Change Control for FDA Regulated Industries

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