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Home » AI Quality Management for Regulatory & Compliance Professionals

Expert-in-the-Loop™ – AI Regulatory Compliance Management for GxP Validation & Data Integrity

".$CATvalue."Transform your quality, validation, and regulatory career. Master the use of Artificial Intelligence (AI) in regulated environments.

AI-EILPro™ Certification
Next-Gen Compliance: Leading AI in Life Sciences

As AI, machine learning (ML), and large language models (LLMs) reshape life sciences software, skilled human oversight is critical. This certification shifts your approach from traditional, document-driven compliance to a dynamic, risk-based Computer Software Assurance (CSA) model rooted in critical thinking.

Key Highlights

  • Establish Expert Control: Learn to build the essential Expert-in-the-Loop™ layer to keep AI systems compliant, reliable, and defensible.
  • Master CSA Principles: Transition from static validation to agile, risk-based assurance strategies.
  • Design & Oversee AI Processes: Gain practical skills to evaluate AI-driven workflows for regulatory confidence.
  • Ensure Data Integrity: Help ensure AI outputs remain accurate, safe, and fit for use in highly regulated environments.
  • Drive Operational Excellence: Balance powerful technology with strict compliance to protect data integrity and maintain organizational trust.


AI Regulatory Compliance Management Programs:


Certification Training AI Quality Risk Management: GxP Validation & Data Integrity Professional Certification Program
Professional Certification Program:

AI Quality Risk Management: GxP Validation & Data Integrity Professional Certification Program

Course ID: AI-201
Method of Training: Online, asynchronous, self-paced eLearning.
Price: $1495.00


Certification Training Introduction to AI Quality Risk Management & Compliance: The Expert-in-the-Loop (EIL)
Free Introductory Course w/Certificate of Completion:

Introduction to AI Quality Risk Management & Compliance: The Expert-in-the-Loop (EIL)

Course ID: AI-101
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 60 minutes
Free Course: Start Learning, Today!
Price: $0.00


Certification Training Validation of FDA-Regulated Systems Using AI, Machine Learning & Large Language Models
Individual Course w/Certificate of Completion:

Validation of FDA-Regulated Systems Using AI, Machine Learning & Large Language Models

Course ID: AI-201.01
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 90 minutes
Price: $225.00


Certification Training Computer System Validation (CSV) and Computer Software Assurance (CSA): Agile, GAMP5 V-Model and SDLC
Individual Course w/Certificate of Completion:

Computer System Validation (CSV) and Computer Software Assurance (CSA): Agile, GAMP5 V-Model and SDLC

Course ID: AI-201.02
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 90 minutes
Price: $195.00


Certification Training Role of the AI Expert-in-the-Loop: Foundations
Individual Course w/Certificate of Completion:

Role of the AI Expert-in-the-Loop: Foundations

Course ID: AI-201.03
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 90 minutes
Price: $195.00


Certification Training AI Applications: Emerging FDA Trends & CSV Basic Concepts
Individual Course w/Certificate of Completion:

AI Applications: Emerging FDA Trends & CSV Basic Concepts

Course ID: AI-201.04
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 60 minutes
Price: $195.00


Certification Training Quality Risk Management for AI Applications
Individual Course w/Certificate of Completion:

Quality Risk Management for AI Applications

Course ID: AI-201.05
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 60 minutes
Price: $195.00


Certification Training AI Expert-in-the-Loop Core: Applied Skills
Individual Course w/Certificate of Completion:

AI Expert-in-the-Loop Core: Applied Skills

Course ID: AI-201.06
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 60 minutes
Price: $495.00


Certification Training AI Applications and Quality Management in GxP Environments
Individual Course w/Certificate of Completion:

AI Applications and Quality Management in GxP Environments

Course ID: AI-501
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 60 minutesBiopharma Institute
Price: $195.00


Certification Training Validation & Compliance: Commercial-off-the-shelf (COTS), Software-as-a-service (SaaS) and Cloud Systems
Individual Course w/Certificate of Completion:

Validation & Compliance: Commercial-off-the-shelf (COTS), Software-as-a-service (SaaS) and Cloud Systems

Course ID: CSA-301
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 120 minutes
Price: $245.00


Certification Training Validation: Computer System Validation (Part 1 of 2) (Planning)
Individual Course w/Certificate of Completion:

Validation: Computer System Validation (Part 1 of 2) (Planning)

Course ID: VAL09
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 60 minutes
Price: $195.00


Certification Training Validation: Computer System Validation (Part 2 of 2) (Implementation)
Individual Course w/Certificate of Completion:

Validation: Computer System Validation (Part 2 of 2) (Implementation)

Course ID: VAL10
Method of Training: Online, asynchronous, self-paced eLearning.
Average Learning Time: 60 minutes
Price: $195.00


Have Questions? Contact Us:


Use the form below to request more information about our programs. You can also request a quote for group training or an invoice to generate a company purchase order. For quotes or invoices, please include the course title(s) and the number of students.

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For quotes or invoices please provide the titles of the course(s) and number of students.