Integrity Test Training Courses - Ireland 2011

 

Einleitung

Die sorgfältige Durchführung der Filterintegritätstests ist unerlässlich für die Gewährleistung einer effizienten und sicheren Pharmaproduktion und die Einhaltung geltender Vorschriften. Effective training of personnel to assure an understanding of the skills and competencies related to integrity testing is also critical. Nach internationalen Good-Manufacturing-Practice-Richtlinien (GMP) muss das Personal auf kontinuierlicher Basis für die ihm zugewiesenen Tätigkeiten geschult werden. Pall can help you to meet these requirements by
providing high quality training through experienced instructors to assure immediate application of integrity test principles and techniques in your operation. 

Training with Pall

As well as offering complete training at our customers’ production sites, Pall also offers courses at either Pall facilities or other approved locations with predetermined dates, details of which are shown overleaf. Diese Schulung wurde erarbeitet, um Unternehmen zu bedienen, die Schulungen außer Haus vorziehen. Such training offers the advantage of being able to send as many or as few personnel as you want, and at fixed dates and prices to allow for budgetary and future manufacturing planning. It also provides the potential for attendees to network, share their experiences and gain a wider understanding of integrity testing and filter use in the pharmaceutical industry. All courses are run by experts local to your geographic region using dedicated Pall training equipment.

Kursbeschreibung

The Integrity Test Training is an interactive course designed for manufacturing operators and other relevant staff to assure an understanding of the integrity test by conveying the basics of filtration and integrity testing, regulatory requirements, various types of integrity tests, instruments used, troubleshooting and hands-on application.

Eigenschaften und Vorteile

  • Courses designed and led by experts in pharmaceutical and biotech applications
  • Optimale Nutzung Ihres Schulungsbudgets
  • Held at Pall or Pall-approved training facilities
  • Pall staff can work with you to ensure the course meets specific requirements

Wer sollte teilnehmen?

  • Manufacturing operators, supervisors and managers who require a working knowledge of integrity testing
  • Qualitätssicherungsbeauftragte

Kursinhalt

Courses are delivered with similar structure to on-site trainings and are composed as follows:
  • Overview of Filtration
    • Aufgabe der Filtration
    • Filterbauart
    • Chargennummer
  • Grundlagen der Integritätsprüfung
  • Zweck des Integritätstests
    • Testanforderungen
    • Regulierungsvorschriften
  • Arten von Integritätstests
    • Destruktive Tests 
      • Bakterien Rückhaltung
      • Zerstörungsfreie Tests
      • Bubble-Point-Test
      • Forward-Flow-Test
      • Wasserintrusionstest (WIT)
  • Fehlerbehebung (Forward-Flow/Bubble-Point-Tests)
    • Was ist zu tun?
    • Branchenspezifischer Entscheidungsbaum (PDA)
    • Empfehlungen vor/nach dem Gebrauch
  • Wasserintrusionstest (WIT) 
    • Warum ein WIT?
    • Prinzip und Korrelation
    • Fehlerbehebung
  • Summary/Wrap Up of Basic Training Session (“pre-practical summary")
  • Schulung am Filterintegritätstestgerät
  • Diskussion/Fragen und Antworten

Schulungsziele

Der Kurs orientiert sich methodisch und inhaltlich an den Bedürfnissen des Kunden und zielt darauf ab, dass die Teilnehmer:
  • Understand the importance of testing filters for integrity as a critical step in the manufacturing process to make sure that the filter functions as intended
  • Understand how the theory and practice of the range of integrity tests available differ
  • Can apply practical experience of operating manual and automatic integrity test instruments and systems

Zusätzliche Hinweise

Course includes practical session using integrity test instrumentation, as well as a quiz to measure competency and understanding.

Alle Teilnehmer, die den Kurs erfolgreich absolviert haben, erhalten ein Schulungszertifikat.

Location and Getting There

In 2011, we are offering training from two sites in Ireland: the FÁS Biopharm Centre in Co. Cork and The National Institute for Bioprocess Research and Training (NIBRT) in Dublin. These facilities were developed in response to the training needs for the developing and existing industries in the pharmaceutical and biotechnology sector.

The full addresses of the facilities are:

Cork Training Location – 23rd February 2011

FÁS Biopharm Centre
Unit 1
Estuary Industrial Estate
Crosshaven Road
Carrigaline
County Cork
Irland

Dublin Training Location – 2nd June 2011

National Insititute for Bioprocessing Research and Training (NIBRT)
Engineering Building
Fosters Avenue
Belfield
Dublin 4
Irland

Remaining 2011 Dates

  • Thursday 2nd June
    The National Institute for Bioprocess Research and Training (NIBRT), Dublin

Dauer der Schulung

A full day is allocated to Integrity Test Training run from our own facilities.

Kosten

Pall provides a fixed price in advance. In der Abschlussrechnung werden Einzelposten wie Arbeitszeit, Materialien usw. detailliert aufgeführt.

Further Details

For enquiries relating specifically to the course location and dates listed above, please contact your local Pall representative or Donnacha Ryan on +353 (0) 2145 40900 or email donnacha_ryan@europe.pall.com

Ausgewählte Literatur

Download the event brochure:

 Integrity Test Training Courses - Ireland 2011