The ICH Q7 Auditor Training Course will inform you about the general advice on Good Auditing Practices included in the APIC "Auditing Guide" and the APIC Third Party Audit Programme. In addition to the training of the communication skills, you will be provided with assistance on what to focus on during an API audit and on the current "state of the art" from an industry perspective. Moreover, you will learn about the key principles of writing a professional audit Report.
Target Group
These training courses are designed for all persons involved in the manufacture of APIs (either chemically or by cell culture/fermentation), especially for persons from production, quality control, quality assurance, technical and regulatory affairs departments as well as for Qualified Persons and Auditors. We are also addressing interested parties from engineering companies, from the pharmaceutical industry and GMP inspectorates.
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 a 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
Interacitve Audit Sessions
How to prepare for specific audit situations
How to write an audit report
How to classify 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
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 closed-ended questions
Other questioning techniques
Exercise
Attitude and behaviour in front of the auditee
Preparation for the Role Plays
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.
This course is part of the GMP Certification Programme "ECA Certified API Production Manager" Learn more
Testimonials
Seminar Programme as PDF