Document Control and Change Control Process in GxP/GMP Environment

In this Gxp/GMP 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 will be described as well as change control procedures for documentation.

Why Should You 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. Hence in the GxP/GMP compliant environment , 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. Auditors pay particular attention to documentation to make sure that it complies with GMP and GDP. Similarly 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.

Do you know how to properly manage and control your documentation so that your organization can pass GMP audit? Attend this webinar to Learn how to manage and control documents in compliance with GxP/GMP requirements and how to create change control procedure for documentation so that you will be able to pass quality audit.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

• Quality Assurance
• Documentation Managers
• Records Managers
• Document Control
• Compliance
• Medical Affairs
• IT

Eleonora Babayants
Founder and President, Galaxy Consulting

Eleonora Babayants - Founder and President Galaxy Consulting, 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, medical devices, food and beverages companies.

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