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.
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
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.
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 Training
How to become a good Auditor
Essentials auditor skills
Auditor pitfalls and how avoid them
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
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
Teilnehmerstimmen - das sagen andere über unsere Seminare:
„"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen. Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.” Christian Wagener, WAGENER & CO. GmbH GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023