This good documentation practice webinar will discuss connection between CxP/GMP and document control, which documents need to be controlled and which are not, what documentation required for QMS, how QA can plays an important role in documentation systems. It will also discuss how change control procedure should be used in GxP/GMP environment.
Good Documentation Practice is the systematic procedure of preparation, reviewing, approving, issuing, recording, storing, and archiving documents.
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 this webinar, we will discuss the connection between GxP/GMP and document control. We will identify controlled documents. We will also describe documents of Quality Management System.
Details of document control procedures and the role of Quality Assurance in the documentation systems will be described. We will also review document management systems, as well as the change control procedure and how it should be used in GxP/GMP environment.Areas Covered in the Webinar:
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.
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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