GMP-Auditor Forum

25/26 June 2024, Barcelona, Spain

Course No. 20902

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Speakers

David Abraham

David Abraham

QRS-Associates

Dr Afshin Hosseiny

Dr Afshin Hosseiny

ECA

Jyotsna Agnihotry

Jyotsna Agnihotry

Flavine

Dr Felix Kern

Dr Felix Kern

Merck Healthcare

Thomas Højsholm Schmidt

Thomas Højsholm Schmidt

CSL Behring

Katja Manthey

Katja Manthey

Life Molecular Imaging

Ian Holloway

Ian Holloway

former GMP/GCP/GDP Inspector at MHRA

Dr Agnes Kis

Dr Agnes Kis

Compliance Consultant, formerly F. Hoffmann La-Roche

Dr Maryam Davoudi Keleshteri

Dr Maryam Davoudi Keleshteri

CinnaGen

Dr. Ingrid Walther

Dr. Ingrid Walther

Pharma Consulting Walther

A new ECA Forum to foster Discussions and mutual Exchange in small Working Groups

Objectives

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

A team of experts have developed a new ECA Good Practice Guide “ECA Code of Practice for GMP Auditors”. 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 delegates will receive a free copy and the possibility to download the current 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. Authorities emphasise the need for on-site audits. However, hybrid versions and complete distant assessments also play an important role in the supplier qualification toolbox.

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. This means 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 new GMP Auditor Forum format aims to present and discuss current topics and promote mutual exchange of opinions and experiences.

Target Group

This course is designed for both new and experienced GMP auditors who want to network and broaden their overall knowledge.

ECA´s new GMP-Auditor Guide

In the course of establishing the new ECA Working Group and moving towards becoming an Association, it became apparent that ECA wanted to produce a guide for its members.

We decided early on that we would focus on the most important chapters first, rather than waiting until a full guide was produced. This way we could shorten the time to delivery and also have the opportunity to collect feedback and improve content. The first versions of the chapters have different formats and styles as different volunteer teams were involved in their creation. In the future, we will work on further standardisation and add additional chapters. We would appreciate it if you would let us know what else is important to you.
Members of the new GMP-Auditor Association will get free access to an online version, participants of this GMP-Auditor Forum will also receive a hard copy of the first version.

Membership will be free! We will keep you informed.

Programme

GMP-Auditor Forum

Seminar Programme as PDF

Introduction to the new ECA GMP-Working Group and the GMP-Auditor Good Practice Guide
  • Brief history
  • Members
  • Output so far
  • Possibilities for information sharing
How good Auditors should be trained
  • Content and Design
  • Internal and external training
  • Experience needed
  • Behavior needed
Current Developments
  • What’s new in the world of auditing
  • Inspection trends
  • Current ways of auditing and the future of audits: Onsite, remote, hybrid
  • Agents’ business practices, roles in the market
What are the Inspectors looking for?
  • How do GMP inspectors evaluate a company’s Audit Programme
  • Inspection methodologies/concepts/approaches
  • Expectations for audit days and number of auditors in an audit vs. scope of the audit, type of products and activities to be covered
  • Audit Reports
Auditing in the Middle East and Asia
  • How EU-GMP regulations are implemented (with a focus on the new Annex 1)
  • What auditors from EU could expect
  • Experiences made being a female auditor in some parts – and how to overcome these
Parallel Sessions (Round Table Discussions)

External Information – how to use it
  • Where to get the Information
  • Third Party Audit Reports - sources, validity of the Reports
  • Inspection Reports, 483s, Warning Letters
  • What to learn from it
Special Challenges
  • What to do if Supplier does not allow for an Audit? Or only remote?
  • What to do if Supplier does only allow for a one-day Audit?
  • Supplier is not willing to be audited according to API requirements although product is used as API
The Use of Checklists
A checklist should not be a substitute for proper planning and audit performance. Discuss advantages of using a well-prepared checklist and its limits.
 
The Use of Interpreters
  • How to get good Interpreters
  • Challenges and pitfalls
  • Experience sharing
Supplier Qualification in a changing World
How to qualify suppliers of APIs, raw materials, intermediates, solvents etc.

How to deal with difficult Auditees
  • Limited information provided
  • Documents not provided or very late
  • Tour is not well organised
  • Passive and uninterested representatives
  • SME unavailability

ECA-Member*: € 1790,-
Non ECA Member*: € 1990,-
EU/GMP Inspectorates*: € 995,-
APIC Member Discount*: € 1890,-
GMP Auditor Association Discount*: € 1690,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Further dates on-site
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Further dates online
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Recording
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023