3-Hour Virtual Seminar on GxP/GMP and its Consequences Recorded Webinar | Eleonora Babayants | From: Aug 31, 2021 - To: Dec 31, 2021 |
3-Hour Virtual Seminar on GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems (IT systems)
GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. GMP regulations describe the required quality management system for the 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.
A quality management system ensures that a product is safe and meets its intended use. A 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 a quality management system which is carried out by an internal or external auditor or an audit team. It is an important part of an 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.
Documentation is a critical tool for ensuring GxP/GMP compliance.
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.
There are also GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of the regulated product must meet certain requirements.
Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure.
In this webinar, the connection between GxP/GMP and document control will be discussed. Details of document control procedures and the role of Quality Assurance in the documentation systems are described. GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements will be reviewed. There is also a review of the change control procedure and how it should be used in the GxP/GMP environment.
Information governance and data security are high priorities in any organization but especially in a regulated industry.
E-Discovery preparedness makes it imperative for organizations to develop an enterprise-wide strategy to manage the volume of electronic information. The discovery process affects many individuals in an organization, not just lawyers and others involved in discovery, but also IT professionals and records managers who have to be prepared to produce electronic content for discovery and litigation. Crisis preparedness is a high priority in any organization but especially in a regulated industry.
In this webinar, you will learn the framework of GxP/GMP regulations, information governance procedures, and how to implement them. You will also learn how to implement data security, e-discovery, and crisis preparedness.
Areas Covered in the Session:-
Why you should Attend:-
GxP/GMP is about Quality Management systems (QMS) where an organization needs to demonstrate its ability to consistently provide a product that meets customer and applicable statutory and regulatory requirements.
There are few types of quality audits. One of them is the 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 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 the 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.
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.
Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product.
Auditors pay particular attention to documentation to make sure that it complies with GMP and GDP. Therefore, for an organization to meet GxP/GMP requirements, it must have a document control system in place.
Learn how to manage and control documents in compliance with GxP/GMP requirements and be able to pass the quality audit. Learn how to manage IT systems in compliance with GxP/GMP requirements.
To maintain documentation in GxP/GMP compliant manner, information governance procedures should be developed and implemented.
In the regulated industries, manufactures are required to use a change control procedure. Learn about change control procedures for documentation and IT systems.
It is imperative to secure data, prepare for e-discovery, and be ready if a crisis strikes.
Learn how to manage and govern documents as well as IT systems in compliance with GxP/GMP requirements and be able to pass the quality audit.
Learn how to secure your data, prepare for e-discovery and crisis.
Who Will Benefit:-
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.
