Charis Schmidt
Entourage
Referent:innen
Dr. Christian Hösch
Behörde für Justiz und Verbraucherschutz (BJV)
Stefan Reintgen
Team Connex
Thomas Højsholm Schmidt
CSL Behring
All times mentioned are CEST.
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
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.
Programm
Gesamtes Programm als PDF herunterladen
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.
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.
| ECA-Member*: | € 1990,- |
| Non ECA Member*: | € 2190,- |
| EU/GMP Inspectorates*: | € 1095,- |
| APIC Member Discount*: | € 2090,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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