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60 Minutes Live Webinar GxP/GMP and its Consequences for


Date
Sep 28, 2021 - 01:00 PM - Sep 29, 01:00 PM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

Session Highlights
  • GxP/GMP and Documentation
  • 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

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




Who Will Benefit
  • Quality Assurance
  • Documentation Managers
  • Records Managers
  • Document Control
  • Compliance
  • Medical Affairs
  • IT


Speaker Details


key learning objectives
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system.



Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]

Event Categories
Keywords: pharmaceutical




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