Integrity Test Training Courses - Ireland 2011

 

はじめに

フィルターの完全性試験を正確に行うことは、効率的で安全な医薬品の製造および規制への準拠を保証する上で重要です。Effective training of personnel to assure an understanding of the skills and competencies related to integrity testing is also critical.International GMP regulations require that personnel should receive training appropriate to the duties assigned to them, and continuing training should be given.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.This training has been established to accommodate organisations that have a preference for training sessions away from their own site.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.

Course Description

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.

特長と利点

  • Courses designed and led by experts in pharmaceutical and biotech applications
  • Ensures optimal use of training budgets
  • Held at Pall or Pall-approved training facilities
  • Pall staff can work with you to ensure the course meets specific requirements

Who Should Attend

  • Manufacturing operators, supervisors and managers who require a working knowledge of integrity testing
  • QA/QC staff

Course Content

Courses are delivered with similar structure to on-site trainings and are composed as follows:
  • Overview of Filtration
    • Filter Purpose
    • Filter Construction
    • Lot Number
  • Integrity Test Basics
  • Why Integrity Test?
    • Test Requirements
    • Regulatory Requirements
  • Types of Integrity Test
    • Destructive Tests 
      • Bacterial Retention
      • Non-destructive Tests
      • Bubble Point
      • Forward Flow
      • Water Intrusion Testing (WIT)
  • Troubleshooting (Forward Flow/Bubble Point Tests)
    • What To Do
    • Industry Reference (PDA) Decision Tree
    • Pre/Post Use Recommendations
  • Water Intrusion Test (WIT) 
    • Why WIT?
    • Concept and Correlation
    • トラブルシューティング
  • Summary/Wrap Up of Basic Training Session (“pre-practical summary")
  • Integrity Test Instrument Training
  • Discussion/Q&A

Course Objectives

The course delivery and content is customized to ensure that attendees:
  • 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

Additional Notes

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

Certificate of Training is included for all attendees who have successfully completed the course.

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
アイルランド

Dublin Training Location – 2nd June 2011

National Insititute for Bioprocessing Research and Training (NIBRT)
Engineering Building
Fosters Avenue
Belfield
Dublin 4
アイルランド

Remaining 2011 Dates

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

Course Duration

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

費用

Pall provides a fixed price in advance.The final invoice provides detail on items such as labor, materials, etc.

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

参考文献

Download the event brochure:

 Integrity Test Training Courses - Ireland 2011