Golden Rules of Being a Successful GMP (Good Manufacturing Practice) Auditor Training Course (ONLINE EVENT: October 1-2, 2025)- Product Image

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Golden Rules of Being a Successful GMP (Good Manufacturing Practice) Auditor Training Course (ONLINE EVENT: October 1-2, 2025)

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Training
2 Days
Oct 1st 09:30 - Oct 2nd 17:00 GMT+1
IPI Academy
ID: 6075764

€245EUR$275USD£200GBP OFF until Aug 27^th 2025

Navigating thorough and successful GMP audits can be a challenging experience within the pharmaceutical industry. GMP auditors play a vital role in safeguarding public health by assessing and ensuring that manufacturing processes meet stringent regulatory standards. Therefore, Good Manufacturing Practices (GMP) are crucial for ensuring product safety, quality, and efficacy.

This training will equip you with the essential tools, strategies, and best practices needed to excel as a GMP auditor. Whether you are new to auditing or an experienced professional, this specially designed programme will guide you through the core principles that lead to successful GMP audits. You will learn how to effectively assess compliance with GMP standards, conduct thorough audits, identify non-conformities, and recommend corrective actions to drive continuous improvement.

Focusing on the "Golden Rules" for a successful GMP auditor, you will learn that these principles go beyond technical knowledge. They emphasise building strong communication, developing keen observational skills, and fostering a collaborative approach with auditees - all of which are essential for ensuring the highest compliance and quality in manufacturing environments.

By the end of this training, you will have a deeper understanding of the GMP audit process and an increased confidence in conducting audits with objectivity and professionalism. Additionally, you will have enhanced your ability to make impactful decisions that ensure compliance, quality, and safety.

Benefits of attending

Gain a comprehensive understanding of the "Golden Rules" of GMP auditing and how they apply to the audit process
Learn how to effectively identify GMP non-conformities, from documentation errors to deviations in manufacturing processes
Align your auditing skills with global GMP standards, helping you stay compliant with industry regulations
Understand how to assess audit findings and suggest practical, effective corrective actions
Develop a risk-based mindset, allowing you to prioritise audit focus areas and address critical compliance issues that could impact product quality and safety

Certifications:

CPD: 12 hours for your records
Certificate of completion

Course Content

Day 1

Introduction to GMP and the role of an auditor

Overview of Good Manufacturing Practices (GMP) and their importance
Understanding the role of GMP auditors in ensuring quality and compliance
Key regulatory authorities (FDA, EMA, MHRA, WHO, PIC/S, TGA) and their GMP requirements

The golden rules of GMP auditing: core principles

Rule 1: maintain objectivity and independence
Rule 2: prepare thoroughly before the audit
Rule 3: focus on critical areas and risks
Rule 4: document findings accurately and clearly
Understanding the importance of these principles in conducting effective audits

Planning and preparing for GMP audits

How to define audit objectives and scope
Creating effective audit checklists and planning strategies
Pre-audit preparations: reviewing documents, data, and previous audit reports
Communicating expectations with the audit team and auditees

Conducting the audit - techniques and best practices

Rule 5: effective communication with auditees
How to ask the right questions and observe processes
Techniques for assessing facilities, equipment, and quality systems
How to maintain professionalism and objectivity during the audit

Workshop - working on the draft audit agenda

Hands-on workshop to practice preparing a GMP audit agenda

Day 2

Identifying GMP non-conformities and risks

Rule 6: be thorough in identifying non-conformities
Techniques for spotting GMP violations and quality issues
Assessing risks associated with non-conformities and their potential impact on product quality
Understanding the severity of findings and classifying risks

Corrective and preventive actions (CAPA)

Rule 7: effective corrective and preventive actions
Understanding CAPA and its importance in GMP auditing
How to work with auditees to develop actionable CAPA plans
Follow-up processes: verifying that corrective actions are implemented

Reporting audit findings and communicating results

Rule 8: clear and objective reporting of findings
Best practices for writing audit reports
How to communicate audit findings effectively to management and auditees
Handling discrepancies, disagreements, and difficult situations during the report phase

Workshop: working on the draft audit report