ICH Q7 Auditor Training Course

(Im Auftrag der European Compliance Academy)

ICH Q7 Auditor Training Course <p>(Im Auftrag der European Compliance Academy)

Vienna, Austria

Seminar Nr. 9187


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Richard M. Bonner
formerly Eli Lilly and Company Limited, UK
Francois Vandeweyer
Janssen Pharmaceutica, Belgium
Peter C. Zimmermann
Iskom, Germany


In compliance with the European Directives, Manufacturing Authorisation Holders of Medicinal Products Manufacturers must satisfy themselves that the APIs used as Starting Materials in the manufacture of Medicinal Products are compliant with the ICH Q7 GMP requirements that are included as Part II of The Rules Governing Medicinal Products in the European Union.

Audits are a powerful tool for senior management to meet these requirements and to determine whether a manufacturer is in compliance or not, i.e. to compare „what is in place“ with „what should be in place“.


his training course will inform the participant about the general advice on Good Auditing Practices included in the APIC “Auditing Guide” and the APIC Third Party Audit Programme (www.apic.cefic.org) which is based on the advice of the European Authorities on the Principles of Third Party Auditing. In addition to the training of the communication skills, the ICH Q7
Auditor Training Course will provide assistance on what to focus on during an API audit and on the current „state of the art“ from an industry perspective. The basic document for this part of the training will be the APIC/CEFIC‘s „How-to-Do“ document, an interpretation of ICH Q7 requirements. For becoming a certified auditor within the „ICH Q7 Auditor Certification
Scheme“, it is a prerequisite to have also participated in the ICH Q7 training courses for APIs manufactured either chemically or by cell culture/fermentation (2.5 days each). However, it is also possible to participate in this training course without the aim of certification.

Prerequisites to become an APIC Certified ICH Q7 Auditor

In order to become an APIC Certified auditor the following prerequisites have to be fulfilled:

You should have at least 5 years practical experience of GMP compliant manufacture in the pharmaceutical industry or API industry
You should already have conducted at least 10 external audits in the last 3 years. At least 1 audit per year should have been related to APIs, Intermediates or Starting Materials with ICH Q7 as standard
You have to complete one of the Compliance Courses before you take part in the Auditor Training Course.
You have to pass a written exam directly after the Auditor Training Course
You also have to pass an Internet-based exam appr. two weeks after the Auditor Training Course

This APIC certification is an option and not mandatory for the participation in these courses!


Conducting an audit – tools and technical aspects

The CEFIC / APIC Audit Programme – a Third Party Audit Option – Guidance on Auditing Practice
CEFIC / APIC Quality Working Group
EU Legislation and Advice on GMP Status of Active Substances
Third Party Audit Principles
The APIC Audit Programme
Auditor Certification
Phases of the APIC Audit Programme
Contracts with Auditor and Auditee
Audit Dos and Don’ts
Advance preparations for successful audit
Performing the Audit
Closing Meeting
Audit Report

How to prepare for an audit depending on the scope
How to write an audit report
What makes a good “observation”?
Elements of audit observations
General rules on writing observations
Types of observations
Writing style
Common pitfalls seen in writing observations

Conducting an audit –
Communication and psychological aspects

Training Objectives
Brush-up existing knowledge about communication and leading a conversation
Analysis of the phenomenon of verbal and non-verbal communication
Analysis of the art of questioning and conversation techniques
Reflection on the auditor’s role
Development of questioning and interview techniques
Awareness of possible conflict situations
Feedback and reflection on your own behaviour
Exchange of experiences

Communication Part I

General aspects of communication
The meaning of communication in an audit
Communication as a process
Analysis of the process

Key issues of communication
Verbal and non-verbal communication
The first impression
Determining important aspects in communication

Communication Part II

Multicultural aspects
Differences in body language
Different rituals
Different dos and taboos
Workshop multicultural aspects: Experiences

Audit: A unique situation of communication
The overall setting
The participants
The rules
The topics

Communication Part III

General aspects of opinions and observations
Successful communication
Skills of the listener
Skills of the speaker
Active listening
Objective evidence of GMP Deficiencies directly related to ICH Q7
Classification of Deficiencies

Questioning methods
Open and closed ended questions
Other questioning techniques
Attitude and behaviour in front of the auditee
Preparation for the role plays

The Audit closing meeting and measuring success
Lead auditor’s tasks and behaviour in the closing meeting
Audit summary report
Audit finding categories
Audit response and follow-up audits
Ways to measure the success of an audit


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