Data Security and GxP/GMP Requirements for Information Technology

Why Should You Attend:

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 products must meet certain requirements.

Data security is a high priority in any organization but especially in a regulated industry. Companies need to safeguard against every possible vulnerability across their entire infrastructure. In order to successfully safeguard data, data governance needs to be implemented.

In the regulated environment which must be GxP/GMP compliant, data integrity is extremely important. Companies need to prevent data breaches from happening.

Data is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Data provides the route for auditors to assess the overall quality of operations within a company and the final product.

In order to maintain data in GxP/GMP compliant manner, data security procedures should be developed and implemented.

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

In this webinar, learn how to secure, manage and govern data as well as IT systems in compliance with GxP/GMP requirements and be able to pass a quality audit. Learn how to ensure that IT systems are in compliance with GxP/GMP requirements and how to prepare for e-discovery and crisis.

Areas Covered in the Webinar:

• GxP/GMP Requirements for Information Technology
• IT Systems Validation
• Information Governance
• Data Security
• E-Discovery
• Crisis Preparedness

Who Will Benefit:

• Quality Assurance, Compliance, IT, Medical Affairs, Documentation Management/Document Control

From Pharmaceutical, Medical Devices, Food and Beverages, Cosmetics companies.

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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