Speakers
Dr Christian Hösch, GMP-Inspector, Ministry of Health and Consumer Protection, Hamburg, Germany
Afshin Hosseiny, Ph.D., Tabriz Consulting
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
Setting out audit objectives
Selecting the audit team
Assigning objectives to the audit team
Performing audit and monitoring progress
Summarising findings and feedback to the auditee
Follow up and closing the loop
How to become a good Leadauditor
Auditor skills
Auditor technical knowledge requirements
Auditor training
Audit Types
Manufacturing site GMP audits
Wholesalers and distribution centres
Due diligence audits
Pre-inspection audits
Examples of audit findings
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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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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