ICH Q7 Auditor Training Course

Programme

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

Applying Quality Risk Management to prepare for an Audit

• Expectations for the content of reports of audits of active substance manufacturers
• Supplier Qualification, supplier classification
• GMP Risk Factors
• Regulatory Expectations of Auditing
• Risk based Audit Model for Suppliers

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
• Exercise

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
• Exercise

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

Interactive Session on ICH Q7
The participants will work on questions regarding GMP topics derived from ICH Q7. The questions and answers will be discussed in a plenary session. More questions will be discussed in working groups and the answers will then be presented in the plenary.

This interactive session is supposed to be a knowledge assessment. This assessment is only relevant for participants intending to obtain the APIC Auditor Certification.

Conducting an Audit – Role Plays
The participants will have the opportunity to manage an audit situation within a role play scenario.

During these role plays a trainer with academic education in psychology assesses the participants’ auditing skills and judges their aptitude for conducting audits.

This assessment is relevant only for participants intending to obtain the APIC Auditor Certification.

Written exam only for participants intending to obtain the APIC Auditor Certification:
The participants will have to answer some questions about GMP topics derived from ICH Q7 in a written exam. After having successfully passed this exam the participants are required to take another exam on current GMP topics as an Internet-based multiple choice test approx. 2 weeks after the course has finished. The access code will be made available via email.

After having passed the Internet-based exam successfully the participants will receive their APIC Auditor Certification via post.