. ICH Q7 WEEK .

ICH Q7 Auditor Training Course

6 – 8 December 2017, Vienna, Austria

 

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 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

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

 

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: Experience

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