Data Security: Secure, Manage and Govern Data as well as IT Systems in Compliance with GxP/GMP Requirements

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.

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

In this webinar, we will review GMP requirements for IT systems. We will review data security and data governance procedures and how to implement them. You will also learn how to implement data security, e-discovery and crisis preparedness.

Why Should You Attend:

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.

Course Outline:

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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Senior Quality Managers
• Quality Professionals
• Regulatory Professionals
• Compliance Professionals
• Production Supervisors
• Validation Engineers
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners
• Quality Engineers
• Quality Auditors
• Document Control Specialists
• Documentation Management Personnel
• IT Professionals
• Medical Affairs Personnel
• Records Management Personnel

Contact Us

Galaxy Consulting Founder and President Eleonora Babayants 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, knowledge base 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, and medical devices companies.
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