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Live eLearning - PDA 717 Bio/Pharmaceutical Filter Integrity Testing

Jun 18, 2020
1:30 PM
-
3:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online
Cancelled

Overview

Filtration is used to separate unwanted contaminants both viable and non-viable from fluid streams. Filtration becomes the prevalent sterilization method due to the increase in bioprocess applications. The filter can be a protective unit to prolong the life of other equipment, to reduce the bioburdens or the highly critical last barrier before the vial. The criticality of the performance of the filtration steps shall not be underestimated but require in-depth knowledge to run the filtration processes in a robust and optimal manner. This training course will focus on:

  • Filter integrity testing
  • Regulatory requirements of filter integrity testing, including PUPSIT and the PDA initiatives
  • Trouble shooting of integrity tests

Topics to be addressed include:

  • Non-destructive integrity test correlation to the bacteria challenge test
  • Description and functions of the different integrity tests
  • Regulatory needs and guidances, including an update on PUPSIT and the PDA initiative
  • Points to consider in integrity testing and trouble shooting

The training course format will be lecture with a question and answer session after the presentation.

For more options and/or related training courses, please visit the page(s) below.

PDA Filtration Training Courses

Trainers

Maik W. Jornitz
Maik W. Jornitz
G-CON Manufacturing

Learning Objectives

  1. Make the right integrity test choices
  2. Address regulator and regulatory requirements relevant to when to test and how
  3. Understand what influences integrity tests and what to do when a filter fails

Who Should Attend

This training course is intended for professionals who are responsible for or involved in liquid filtration processes for pharmaceutical/biopharmaceutical processes.

Departments
  • Quality Control
  • Quality Systems
  • Quality Compliance
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Validation
  • Technical Operations
  • Facilities

Roles
  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager
  • Engineer
  • Analyst

Registration Fees

Cancelled
Registration Type Price
Member $200
Non-member $200
Gov't/Health Auth./Academic $200

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