How to Manage Internal GMP (Good Manufacturing Practice) Audits In-house Training

Part of Audit Essentials: From Interviews to Inspections series:

Course overview

This intensive two-day training course will equip you with the essential skills and knowledge needed to effectively plan, manage, and execute internal GMP audits. As part of the pharmaceutical industry’s commitment to producing safe and effective products, Good Manufacturing Practices (GMP) audits are crucial for maintaining compliance with regulatory standards and ensuring product quality. Internal GMP audits play a vital role in identifying potential risks, ensuring manufacturing processes adhere to the highest quality standards, and preparing your organisation for external regulatory inspections.

Whether you’re new to auditing or looking to refine your existing processes, this programme will provide you with the tools needed to conduct thorough audits that assess compliance, identify non-conformities, and drive continuous improvement within your organisation.

By the end of this training, you will be able to confidently manage internal GMP audits, ensuring your company consistently meets regulatory requirements and maintains the highest levels of product quality and safety.

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Benefits of attending

• Gain an understanding of the internal audit process, from planning and execution to reporting and follow-up
• Learn how to establish a structured internal audit program that aligns with GMP requirements
• Develop skills to create effective audit plans, define audit scope, and prioritise areas of focus based on risk and criticality, ensuring audits are thorough and efficient
• Strengthen your ability to identify non-conformities, assess risks, and mitigate potential issues before they escalate.
• Understand how to evaluate audit findings and develop actionable corrective and preventive action (CAPA) plans.
• Identify ways to streamline the internal audit process, saving time and resources while maintaining a high level of audit quality

Who should attend

This training will benefit those in the following departments:

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