Tailored In-House Training

International Auditor Certification Program

Updated Tuesday, April 14, 2026 at 6:04 PM

An intensive 8-day certification program that transforms experienced quality professionals into effective, all-round international pharmaceutical auditors.

Custom On-Site Training

This training is delivered at your location and tailored to your organization's specific needs, processes, and compliance requirements.

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What's included

Program tailored to your organization
Delivered at your location
Flexible scheduling
Training certificate for participants
Experienced trainers from industry and regulatory

Difficulty

Professional level

What you will learn

Develop and execute a risk-based audit strategy tailored to the specific site, product portfolio, and regulatory context

Apply effective audit techniques including rapid auditing, in-depth investigation methods, and structured questioning practices

Communicate audit observations professionally and effectively to auditees at all organizational levels, including in difficult or confrontational situations

Navigate intercultural sensitivities when auditing across different countries and cultural contexts

Analyze and categorize audit findings with a proper root cause diagnosis, distinguishing between systemic and isolated issues

Evaluate data integrity practices, OOS investigations, complaint handling procedures, and CAPA effectiveness during audits

Assess technical systems including HVAC, water systems (WFI, clean steam), computerized systems (GAMP 5, EU Annex 11, 21 CFR Part 11), and aseptic production environments

Write clear, objective, and well-structured audit reports that translate investigational findings into actionable observations

Description

The International Auditor Certification Program is a comprehensive, hands-on training designed to qualify your organization's international (external) auditors. Over the course of eight intensive days, participants develop both the soft skills and technical expertise required to conduct effective, risk-based pharmaceutical audits across the globe.

The program is structured in two complementary parts. The first five days focus on auditing methodology, strategy development, communication skills, intercultural sensitivities, and investigational techniques. These days feature extensive mock audits based on realistic pharmaceutical case studies, allowing participants to practice audit planning, execution, observation analysis, and reporting in a safe environment. Daily exams reinforce learning and track progress.

The final three days deliver specialized technical training covering Good Automated Manufacturing Practices (GAMP 5), computerized system validation, aseptic production, cleanroom concepts, and pharmaceutical utilities (HVAC, water systems, process gases). This technical foundation enables auditors to evaluate complex manufacturing environments with confidence.

Throughout the program, participants work with real-world scenarios including OOS investigations, data integrity assessments, complaint handling, and CMO audit simulations. The progressive mock audit series culminates in a comprehensive examination where participants must demonstrate their ability to plan, execute, and report on a full audit independently.

An optional ninth day is available for participants who will serve as internal trainers, covering adult learning principles, effective teaching strategies, and training program development.

Target Audience

This program is designed for quality professionals who are (or will be) responsible for conducting international external audits on behalf of their organization. Typical participants include Corporate Quality Auditors (CQA), QA managers, compliance officers, and experienced internal auditors who are transitioning to an international external auditing role.

The curriculum covers the full spectrum of pharmaceutical auditing competencies, from foundational audit techniques and risk-based approaches to advanced investigational methods and specialized technical domains. The program integrates theoretical knowledge with extensive practical exercises, including seven progressive mock audit sessions and daily examinations.

Program

Lecture	Day
Introduction to the Training and Auditor Certification Program Welcome, introduction to the trainers, program overview, and the auditor certification framework.	1
Introduction of the Auditors Participants introduce themselves: background, experience, and expectations for the program.	1
Introduction to Auditing: Art or Science Auditing is never an exact science — things can be missed, bias is a risk. Auditing cannot simply be taught; it builds on experience and insight.	1
Audit Techniques Effective techniques such as rapid auditing, focused observation, listening, hearing, waiting. How to ask questions, when to dig deeper, and when to move on.	1
Risk-Based Auditing Understanding the rationale behind risk-based auditing and how to manage risks during an audit. Prioritizing time on high-risk areas rather than spreading effort evenly.	1
Rapid Auditing Auditing with limited time available. Techniques for maximum coverage under time pressure, with emphasis that this is not a preferred method but a necessary skill.	1
Developing a Strategy for an Audit Leveraging organizational policies, SOPs, and standards to build efficient audit plans. Developing independent, tailored strategies for each audit.	1
Mock Audit I: Developing an Audit Strategy and Plan First hands-on exercise using a realistic case study. Participants develop an audit strategy and plan, followed by group evaluation and review of findings.	1
Day 1 Evaluation and Exam Evaluation of the day's learning, followed by a written exam.	1

