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Change Control for FDA Regulated Industries

4920
Duration : 90 Minutes

Eleonora Babayants,

Galaxy Consulting Founder and President Eleonora Babayants is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document manag Read more


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.

Course Outline:

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
• What types of changes are subject to change control
• Change control plan/model, procedures, and steps
• Describe, justify, plan, and execute a change
• Conduct a proper change risk assessment
• Avoid risks during the change control process
• Change control procedures for documentation
• Change control procedures for IT systems

What You Get:

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

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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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