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.

Course Objectives:

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? Are your IT systems GxP/GMP compliant?

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. Learn about different types of quality audits and how to properly prepare for them, what actions you need to take to ensure that your organization will pass an audit.

Why Should You Attend:

GxP/GMP is about Quality Management System (QMS) where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements.

There are few types of quality audits. One of them is GMP audit. GMP audit is very important and critical for an organization in a regulated industry. The preparations for the audit should be done properly before the audit. The primary objective of the audit is to demonstrate the compliance with GxP/GMP regulations.

Course Outline:

• 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 and IT Systems
• IT Systems Validation Document Control System
•  Change Control Procedure

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

•  Quality Assurance
•  Documentation Managers
•  Records Managers
•  Document Control
•  Compliance Professionals
•  Medical Affairs Professionals
• Auditors
• Quality Professionals
• Validation Professionals
•  IT Professionals