Lecture	Day
Non-Technical Aspects of Auditing The EDICT model, the psychology of inspection, and good questioning practices. Best practices for effective interviewing.	2
Recording Audit Observations During the Facility Tour How to record observations on the fly in a short and concise manner. Ensuring notes are traceable and usable during the wrap-up.	2
Analyzing Audit Findings: Making the Correct Diagnosis Moving beyond surface-level observations to root cause analysis. Diagnosing what is actually wrong rather than simply documenting symptoms.	2
Communicating Audit Observations to the Auditee Maintaining professionalism and tact while communicating observations during the facility tour. Persisting with questions when answers are unsatisfactory.	2
Auditing Terminology and Sensitivities Common audit terminology in English for non-native speakers. Adapting communication style to the situation.	2
Mock Audit II: Communicating Audit Observations Participants are presented with observations and scenarios requiring different communication approaches, followed by group presentation and prioritization discussion.	2
Day 2 Evaluation and Exam Evaluation of the day's learning, followed by a written exam.	2

Lecture	Day
Auditing Around the Globe: Intercultural Sensitivities Overview of what is acceptable and what is not across different cultures. Preparing auditors for international assignments with cultural awareness.	3
Real-Life Case Study Introduction, analysis, and group presentation of a real-life pharmaceutical incident case study, applying investigational skills.	3
The Pharmaceutical QMS: Identifying Weak Spots A holistic view of the Quality Management System — identifying potential pitfalls and understanding that a QMS may look adequate on paper but fail in practice.	3
How to Conduct In-Depth Investigations Where to dig when something seems wrong, how to prioritize investigations with limited time, and how to conduct investigations with maximum results.	3
Mock Audit III: Investigating In-Depth In-depth investigation exercise using a pharmaceutical case study, followed by group discussion of results.	3
Day 3 Evaluation and Exam Evaluation of the day's learning, followed by a written exam.	3

Lecture	Day
Regulatory Expectations Worldwide Regulatory frameworks and inspection approaches from FDA, PIC/s, EMA, and regional authorities in South America, Asia, and Africa.	4
Data Integrity Where to look for data integrity issues, how to dig deeper when issues are found, categorizing findings, and what they reveal about the overall state of the QMS.	4
Analytical Laboratories Key aspects of auditing analytical laboratories, including equipment, methods, and documentation.	4
Deviations and OOS Investigations in the Lab How to evaluate laboratory deviation handling and Out of Specification investigation procedures during an audit.	4
Mock Audit IV: Investigating OOS in the Lab Hands-on exercise investigating OOS results using a case study, followed by group presentation of findings.	4
Mock Audit V: Investigating Complaints Exercise focused on complaint investigation — what to look for, how to verify proper complaint handling.	4
Product Recalls and Product Security Investigating recall documentation, timelines, and execution. Key points of attention when auditing product recall and security procedures.	4
Day 4 Evaluation and Exam Evaluation of the day's learning, followed by a written exam.	4

Lecture	Day
Auditing API Manufacturers Specific points of attention when auditing Active Pharmaceutical Ingredient manufacturers.	5
Controls on Packaging Major points of attention in warehouses and during distribution. GDP requirements related to packaging controls and supply chain integrity.	5
Auditor Tools How to utilize Site Master Files, existing organizational knowledge, and inspection reports to prepare for an audit.	5
Providing Feedback in Undesirable Situations How to provide feedback when the auditee is uncooperative or confrontational. Standing your ground while facing opposition.	5
Mock Audit VI: Working with Difficult Auditees Exercise and role-play focused on communicating audit observations and handling difficult auditee behavior.	5
Writing Audit Reports: Tips and Standards Creating a common reporting standard. Tips for shortening the reporting phase, summarizing data and observations.	5
Mock Audit VII: Reporting and Communicating (Examination) Final mock audit as practical examination. Participants independently produce a complete audit report and communicate findings.	5

