GxP/GMP and its Consequences for Documentation and IT System | GMP Training



Documentation is a critical tool for ensuring GxP/GMP compliance and GMP Training

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.


There are also 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.


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 are described. GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements will be reviewed. There is also a review of change control procedure and how it should be used in GxP/GMP environment.


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.


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


In order to maintain documentation in GxP/GMP compliant manner, information governance procedures should be developed and implemented.


In the regulated industries, manufactures are required to use a change control procedure. Learn about change control procedure for documentation and IT systems.


Webinar Takeaway


GxP/GMP Documentation and GMP Training

Purpose of Document Control

Controlled Documents – Types, Identification

Role of QA in Document Control

Document Control Procedures

GxP/GMP Requirements for IT systems in regulated industries

key 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 GDP. 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. Lean how to manage IT systems in compliance with GxP/GMP requirements.


Can't Make this LIVE Webinar?


Simply select the Recorded option when registering and we will send you the link to view the recorded version.


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 and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Visit us  for more information - https://worldcomplianceseminars.com/


 

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