Dr. Christian Hösch
Behörde für Justiz und Verbraucherschutz (BJV)
Referent:innen
Stefan Reintgen
Team Connex
Thomas Højsholm Schmidt
CSL Behring
Charis Schmidt
Ferring
Zielsetzung
In this training course you will learn
- How to plan and conduct audits efficiently
- How to face various audit challenges
- What communication techniques are needed
- How you can avoid and solve conflicts
Hintergrund
Initial and continuous professional training for auditors is of utmost importance as the authorities expect highly qualified personnel performing audits. Therefore, 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
- Auditor 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 deepen your skills and knowledge.
Zielgruppe
GMP Auditors from pharmaceutical and API industry.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
How to Optimise the Audit Programme
- Part I: Who needs to be audited
- Legal basis for audits
- Community project: Evaluation of supplier audits in Europe - Part II: The Audit Programme
- How to set up a risk-based audit Programme
- Expectations from a GMP Inspectors point of view - Part III: How to optimise the Programme
- Third Party, Joint- and Shared Audits
- EU-GMP Certificates and CEPs - Part IV: What can go wrong
How to Plan an Audit
- Audit program to audit plan
- Setting audit scope
- Selecting the auditor/team
- Defining roles in the audit team
- Gathering Information
- Preparing an audit plan/agenda
- Interactive part
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.
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.
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
The Auditor – what makes you a good Auditor
- Auditor skills
- Auditor technical Knowledge
- Auditor Training
- Mistakes auditors make
Interactive Sessions on Communication Skills
1. The challenge of appropriate communication
2. How to recognise, understand and solve conflicts
3. Body language
4. Questioning techniques
Suppliers from China, India and South America
1. The challenge of appropriate communication
2. How to recognise, understand and solve conflicts
3. Body language
4. 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 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.
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
| ECA-Member*: | € 2090,- |
| Non ECA Member*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1145,- |
| APIC Member Discount*: | € 2190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified GMP Auditor"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Für Lieferanten: Ausstellungs- und Sponsoringmöglichkeiten
Seminarprogramm als PDF
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