Dublin, Nov. 03, 2025 (GLOBE NEWSWIRE) -- The "Golden Rules of Being a Successful GMP (Good Manufacturing Practice) Auditor Training Course (Feb 5th - Feb 6th, 2026)" training has been added to ResearchAndMarkets.com's offering.
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 processLearn how to effectively identify GMP non-conformities, from documentation errors to deviations in manufacturing processesAlign your auditing skills with global GMP standards, helping you stay compliant with industry regulationsUnderstand how to assess audit findings and suggest practical, effective corrective actionsDevelop 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 recordsCertificate of completion
Who Should Attend:
This training will suit those in the following departments:
Quality AssuranceQuality ControlGMP ComplianceAuditingITRegulatory AffairsEngineeringSupply Chain
Key Topics Covered:
Day 1
Introduction to GMP and the role of an auditor
Overview of Good Manufacturing Practices (GMP) and their importanceUnderstanding the role of GMP auditors in ensuring quality and complianceKey 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 independenceRule 2: prepare thoroughly before the auditRule 3: focus on critical areas and risksRule 4: document findings accurately and clearlyUnderstanding the importance of these principles in conducting effective audits
Planning and preparing for GMP audits
How to define audit objectives and scopeCreating effective audit checklists and planning strategiesPre-audit preparations: reviewing documents, data, and previous audit reportsCommunicating expectations with the audit team and auditees
Conducting the audit - techniques and best practices
Rule 5: effective communication with auditeesHow to ask the right questions and observe processesTechniques for assessing facilities, equipment, and quality systemsHow 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-conformitiesTechniques for spotting GMP violations and quality issuesAssessing risks associated with non-conformities and their potential impact on product qualityUnderstanding the severity of findings and classifying risks
Corrective and preventive actions (CAPA)
Rule 7: effective corrective and preventive actionsUnderstanding CAPA and its importance in GMP auditingHow to work with auditees to develop actionable CAPA plansFollow-up processes: verifying that corrective actions are implemented
Reporting audit findings and communicating results
Rule 8: clear and objective reporting of findingsBest practices for writing audit reportsHow to communicate audit findings effectively to management and auditeesHandling 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 auditHow to build a culture of continuous improvement in the auditing processSelf-assessment and reflection: improving your auditing skills over timeHow to measure and monitor the effectiveness and efficiency of GMP AuditsStaying up-to-date with regulatory changes and GMP updates
For more information about this training visit https://www.researchandmarkets.com/r/7lqk9g
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Being a Successful GMP (Good Manufacturing Practice) Auditor Training Course: Techniques to Assess Compliance, Identify Non-Conformities, and Drive Continuous Quality (Feb 5th - Feb 6th, 2026)
Publié il y a 5 jours
Nov 3, 2025 at 3:35 PM
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