the framework of GxP/GMP regulations, quality management system, and quality audit.

Biography :

Eleonora Babayants is a Galaxy Consulting Founder and President. She is a Documentation Management Professional and hands-on consulting 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. Her 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 has 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 document templates. Her experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.
Email:eleonora@galaxyconsulting.net