Document Control and Change Control Process in GxP/GMP Environment

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

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.

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