Change Control for FDA Regulated Industries

Instructor: Eleonora Babayants
Product ID: 706432
Training Level: Intermediate to Advanced
  • 14
  • August 2020
  • 07:30 AM PDT | 10:30 AM EDT
    Duration: 90 Min
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.

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August 14, Friday 07:30 AM PDT | 10:30 AM EDT | Duration: 90 Min

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Read Frequently Asked Questions

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

Free Materials:

  • Presentation
Instructor Profile:
Eleonora Babayants

Eleonora Babayants
Founder and President, Galaxy Consulting

Galaxy Consulting Founder and President Eleonora Babayants has many years of GxP/GMP hands-on experience in regulated industries. She worked with quality assurance and compliance officers to develop and execute compliance strategies and programs. She participated in the implementation of compliance requirements.

Her many years’ experience includes regulatory compliance, internal and external auditing, change management, documentation and records management, document control, electronic document management systems, information governance, IT systems management and validation.

Eleonora’s past work includes development and implementation of regulatory compliance policies, processes, and procedures, leading implementation and administration of document control and document management systems in full compliance with regulatory requirements, designing and implementing electronic documents workflows, leading enterprise content management initiatives, enabling enterprise search, improving systems information architecture, creating and implementing users’ training programs.

Eleonora ensured document management systems compliance with regulatory requirements. She collaborated with users to develop positive and productive approaches to regulatory compliance, coordinated, prepared, and participated in internal and external audits including FDA audits.

Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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