The GMP Auditor

The GMP Auditor

Vienna, Austria

Course No 18852

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

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

Costs

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

(All prices excl. VAT)

* 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
Afshin Hosseiny, Ph.D., Tabriz Consulting
Stefan Reintgen, Team Connex
Thomas Højsholm Schmidt, Leo Pharma

Objectives

In this 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

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
  • Risk-based audit planning
  • Audit plan and audit Team
  • Audits in China, India and South America
  • Categorisation of audit findings
  • Auditor skills and technical knowledge requirements
  • Communication Skills
  • Conflict solving
In a special Audit Simulation Workshop with role plays and video feedback, you will be able to deepen your skills and knowledge.

Target Group

GMP Auditors from Pharmaceutical and API Industry.

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
Workshop: Categorisation of various Audit Findings
Based on typical audit situations and real case studies, proposals on how to evaluate the given examples will be developed in small working groups. Possible follow-up activities will be discussed.

What makes a Good Auditor?
  • Auditor skills
  • Auditor technical knowledge requirements
  • Auditor training
Top 10 Mistakes Auditors make and how to avoid them
  • Poor planning
  • Understanding the local culture and language
  • Being led by the Hosts
  • Following hobby horses (wasting time)
  • Focus on minor issues missing the big problems
  • Accept what they hear - not verifying the Facts
  • Poor record keeping – no evidence to refer to
  • Not knowing the requirements
  • Lack of understanding the process they are auditing
  • Poor communication and reporting of findings
  • Including Examples of audit findings:
    - As reported
    - As it should have been reported
Interactive Sessions: Communication Skills
1. The challenge of appropriate communication
2. How to recognise, understand and solve conflicts
3. Body Language
4. 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 Simulation Workshops
  • Role plays
  • Video Feedback
Selected working groups will simulate pre-defined Audit situations. The experience and performance will be evaluated and discussed with the team.

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

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