Information – Governance, Risk, Compliance

Why Should You Attend:

Documentation is a critical tool for ensuring GxP/GMP compliance in regulated industries. In order to maintain documentation in GxP/GMP compliant manner, information governance should be developed and implemented.

Data security is the high priority 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 the high priority in any organization but especially in a regulated industry.

Learning Objectives:

• 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.
• In order 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.
• It is imperative to secure data, prepare for e-discovery, and be ready if crisis strikes.

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.

Topic Background:

GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics.

Documentation is a critical tool for ensuring GxP/GMP compliance. In order to maintain documentation in GxP/GMP compliant manner, information governance procedures should be developed and implemented.

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