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Live eLearning - PDA 716 Bio/Pharmaceutical Filtration Process Validation

Jun 16, 2020
1:30 PM
-
3:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online
Closed

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 qualification
  • Regulatory requirements of filter validation
  • Process validation of sterilizing grade filters

Topics to be addressed include:

  • Filter manufacturers’ qualification steps
  • Qualification documentation
  • Regulatory needs and guidances
  • Process validation activities, including viability testing, product bacteria challenge test, extractable/leachable testing, and other important tests

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 validation choices
  2. Address regulator and regulatory requirements relevant to critical and non-critical filtration processes
  3. Review key parameters for secure and reliable filtration processes
  4. Justify your filtration activities

Who Should Attend

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

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

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

Registration Fees

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

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