ICH Q7 Auditor Training Course
Wednesday Afternoon
CONDUCTING AN AUDIT – TOOLS AND TECHNICAL ASPECTS
CEFIC/APIC’s Activities and Working Groups – 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
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
Preparation for the Role Plays
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 Audits
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.
