GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems

In this webinar, we will review GMP requirements for IT systems. We will review change control procedures within quality management systems (QMS) for information technology systems. We will describe validation requirements for IT systems.

Eleonora Babayants
Instructor:
Eleonora Babayants
Date:
Monday, August 17, 2020
Time:
07:30 AM PDT | 10:30 AM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 503254

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Overview:

Documentation is a critical tool for ensuring GxP/GMP compliance.

Documentation 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 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.

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. In the regulated industries, manufactures are required to use a change control procedure.

In this webinar, the connection between GxP/GMP and document control will be discussed. Details of document control procedures and the role of Quality Assurance in the documentation systems will be described as well as change control procedures for documentation.

There are GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.

Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure.

The goals of a change control procedure include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing a change. GMP guidelines require that IT systems must be validated by adequate and documented testing. Validation is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results.

In this webinar, we will review GMP requirements for IT systems. We will review change control procedures within quality management systems (QMS) for information technology systems. We will describe validation requirements for IT systems.

Why you should Attend: 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 GDP. Therefore, in order for an organization to meet GxP/GMP requirements, it must have a document control system in place.

Do you know how to properly manage and control your documentation so that your organization can pass GMP audit?

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

IT systems must meet GxP/GMP requirements. It is important to notice these requirements since a document management system is required to control documents, so this document management system must meet these requirements for information technology.

According to GxP/GMP regulations, manufactures are required to use a change control procedure. The goals of a change control procedure include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change.

Change control procedures reduce the possibility that unnecessary changes will be introduced to a system without analysis, introducing faults into the system or undoing changes made by other users of software. GMP guidelines require that IT systems must be validated by adequate and documented testing.

Learn GMP requirements for IT systems, change control process as it applies to information technology systems in regulated industries, and validation procedure for IT systems.

Areas Covered in the Session:

  • 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
  • GxP/GMP Requirements for Information Technology
  • Change Control for Information Technology
  • IT Systems Validation

Who Will Benefit:
  • Quality Assurance
  • Documentation Management
  • Document Control <
  • Compliance
  • IT
  • Medical Affairs


Speaker Profile
Eleonora Babayants is a Galaxy Consulting Founder and President, She 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, and medical devices companies.


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