Quality Management and Quality Audit According to Gxp/GMP Requirements
Complete Guide to Learn GxP/GMP Regulations How They Affect Quality Management System and Quality Audit. Get Audit Ready Today!
Instructor :
Eleonora Babayants
Webinar ID:
2298
Date: FEB 18, 2025 (TUE)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins
What you will learn
- What is Quality Management System?
- How to Know if You Ready for the Audit?
- Learn about GxP/GMP Regulations
- How Regulations Affect Quality Management System and Quality Audit
- Different Types of Quality Audits
- What is Quality Management System?
- How to Know if You Ready for the Audit?
- Learn about GxP/GMP Regulations
- How Regulations Affect Quality Management System and Quality Audit
- Different Types of Quality Audits
- How to Properly Prepare for Quality Audits
- Actions You Need to Take to Ensure You Pass an Audit.
Course Description
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…
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 4 main components:
- Quality Planning
- Quality Assurance
- Quality Control
- 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.
Join us in this webinar as the framework of GxP/GMP regulations, quality management system, and quality audit will be described.
Why you 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…
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,
- Learn what actions you need to take to ensure that your organization will pass an audit.
Areas Covered
- GxP/GMP Framework
- Quality Management System
- Quality Audit
- GxP/GMP Framework
- Quality Management System
- Quality Audit
Who is this course for
- Quality Assurance
- Documentation Management
- Document Control
- Compliance Managers…
- Quality Assurance
- Documentation Management
- Document Control
- Compliance Managers
- QC/QA Managers and Analysts
- Management
- GMP Training Specialists
- Regulatory Affairs Personnel
- Auditors
- Related Subject Matter Experts
Instructor Profile
Galaxy Consulting Founder and President Eleonora Babayants has many years of GxP/GMP hands-on experience in regulated industries. She worked with quality assurance and compliance officers to develop and execute compliance strategies and programs. She participated in the implementation of compliance requirements.
Her many years’ experience includes regulatory compliance, internal and external auditing, change management, documentation and records management, document control, electronic document management systems, information governance, IT systems management and validation.
Eleonora’s past work includes development and implementation of regulatory compliance policies, processes, and procedures, leading implementation and administration of document control and document management systems in full compliance with regulatory requirements, designing and implementing electronic documents workflows, leading enterprise content management initiatives, enabling enterprise search, improving systems information architecture, creating and implementing users’ training programs.
Eleonora ensured document management systems compliance with regulatory requirements. She collaborated with users to develop positive and productive approaches to regulatory compliance, coordinated, prepared, and participated in internal and external audits including FDA audits.
Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.
