Good Documentation Practice (GDocP) for FDA Regulated Industries

10:30 AM ET | 07:30 AM PT | 09:30 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"Eleonora Babayants is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management"

Connection between GxP/GMP and document control

Description

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Inadvertent use of out-of-date documents or not approved documents can have significant negative consequences on quality, costs, customer satisfaction, and can even cause death.

Why Should you attend

In the regulated industries which must be GxP/GMP compliant, document control is the cornerstone of the quality 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.

Learn how to manage and control documents in compliance with GxP/GMP requirements and be able to pass quality audit.

Learn how to secure, manage and govern your documentation in compliance with GxP/GMP requirements and be able to pass quality audit

Only controlled documents should be used to perform work. But not all documents need to be controlled.

In this webinar, describe 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.

Learning Objectives

In the regulated environment which must be GxP/GMP compliant, 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.

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.

Auditors pay particular attention to documentation to make sure that it complies with GMP and GDocP. Therefore, in order for an organization to meet GxP/GMP requirements, it must have a document control system in place.

Learn how to manage and control documents in compliance with GxP/GMP requirements and be able to pass quality audit.

Areas Covered

  • 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 

Industries who can attend

This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Eleonora Babayants

Galaxy Consulting Founder and President Eleonora Babayants 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, knowledge base 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, and medical devices companies.

Back to Top