. ICH Q7 WEEK .

ICH Q7 Auditor Training Course

Date: 02 - 04 December 2020


Wednesday


CONDUCTING AN AUDIT – TOOLS AND TECHNICAL ASPECTS

CEFIC / APIC’s activities and Workgroups – QP demands for an API audit – APIC’s Third Party Audit programme

  • 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 between 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

Audit Sessions
1. How to prepare for specific audit situations
2. How to write an audit report
3. How to classify observations

You will work on questions and case studies concerning these topics.

These audit sessions are supposed to be a knowledge assessment. This assessment is only relevant for participants intending to obtain the APIC Auditor Certification.


Thursday


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
  • 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 Don'ts
  • 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-ended and close-ended questions
  • Other questioning techniques
  • Exercise

Attitude and behaviour in front of the auditee


Friday


The Audit closing meeting and measuring success

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

Conducting an Audit - Remote or Onsite
During these sessions the speakers will explain the differences and commonalities of onsite and remote audits and will point out the advantages and disadvantages of each kind of audit set up.