ICH Q7 Auditor Training Course - Live Online Training
20-22 November 2024
Course No. 21210
Speakers
Francois Vandeweyer
VDWcGMP Consulting
All times mentioned are CET
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, Q11 and the ICH Q7 Q&A Document.
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
Take advantage of combining one of the ICH Q7 Courses with the Auditor Training Course and receive the ECA Certifcate “QA Manager and Auditor for APIs”.
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.
As the number of participants for the Auditor Training Course is strictly limited early booking is recommended!
Target Group
These Live Online 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.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Participants intending to obtain the APIC Auditor Certification: The Role Plays are mandatory for all participants intending to obtain the APIC Auditor Certification. Due to this fact, please make sure that you will have a webcam, microphone (preferably headset), a constant internet connection (preferably via LAN) and join the Webex session via the Webex Application (not via the temporarily browser application). Please note that during the Role Plays other participants will be able to view your chosen name, see your picture and hear your voice.
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
Audit Sessions
How to prepare for specific audit situations
How to write an audit Report
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.
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
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.
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
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.
Written Exam only for participants intending to obtain the APIC Auditor Certification
You will have to answer questions about GMP topics derived from ICH Q7 in a written exam. After having passed successfully this exam, you will be required to take another exam on current GMP topics as an internet-based multiple choice test, approximately 2 weeks after the course. The access code will be made available via email. After having passed this test successfully, you will receive 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