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. Get insights on how to manage and govern documents as well as IT systems in compliance with GxP/GMP requirements to be able to pass quality audit. Learn how to secure your data, prepare for e-discovery and crisis.
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:
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.
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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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