Lecture	Day
GAMP 5: Overview of the Guideline Introduction to Good Automated Manufacturing Practices and the GAMP 5 framework.	6
System Lifecycle and Specifications Understanding the system lifecycle approach and the role of specifications in computerized system validation.	6
Quality Risk Management for Computerized Systems Applying quality risk management principles to computerized systems in pharmaceutical environments.	6
The GAMP Categories and Risk-Based Verification Understanding software categories and applying risk-based verification strategies.	6
EU Annex 11 and FDA 21 CFR Part 11 Regulatory requirements for computerized systems under EU Annex 11 and FDA 21 CFR Part 11. Key aspects and practical implications.	6
Workshop: Determining System Risk Hands-on workshop assessing system risk for a given scenario, followed by group discussion.	6
User Roles, User Access, and Digital Signatures Evaluating user access controls, role-based permissions, and digital signatures in computerized systems.	6
Audit Trails and Data Integrity Assessing audit trail functionality and data integrity controls in computerized systems.	6
Reviewing Validation Documentation How to evaluate validation documentation packages during an audit of computerized systems.	6
Day 6 Evaluation and Exam Evaluation of the day, wrap-up discussion, and written exam.	6

Lecture	Day
Aseptic Production: An Introduction Fundamentals of aseptic production processes and their significance in pharmaceutical manufacturing.	7
Mapping Out an Aseptic Process How to map and understand the flow of an aseptic production process, including discussion of key challenges.	7
The Revised EU GMP Annex 1 Key requirements and changes introduced by the revised EU GMP Annex 1 on sterile medicinal products.	7
Cleanroom Concepts Cleanroom classification, design principles, and operational requirements for pharmaceutical manufacturing.	7
Cleaning and Disinfection Cleaning and disinfection strategies, agent selection, and validation in aseptic environments.	7
Working in a Cleanroom Personnel behavior, gowning procedures, and operational discipline required for cleanroom work.	7
Media Simulations The role of media fill tests in demonstrating aseptic process capability.	7
Sterilization Overview of sterilization methods, their validation requirements, and key audit points.	7
Release of Sterilized Products Requirements and decision criteria for the release of sterilized pharmaceutical products.	7
Day 7 Evaluation and Exam Evaluation of the day, wrap-up discussion, and written exam.	7

Lecture	Day
Introduction to Utilities and Facilities Overview of pharmaceutical utilities and their critical role in GMP manufacturing environments.	8
Water and Gases (WFI, Clean Steam) Pharmaceutical water systems, Water for Injection, clean steam, and associated quality requirements.	8
The HVAC System: Concept and Design Heating, ventilation, and air conditioning systems — design concepts, qualification, and key audit focus areas.	8
Water Engineering and Qualification Engineering aspects of pharmaceutical water systems, qualification approaches, and ongoing monitoring.	8
Process Gases and Vacuums Pharmaceutical process gases, vacuum systems, and their quality requirements in manufacturing.	8
Overall Examination Comprehensive written exam covering all eight days of the program.	8
Discussion of Results and Lessons Learned Review of examination results, overall program evaluation, and reflection on key lessons learned.	8

Results

After completing this program, participants will be able to independently plan, execute, and report on international pharmaceutical audits. They will be equipped to develop risk-based audit strategies, effectively communicate observations to auditees at all organizational levels, conduct in-depth investigations into complex quality issues including data integrity and OOS results, and evaluate technical systems such as HVAC, water systems, and computerized systems. Participants who pass all examinations receive certification as qualified international auditors.

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Good Distribution Practices (GDP) - including the Responsible Person (blended)

Deviation & CAPA Management

International Auditor Certification Program

Custom On-Site Training

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