Document Control and Change Control Process in GxP/GMP Environment
Instructor:
Eleonora Babayants
Product ID: 705682
Training Level: Intermediate
- Duration: 90 Min
Why Should You Attend:
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. Hence in the GxP/GMP compliant environment , 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. Auditors pay particular attention to documentation to make sure that it complies with GMP and GDP. Similarly Change control within quality management systems (QMS) is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.
Do you know how to properly manage and control your documentation so that your organization can pass GMP audit? Attend this webinar to Learn how to manage and control documents in compliance with GxP/GMP requirements and how to create change control procedure for documentation so that you will be able to pass quality audit.
Areas Covered in the Webinar:
- GxP/GMP and Documentation
- Purpose of Document Control
- Controlled Documents – Types, Identification
- Role of QA in Document Control
- Document Control Procedures
- Document Management System
- Measuring Success of Document Control System
- Change Control Procedure
Who Will Benefit:
- Quality Assurance
- Documentation Managers
- Records Managers
- Document Control
- Compliance
- Medical Affairs
- IT
Eleonora Babayants
Founder and President, Galaxy Consulting
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.
More Training By Experts
- Quality Management and Quality Audit According to GxP/GMP Requirements
- Data Integrity of GxP/GMP Data: e-Discovery and Crisis Preparedness
- Good Documentation Practice (GDocP) for FDA Regulated Industry
- GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems
- Information – Governance, Risk, Compliance
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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).
