Jens Brillault, CU Chemie Uetikon GmbH, Germany
Markus Dathe, F. Hoffmann-La Roche, Switzerland
Ralf Gengenbach, gempex, Germany
Paul Lopolito, Steris Corporation, USA
Stephan Löw, CSL Behring, Germany
Peter Mungenast, Merck KGaA, Germany
Frank Sielaff, GMP Inspector, Regional Authority, Darmstadt, Germany
Paul Stockbridge, Stockbridge BioPharm Consulting, UK
Walter Tabotta, ViruSure GmbH, Austria
Francois Vandeweyer, VDWcGMP Consultancy, Belgium
Peter C. Zimmermann, Iskom, Germany
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
- 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!
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.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer 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: For the Role Plays, 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).
Conducting an audit – tools and technical aspects
CEFIC / APIC’s activities and working groups – QP demands for an API audit – 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
„ Supplier Qualification, supplier classification
„ GMP Risk Factors
„ Regulatory Expectations of Auditing
„ Risk based Audit Model for Suppliers
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.
Conducting an audit – Communication and Psychological Aspects
„ 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
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
„ Differences in body language
„ Different rituals
„ Different Dos and Don’ts
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
„ Open-ended and closed-ended questions
„ Other questioning techniques
Attitude and behaviour in front of the auditee
Preparation for the Role Plays
Conducting an audit – Communication and Psychological Aspects
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, approx. 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.