GMP-Auditor Forum

Presentations

• ECA’s GMP-Auditors Reference Handbook
• Global Inspection and Audit Experience
• Auditing AI Applications
• Auditor Rights and Limits

Interactive Sessions

• Difficult Audit Situations
• Self-Inspections
• Digital Proficiency
• The Use of AI
• Observation Categorisation
• Auditing new Facilities
• Hybrid and Distant Assessments

Objectives

In this format, GMP-Auditors can discuss current topics and exchange opinions and experiences with other auditors in moderated interactive session. The presentations will address specific topics deemed important for GMP-Auditors.

A team of experts has been developing the ECA Good Practice Guide “GMP Auditors Reference Handbook”. The guide considers feedback from GMP inspectors, the pharmaceutical industry and suppliers as well as practical experiences from real project cases. Experts working on this guide will be present so participants will have the opportunity to discuss current challenges around GMP Auditing.

All members of the Association will have the possibility to download the current version of the guide free of charge.

Background

Manufacturers are obliged to carry out GMP audits at their suppliers’ and contract manufacturers’ premises or have them carried out by suitably qualified and trained external auditors. Auditors play a very important role in the pharmaceutical industry and in the life cycle of pharmaceutical products. Their training and experience, and thus also a mutual exchange, is immensely important here.

What makes a good auditor?

An auditor must certainly have extensive specialist knowledge of the GMP regulations and their implementation. But an auditor must also have the necessary technical and practical expertise to sufficiently understand and question the audited processes. To do this, an auditor must be unbiased and independent, know appropriate questioning techniques and be able to apply them. It also requires patience, the ability to listen, persistence and determination. Unfamiliar and new situations must not become a problem.

The ECA Certified GMP-Auditor certification programme consists of three modules that provide GMP auditors with specialised knowledge and soft skills, including conflict resolution. And auditors gain experience in their daily professional practice. This additional GMP-Auditor Forum format aims to present and
discuss current topics and promote mutual exchange of opinions and experiences.

Target Audience

This Forum is designed for both new and experienced GMPAuditors who want to network and broaden their overall knowledge.

Moderator

Wolfgang Schmitt
(On behalf of ECA)