The GMP Auditor Initial and Continuous Professional Training for GMP Auditors

The GMP Auditor Initial and Continuous Professional Training for GMP Auditors

Prague, Czech Republic

Course No 15739


Costs

Non-ECA Members: EUR 1990,--
ECA Members: EUR 1790,--
EU GMP Inspectorates: EUR 995,--
APIC Members (does not include ECA membership): EUR 1890,--

(All prices excl. VAT)

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 Health and Consumer Protection, Hamburg, Germany
Afshin Hosseiny, Ph.D., Tabriz Consulting
Stefan Reintgen, Team Connex

Objectives

In this advanced 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 and leadautitors 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
  • Leadauditor 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 broaden your skills and knowledge.

Please note: The number of participants is limited.

Target Group

New and experienced 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 program: 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
How to become a good Leadauditor
  • 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
Suppliers from China, India and South America
  • How to prepare audits abroad
  • Challenges and pitfalls
  • Typical compliance issues: what to look for
  • Cultural particularities
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.

Interactive Sessions: Communication Skills
1. The challenge of appropriate communication
2. How to recognise, understand and solve conflicts
3. Body Language
4. Questioning Techniques

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.

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