Live Online Training: The GMP-Auditor

Live Online Training: The GMP-Auditor

Course No 18315

All times mentioned are CET.

Costs

ECA-Member: EUR 1490,--
Non ECA Member: EUR 1690,--
EU/GMP Inspectorates: EUR 845,--
APIC Member Discount: EUR 1590,--

(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 training course you will learn
  • How to plan and conduct audits efficiently
  • How to face the current 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:
  • ƒExpectations of the authorities ƒ
  • Audit types ƒ
  • How to deal with travel restrictions ƒ
  • Risk-based audit planning ƒ
  • Audit plan and audit team ƒ
  • Audits in China, India and South America ƒ
  • Categorisation of audit findings ƒ
  • Communication Skills ƒ
  • Conflict solving

Target Group

GMP Auditors from Pharmaceutical and API Industry.

Technical Requirements

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.

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
Remote Audit/ Distant Assessment
  • What are the regulations saying?
  • Remote Audit or Distant Assessment?
  • Benefits, limits, risks
  • Integration in Supplier Qualification System
  • Comparative study to what extent findings in an on-site audit would also be made in a distant assessment
Case Studies: Categorisation of various Audit Findings
  • Examples of audit situations and findings
  • How to evaluate the given examples
  • Possible follow-up activities
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 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

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