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About the Course

Profile & Expectations

Course Learning Objectives

Lesson 1.1: Introduction - Defining the Role of Auditors in Challenging GxP Environments

Lesson 1.2: Maintaining Objectivity and Addressing Bias

Lesson 1.3: Introduction to Advanced Frameworks, Techniques, Tools, and Methods for Value-Added, Objective Audits

Lesson 1.4: Ethics, Privacy, and Transparency in Auditing

Foundational Test

Lesson 2.1: Using the GxP+ Library

Lesson 2.2: Scenarios to learn how to identify the appropriate requirements with the GxP+ Library

Lesson 3.1: Assessing the Audit Setting

Lesson 3.2: Managing the Audit - Request and Evidence

Lesson 3.3: Handling Difficult Conversations and Challenging Auditees

Lesson 3.4: Investigative Interviewing for Fraud and Misconduct Detection

Lesson 3.5: Conflict Resolution, Negotiation, and Cultural Differences

Lesson 4.1: Strategies for Auditing in Non-Cooperative Environments

Lesson 4.2: Identifying Red Flags and Root Causes in GxP Audits

Lesson 4.3: Techniques and Tools - Fraud or Misconduct

Lesson 4.4: Data Analysis Techniques for Root Cause and Trend Identification

Lesson 4.5: Applying AI for Predictive Auditing and Anomaly Detection

Lesson 4.6: Advanced Risk Assessment Based on Historical Data and Real-Time Data

Lesson 4.7: Maximizing Audit Impact When Time is Limited

Lesson 4.8: Maximazing Resources - Auditing Cross-Project Trends and Organizational Risks

Tips and Tricks

Chapter 4 Test

Lesson 5.1: Introduction to AI in Auditing

Lesson 5.2: Ensuring Safe and Ethical Use of AI in Auditing

Lesson 5.3: Effective Prompting Techniques for AI-Driven Audits & Assignment

Lesson 5.4: AI Auditing - Use Cases and Tools

Lesson 5.5: Building and Maintaining an AI-Enhanced Audit Strategy