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

The GMP-Auditor - Live Online Training

Course No 21314

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

All times mentioned are CEST.

Costs

ECA-Member*: EUR 1990,--
Non ECA Member*: EUR 2190,--
EU/GMP Inspectorates*: EUR 1095,--
APIC Member Discount*: EUR 2090,--

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

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

Objectives

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

Background

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

Target Group

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.

Programme

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
Hybrid Audits: 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
  • 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.

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