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.
Objectives
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.
Programme
Conducting an Audit – Tools and Technical Aspects
- 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
Interacitve Audit Sessions
- How to prepare for specific audit situations
- How to write an audit report
- How to classify observations
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
- 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
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.
Costs
| ECA-Member*: | € 2090,- |
| Non ECA Member*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1145,- |
| APIC Member Discount*: | € 2190,- |
(All prices excl. VAT). Important notes on sales tax.
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This course is part of the GMP Certification Programme "ECA Certified API Production Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
Testimonials
