GMP Auditor Workshop
Im Auftrag der ECA Academy

GMP Auditor Workshop Im Auftrag der ECA Academy

Barcelona, Spain

Seminar Nr. 17511


Kosten

Non ECA Member: EUR 2190,--
ECA-Member: EUR 1990,--
EU/GMP Inspectorates: EUR 1095,--
APIC Member Discount: EUR 2090,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Ágnes Kis, form. GMP-Inspector at OGYÉI, Hungary
Christof Langer, OSConsulting, Austria
Thomas Højsholm Schmidt, Leo Pharma, Denmark
Kristina Smith Hansen, MilCor Consulting, Denmark
Miro Zdilar, Teva Pharmaceuticals, Croatia

Zielsetzung

In this Workshop you will have the possibility to learn and intensively discuss
  •  how to focus on specific GMP related aspects
  •  how to apply appropriate communication skills

Hintergrund

Continuous professional training for auditors and lead auditors is of utmost importance as the authorities expect qualified personal performing audits. And GMP audits of suppliers, contract manufacturers and contract laboratories are a fundamental part of a Quality Management System to assure the quality of a drug product. Only knowledgeable and highly qualified auditors with a profound technical knowledge and good communication skills can guarantee audits that are useful for both the auditing company and the auditee.

Recognising this need for further professional knowledge development, the ECA Academy has set up this workshop as an individual course which is also part of ECA’s Certified GMP Auditor Programme.

Zielgruppe

This workshop is designed for both new and experienced auditors. It can also be seen as an addition to the ECA Course “The GMP Auditor”.

Programm

Kick-off: The Root Cause of poor personnel related Discrepancies
  •  Introduction – humans are rational!
  •  An explanation for undesirable behaviour
  •  Utilising behaviour science models to change behaviour
  •  A brief explanation on Nudging and Behavioural Design
How to audit Quality Systems
  •  What should be included in a Quality System’s audit
  •  Pitfalls when auditing Quality Systems
  •  How to detect Quality System issues
How to audit Production of solid Dosage Forms
  •  Risk-based approach
  •  Key points to consider
  •  Exercise with role play
How to audit Production of sterile Dosage Forms
  •  Key essentials and points to consider
  •  Case studies
How to audit Data Governance and Data Integrity
  •  Examples of data governance and data integrity issues
  •  Implications of data integrity issues
  •  Auditors role in data integrity governance
  •  Developing a data integrity audit program – “Hands-on Approach”
How to perform an API Site Audit
  •  Chemical synthesis
    •  Dedicated vs. multiple purpose facility
    •  Material dispensing
    •  Cross-Contamination
    •  Process and cleaning validation
    •  Utilities
  •  Biotechnology
    •  Cell banks
    •  Inoculation
    •  Fermentation
    •  Harvest
    •  Purification
How to perform Quality Control Laboratory Audits
  •  Sample receipt and registration
  •  Sample preparation
  •  Equipment Calibration and Maintenance
  •  Reporting
How to audit Engineering and Technical Operations
  •  HVAC systems
  •  Water systems
  •  Utilities
    • Pressured air
    • Clean steam
    • Special gases
  •  Room qualification
  •  Facility layouts
  •  Flow of material and waste
How to audit microbiological laboratories
  •  Where to look at
  •  Interpretation of  microbiological Data
  •  Examples
How to deal with challenging Personalities in the Audit Room
  •  Introduction: people are strange!
  •  Top 10 most frustrating, difficult, or annoying personalities in an audit and how to deal with them

Zurück

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