4-Hours Virtual Seminar on GxP/GMP and Its Consequences for QA, Change Management, Documentation and IT Systems
Manage and Control Documents in Compliance with GxP/GMP Requirements and Pass Any Quality Audit.
Instructor :
Eleonora Babayants
Webinar ID:
2333
Date: FEB 27, 2025 (THU)
Start Time: 9:00 AM - 1:00 PM PT
Duration: 4 Hrs.
What you will learn
- How to properly manage and control your documentation to pass GMP audit
- How to manage and control documents in compliance with GxP/GMP requirements
- GMP requirements for IT systems, change control process
- Validation requirements for IT systems
- How to properly manage and control your documentation to pass GMP audit
- How to manage and control documents in compliance with GxP/GMP requirements
- GMP requirements for IT systems, change control process
- Validation requirements for IT systems
- Connection between GxP/GMP and document control
- Document control procedures and the role of Quality Assurance in the documentation systems
- Review change control procedures within quality management systems (QMS) for information technology systems
Course Description
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. Document Control is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.
Documentation is a critical tool for ensuring GxP/GMP compliance.
- Documentation 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.
Change control within quality management systems (QMS) 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.
The goals of a change control procedure include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing a change.
GMP guidelines require that IT systems must be validated by adequate and documented testing. Validation is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results.
There are 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 regulated product must meet certain requirements.
In this webinar, Eleonora Babayants, a regulatory compliance coach will talk about:
- The connection between GxP/GMP and document control
- Details of document control procedures and the role of Quality Assurance in the documentation systems will be described as well as change control procedures for documentation.
- We will review GMP requirements for IT systems.
- We will review change control procedures within quality management systems (QMS) for information technology systems.
- We will describe validation requirements for IT systems.
Join us to now!
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. Document Control is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.
Documentation is a critical tool for ensuring GxP/GMP compliance.
- Documentation 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.
Change control within quality management systems (QMS) 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.
The goals of a change control procedure include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing a change.
GMP guidelines require that IT systems must be validated by adequate and documented testing. Validation is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results.
There are 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 regulated product must meet certain requirements.
In this webinar, Eleonora Babayants, a regulatory compliance coach will talk about:
- The connection between GxP/GMP and document control
- Details of document control procedures and the role of Quality Assurance in the documentation systems will be described as well as change control procedures for documentation.
- We will review GMP requirements for IT systems.
- We will review change control procedures within quality management systems (QMS) for information technology systems.
- We will describe validation requirements for IT systems.
Join us to now!
Why you should attend
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, in order for an organization to meet GxP/GMP requirements, it must have a document control system in place.
Do you know how to properly manage and control your documentation so that your organization can pass GMP audit?
Join Eleonora Babayants, a regulatory compliance coach, to learn how to manage and control documents in compliance with GxP/GMP requirements and be able to pass quality audit.
IT systems must meet GxP/GMP requirements. It is important to notice these requirements since a document management system is required to control documents, so this document management system must meet these requirements for information technology.
According to GxP/GMP regulations, manufactures are required to use a change control procedure.
Change control procedures reduce the possibility that unnecessary changes will be introduced to a system without analysis, introducing faults into the system or undoing changes made by other users of software.
- Learn GMP requirements for IT systems, change control process as it applies to information technology systems in regulated industries, and validation procedure for IT systems.
Enroll Now!
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, in order for an organization to meet GxP/GMP requirements, it must have a document control system in place.
Do you know how to properly manage and control your documentation so that your organization can pass GMP audit?
Join Eleonora Babayants, a regulatory compliance coach, to learn how to manage and control documents in compliance with GxP/GMP requirements and be able to pass quality audit.
IT systems must meet GxP/GMP requirements. It is important to notice these requirements since a document management system is required to control documents, so this document management system must meet these requirements for information technology.
According to GxP/GMP regulations, manufactures are required to use a change control procedure.
Change control procedures reduce the possibility that unnecessary changes will be introduced to a system without analysis, introducing faults into the system or undoing changes made by other users of software.
- Learn GMP requirements for IT systems, change control process as it applies to information technology systems in regulated industries, and validation procedure for IT systems.
Enroll Now!
Areas Covered
- GxP/GMP and Documentation
- Purpose of Document Control
- Controlled Documents – Types, Identification
- Role of QA in Document Control
- Document Control Procedures
- Document Management System
- Measuring Success of Document Control System
- Change Control Procedure
- GxP/GMP Requirements for Information Technology
- Change Control for Information Technology
- IT Systems Validation
- GxP/GMP and Documentation
- Purpose of Document Control
- Controlled Documents – Types, Identification
- Role of QA in Document Control
- Document Control Procedures
- Document Management System
- Measuring Success of Document Control System
- Change Control Procedure
- GxP/GMP Requirements for Information Technology
- Change Control for Information Technology
- IT Systems Validation
Who is this course for
- Quality Assurance
- Documentation Management
- Document Control
- Compliance Managers
- QC/QA Managers and Analysts
- IT, Medical Affairs
- Management…
- Quality Assurance
- Documentation Management
- Document Control
- Compliance Managers
- QC/QA Managers and Analysts
- IT, Medical Affairs
- 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.
