FDA Design and Document Change Control

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.

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 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.

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.

Learning Objectives:

• Understand regulatory requirements and FDA expectations for document and design 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:

• 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

Denise Arrington
Quality and Regulatory professional, D & M Global Consulting LLC

Denise Arrington is an experienced Quality and Regulatory professional with over 25 years in the medical device manufacturing industry. I have worked with Class I, II and III medical devices where I have developed implemented and managed Quality Systems as required by domestic and international regulations, such as, but not limited to FDA, ISO, European Union, Therapeutic Goods Australia and Health Canada. I am a trained ISO 13485 Lead Auditor/Auditor. I have over 20 years of experience working closely with domestic and international regulatory agencies, competent authorities and notified bodies. I have experience in drafting and maintaining Design History Files and technical files. I also have experience with drafting and submitting 510(k)s, technical dossiers and other regulatory submissions and responses.

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