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 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. In this webinar, you will learn the framework of GxP/GMP regulations, information 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, 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. 

Learn how to manage and govern documents as well as IT systems in compliance with GxP/GMP requirements and be able to pass quality audit. 

Learn how to secure your data, prepare for e-discovery and crisis. 

Areas Covered in the Session:

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

• Quality Assurance
• Compliance
• IT
• Medical Affairs
• Documentation Management/Document Control
  
  Speaker Profile 
  
  Eleonora Babayants is a Galaxy Consulting Founder and President, She 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.