The GMP-Auditor - Live Online Training Initial and Continuous Professional Training for GMP Auditors

21-23 November 2023

Seminar Nr. 20508

This course is part of the GMP Certification Programme "ECA Certified GMP Auditor". Learn more.

All times mentioned are CET.

Click here to have an overview of all dates for this training course.

Unser Seminarservice

Kosten

*ECA-Member:**	EUR 1790,--
*Non ECA Member:**	EUR 1990,--
*EU/GMP Inspectorates:**	EUR 995,--
*APIC Member Discount:**	EUR 1890,--

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

Zur Anmeldung

* auch unkompliziert per Kreditkarte bezahlbar

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Christian Hösch, GMP Inspector, Ministry of Justice and Consumer Protection, Hamburg, Germany
Stefan Reintgen Team Connex, Germany
Charis Schmidt, Entourage, Germany
Thomas Højsholm Schmidt, CSL Behring, Switzerland

Zielsetzung

In this Live Online training course you will learn

How to plan and conduct audits efficiently
How to face the various challenges
What communication techniques are needed
How you can avoid and solve conflicts
Best practices for audit report writing

Hintergrund

Initial and continuous professional training for auditors is of utmost importance as the authorities expect highly qualified personal performing audits. Therefore the ECA has developed the programme at hand to give you a detailed overview about important matters to consider and to discuss important tasks and challenges like:

Expectations of the authorities
Audit types
How to deal with travel restrictions
Risk-based audit planning
Audit plan and audit team
Audits in China, India and South America
Categorisation of audit findings
Audit report writing
Communication Skills
Conflict solving

Zielgruppe

GMP Auditors from Pharmaceutical and API Industry.

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.

Programm

How to optimise the Audit Programme

Community project: evaluation of supplier Audits in Europe
Who needs to be audited
Things to consider when setting up a risk based Audit programme
GMP Certificates and CEPs
Third Party, Joint- and Shared Audits
Expectations of the authorities
Examples: what can go wrong

How to plan an Audit

Preparing your audit Programme
- Criteria for setting priorities
- Resource planning
Setting and agreeing audit objectives
Selecting auditor team and assigning objectives to auditors
Defining roles in an audit team
Performing the audit and monitoring Progress
Summarising the findings and how to feedback to auditees
Follow up and closing the loop

Distant Assessments and the Combination with on-site Audits

Distant assessments as part of the overall supplier qualification System
Possibilities and limits of Distant Assessments
Distant assessments in combination with on-site audits
Tips for technical implementation

Case Studies: Categorisation of various Audit Findings

Examples of audit situations and findings
How to evaluate the given examples
Possible follow-up activities

The Auditor – what makes you a good Auditor

Auditor Training
How to become a good Auditor
Essentials Auditor Skills
Auditor pitfalls and how avoid them

Communication Skills

The challenge of appropriate communication
HBDI® (Herrmann Brain Dominance Instrument)
How to recognise, understand and solve conflicts
Body Language
Questioning Techniques

Suppliers from China, India and South America

How to prepare audits abroad
Challenges and pitfalls
Typical compliance issues: what to look for
Cultural particularities

Audit Report Writing

How to take proper audit notes
Best practices for audit report writing
- Using standardised report templates
- How to generate a clear and concise list of findings
- Phrases that should be avoided
- Purpose and conclusion
When is a report final?
Timelines for finalisation, distribution, feed-back and follow-up
Difference between internal and external audit report

Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.

Each delegate will get a free HBDI® (Herrmann Brain Dominance Instrument) test.
Understanding oneself better leads to a better understanding of others and to better audits. The HBDI model will be discussed in the course; participation in the test is voluntary.

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