GMP-Auditor Practice An advanced Auditor Course with many interactive Sessions and practical Examples

GMP-Auditor Practice

Barcelona, Spain

Course No 20591

This course is part of the GMP Certification Programme "ECA Certified GMP Auditor". Learn more.

 

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Costs

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If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Energy Kristina Hansen, Ferring, Denmark
Ágnes Kis, form. GMP-Inspector at OGYÉI, Hungary
Christof Langer, OSConsulting, Austria
Thomas Højsholm Schmidt, CSL Behring, Switzerland

Objectives

You will have the possibility to learn and intensively discuss
  • how to focus on specific GMP related aspects
  • how to act and react in an audit

Background

Continuous professional training for auditors and lead auditors is of utmost importance as the authorities expect qualified per- sonal 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 com- pany and the auditee.

Recognising this need for further professional knowledge devel- opment, the ECA Academy has set up this practice-oriented course which is also part of ECA’s Certified GMP Auditor Pro- gramme.

Target Group

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

Programme

The Root Cause of Poor Personnel Related Discrepancies
  • ƒ Introduction – humans are rational!
  • ƒ An explanation for undesirable behaviour
  • ƒ Utilising behaviour science models to change behaviour
  • ƒ A brief explanation on Nudging and Behavioural Design
How to Audit Quality Systems
  • ƒ What should be included in a Quality System’s audit
  • ƒ Pitfalls when auditing Quality Systems
  • ƒ How to detect Quality System issues
How to Audit Production of Solid Dosage Forms
  • ƒ Risk-based approach
  • ƒ Key points to consider
  • ƒ Exercise with role play
How to Audit Production of Sterile Dosage Forms
  • ƒ Key essentials and points to consider
  • ƒ Case studies
How to Audit Data Governance and Data Integrity
  • ƒ Examples of data governance and data integrity issues
  • ƒ Implications of data integrity issues
  • ƒ Auditors role in data integrity governance
  • ƒ Developing a data integrity audit program – “Hands-on Approach”
How to Perform an API Site Audit
  • ƒ 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
  • ƒ Sample receipt and registration
  • ƒ Sample preparation
  • ƒ Equipment Calibration and Maintenance
  • ƒ Reporting
How to Audit Engineering and Technical Operations
  • ƒ HVAC systems
  • ƒ Water systems
  • ƒ Utilities
    - Pressured air
    - Clean steam
    - Special gases
  • ƒ Room qualification
  • ƒ Facility Layouts
  • ƒ Flow of material and waste
How to Audit Microbiological Laboratories
  • ƒ Where to look at
  • ƒ Interpretation of microbiological Data
  • ƒ Examples
How to Deal with Challenging Personalities in the Audit Room
  • ƒ Introduction: people are strange!
  • ƒ Top 10 most frustrating, difficult, or annoying personalities in an audit and how to deal with them

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