Change Control for FDA Regulated Industries

Live Webinar | Danielle DeLucy | From: Aug 31, 2020 - To: Dec 31, 2020

Training Options & Pricing

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Recorded Session     $229
DVD     $249
Recorded Session & DVD     $389
Transcript (Pdf)     $229
Recorded & Transcript (Pdf)     $379
DVD & Transcript (Pdf)     $389


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 the 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 the software.

Area Covered in this session:-

  • Total product life cycle approach to AI/ ML design
  • Application of FDA software Pre Cert program to AI/ ML
  • FDA discussion paper on AI/ML
  • Database management
  • QC of datasets
  • Algorithm updating
  • Reference standard development
  • Standalone performance testing
  • Clinical performance testing
  • Data enrichment
  • Emphasis on “explainability”
  • Additional labeling requirements
  • Cybersecurity

Why Should You Attend:-

One of the top FDA warning citations is for inadequate change control. During FDA inspections, change control gets a 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 the release of the sub-standard product or product recall. A pattern of deficiently implemented changes may require costly and time-consuming remediation efforts.

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

Who Will Benefit:-

  • Software Engineers
  • Engineers
  • Regulatory personnel
  • Quality Assurance personnel
  • Marketing
  • Management