ICH Q7 Auditor Training Course

6-8 December 2017

Vienna, Austria

Course No 16099

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

ANDY BAILEY, ViruSure, Austria
RICHARD M. BONNER, formerly Eli Lilly andCompany Limited, UK
RALF GENGENBACH, Gempex, Germany
HOLGER KAVERMANN, Roche Diagnostics, Germany
PETER MUNGENAST, Merck KGaA, Germany
SABINE SCHACHTSCHNEIDER, Roche Diagnostics,Germany
ROB SLOBBE, Philips Image Guided Therapies, The Netherlands
PAUL STOCKBRIDGE, Biopharm Consulting, UK
FRANCOIS VANDEWEYER, Janssen Pharmaceutica,Belgium
PETER C. ZIMMERMANN, Iskom, Germany

Objectives

These education courses have been developed to provide an excellent knowledge of the requirements laid down in ICH Q7. The contents of the guideline will be explained step by step and practical advices will be given on how to fulfil the requirements of ICH Q7. You will also get to know the key principles of risk management, quality systems and development and manufacture of APIs as they are laid down in ICH Q9, Q10 and Q11. For example you will learn

at which stage of production GMP compliance is to be applied
how to comply with GMP hot topics like process validation, reprocessing/reworking, equipment qualification, change control, failure investigation etc,
how to use a risk-based approach within the concept of supplier qualification,
how to link material attributes and process parameters to drug substances CQAs,
what has to be considered in order to be prepared for a GMP inspection.

Choose between two parallel GMP education courses according to your field of interest:
ICH Q7 Compliance for APIs manufactured by Chemical Synthesis
or
ICH Q7 Compliance for APIs manufactured by Cell Culture/Fermentation.

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, the Training Course will provide 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.

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

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

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 – 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

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.

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

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.

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