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Good Documentation Practice (GDocP) for FDA Regulated Industry - Webinar

  • ID: 4899800
  • Webinar
  • August 2019
  • Region: Global
  • 90 Minutes
  • Compliance Online
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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:

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
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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.
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