The "Golden Rules of Being a Successful GMP (Good Manufacturing Practice) Auditor Training Course" training has been added to ResearchAndMarkets.com's offering.

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.

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.

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

Who Should Attend:

This training will suit those in the following departments:

• Quality Assurance
• Quality Control
• GMP Compliance
• Auditing
• IT
• Regulatory Affairs
• Engineering
• Supply Chain

Key Topics Covered:

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

• Hands-on workshop to practice preparing a GMP audit report

Reporting audit findings and communicating results cont.

• Rule 9: learn from every audit
• How to build a culture of continuous improvement in the auditing process
• Self-assessment and reflection: improving your auditing skills over time
• How to measure and monitor the effectiveness and efficiency of GMP Audits
• Staying up-to-date with regulatory changes and GMP updates

For more information about this training visit https://www.researchandmarkets.com/r/asr7gc

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