About the Course
Profile & Expectations
Course Learning Objectives
Navigating this course
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
