The GMP Auditor - Live Online

The GMP Auditor - Live Online

Seminar Nr. 19079

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.

Kosten

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

Alle Preise zzgl. MwSt.

* auch unkompliziert per Kreditkarte bezahlbar American Express Visa Mastercard

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
Afshin Hosseiny, Ph.D., Tabriz Consulting, U.K.
Stefan Reintgen, Team Connex, Germany
Thomas Højsholm Schmidt, Leo Pharma, Denmark

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

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.

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
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 you hear - not verifying the Facts
  • Poor record keeping – no evidence to refer to
  • Not knowing the requirements
  • Lack of understanding the process
  • Poor communication and reporting of findings
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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