How to Deal with Difficult Situations in GMP (Good Manufacturing Practice) Audits In-house Training

Part of Audit Essentials: From Interviews to Inspections series:

Course overview

Planning GMP audits with a disciplined and meticulous approach offers numerous benefits for both the GMP auditor conducting the audit and the audited party. While GMP audits are an authority obligation, they also provide added value during internal audits. Additionally, external audits give the audited party the opportunity to discover facts they may not have been aware of.

A GMP auditor must be prepared to handle unexpected situations at any stage of the audit and must complete the qualification process by undergoing the necessary training in this field. While GMP auditors do not evaluate audits solely based on findings, the prejudices, unrest, lack of cooperation, and contrary behavioural patterns of the audited party may lead the auditor to evaluate the audit from a different perspective.

In difficult situations, the auditor should remain polite but firm, maintaining self-control and full command of the audit. This training aims to provide insight from the GMP auditor's perspective, help the audited party cope with challenging situations, and offer strategies for overcoming them.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

Benefits of attending

• Learn effective communication strategies to maintain a positive relationship with auditors, even during tense or difficult moments
• Gain tools for resolving conflicts in a calm and professional manner, helping to avoid misunderstandings or escalations during GMP audits
• Learn how to identify potential compliance risks and address them proactively during an audit, minimising the chance of significant issues
• Improve your ability to build trust and rapport with auditors, leading to better working relationships and smoother audit outcomes
• Discuss the legal and regulatory frameworks surrounding GMP audits, so you’re better prepared to respond effectively and stay compliant
• Consider strategies for turning challenging situations into opportunities for improvement, leading to positive audit results and a more robust quality system

Who should attend

This training would suit those in the following professional roles:

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