Why Should You Attend:
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:
Who Will Benefit:
Galaxy Consulting Founder and President Eleonora Babayants has many years of GxP/GMP hands-on experience in regulated industries. She worked with quality assurance and compliance officers to develop and execute compliance strategies and programs. She participated in the implementation of compliance requirements.
Her many years’ experience includes regulatory compliance, internal and external auditing, change management, documentation and records management, document control, electronic document management systems, information governance, IT systems management and validation.
Eleonora’s past work includes development and implementation of regulatory compliance policies, processes, and procedures, leading implementation and administration of document control and document management systems in full compliance with regulatory requirements, designing and implementing electronic documents workflows, leading enterprise content management initiatives, enabling enterprise search, improving systems information architecture, creating and implementing users’ training programs.
Eleonora ensured document management systems compliance with regulatory requirements. She collaborated with users to develop positive and productive approaches to regulatory compliance, coordinated, prepared, and participated in internal and external audits including FDA audits.
Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.
Good Documentation Practice (GDocP) are the standards in the regulated industries by which documents are created and maintained. Because GDocP is aligned with GxP/GMP, documentation is a critical tool for ensuring GxP/GMP compliance.Inadvertent use of out-of-date documents or not approved documents can have significant negative consequences on quality, costs, customer satisfaction, and can even cause death. Only controlled documents should be used to perform work. But not all documents need to be controlled.
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the Quality Management System. Auditors pay particular attention to documentation to make sure that it complies with GMP and GDP. Documentation is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down. Therefore, in order for an organization to meet GxP/GMP requirements, it must have a document control system in place.
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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. ComplianceOnline 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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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