GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. According to these regulations, change control procedures have to be used. Change control within Quality Management System (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. 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.

Why Should You Attend

One of the top FDA warning citations is for inadequate change control. During FDA inspections, change control gets detailed audit. In addition, during the audit, FDA checks change control documents to determine that changes were implemented properly and they do not negatively impact products, equipment, facilities, etc.

Any deficiently implemented change may lead to significant negative events, including release of sub-standard product or product recall. A pattern of deficiently implemented changes may require costly and time-consuming remediation efforts.

Learn about change control process and procedures in regulated industries. This webinar will guide attendees to understand and successfully apply change control steps and best practices.

Learning Objectives

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.

In this webinar, change control procedures within quality management systems (QMS) and Information Technology systems will be discussed.

Attendees will

  • Understand regulatory requirements and FDA expectations for change control
  • Understand what is change control and what is its purpose
  • Learn what types of changes are subject to change control
  • Learn change control plan/model, procedures, and steps
  • Learn to describe, justify, plan, and execute a change
  • Learn how to conduct a proper change risk assessment
  • Learn how to avoid risks during the change control process
  • Learn change control procedures for documentation
  • Learn change control procedures for IT systems

Areas Covered in the Webinar

  • GxP/GMP requirements for change control
  • FDA change control expectations
  • Change control definition and purpose
  • Changes subject to change control
  • Change Control Plan, Procedures, and Steps
  • Change Control Procedures for Documentation
  • Change Control Procedures for IT Systems

Who Will Benefit

  • Quality Assurance
  • Documentation Managers
  • Records Managers
  • Document Control
  • Compliance
  • Medical Affairs
  • IT Professionals
  • Data Managers
  • Safety Managers
  • Systems Administrators
  • Databases Administrators
  • Regulatory Affairs
  • Laboratory managers and supervisors
  • Production managers and supervisors
  • Auditors
  • From Regulated industries such as Pharmaceutical, Medical Devices, Food, Cosmetics, any other regulated industry and not regulated industries; any industry.