Webinar Duration: 90 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Eleonora Babayants
OVERVIEW:
GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. According to these regulations, change control procedures have to be used. Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.
In the regulated industries, manufactures are required to use a change control procedure. The goals of a change control procedure include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing a change.
In this webinar, change control procedures within quality management systems (QMS) for documentation and information technology systems will be discussed.
Why should you Attend: GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. According to these regulations, manufactures are required to use change control procedures.
Change control procedures reduce the possibility that unnecessary changes will be introduced to a system without analysis, introducing faults into the system or undoing changes made by other users of software.
Learn about change control process and change control procedures as they apply to documentation and information technology systems in regulated industries.
Areas Covered in the Session:
– Change Control Procedures
– Change Control Procedures for Documentation
– Change Control Procedures for IT Systems
Who Will Benefit:
– Quality Assurance
– Documentation Management
– Document Control
– Compliance
– IT
– Medical Affairs
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.
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, and medical devices companies.
