Online Webinar 2019 - 90 Minutes Live Webinar Quality Management and Quality Audit According to GxP/GMP Requirements

Overview
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 is to ensure that a product is safe and meets its intended use.
Quality management system ensures 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 webinar, the framework of GxP/GMP regulations, quality management system, and quality audit will be described.
Session Highlights
GxP/GMP Framework
Quality Management System
Quality Audit
Who Will Benefit
Quality Assurance
Documentation Managers
Records Managers
Document Control
Compliance
Medical Affairs
Why one should 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.
key learning objectives
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).
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.
Instructor Profile
Galaxy Consulting Founder and President Eleonora Babayants 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, knowledge base 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.