Online Vaccine Production Academy – Module 6 Single Use Equipment in Vaccine Production

This interactive Online Vaccine Production Academy, consisting of 8 modules, will teach you all about the different steps of vaccine production, batch release and development.

Duration
3 hrs
Course fee
€ 425 (excl. VAT)

Short description

Module 6 of the Online Vaccine Production Academy will cover the use of single-use equipment in vaccine production. The training is set up in collaboration with Pall Biotech and will be given by the experts of Pall Biotech. It covers the following topics:

  • Single-use vs stainless steel platforms in downstream processing             
  • Integrity of SUT (leak testing, integrity testing, helium integrity testing)    
  • Validation around SUT (leachables & extractables, quality by design, risk management approach)

All the modules will be presented in a particularly interactive way. So not just listening, but active participation is encouraged and facilitated. Where possible, movies, quizzes, polls and live demonstrations of production steps in the cleanrooms of Biotech Training Facility are incorporated. Regulatory requirements will also be taken into account within the different modules.

In addition, there will be ample time to ask questions during the live Q&A sessions of each module. 

If you would like to receive more information about Pall's expertise, products and services, please feel free to contact Biotech Training Facility. See also the privacy policy of Pall.

Objectives

After following Module 6, you have gained knowledge on:

  • Advantages and disadvantages of single-use equipment
  • Differences between single-use equipment, stainless steel and disposable equipment
  • What the basic process impurities (leachables and extractables) are when using single-use equipment
  • Requirements when single-use equipment is introduced, such as validation, impurity profiles and requirements of raw materials

Target group

Everyone who is interested to learn about different vaccine production and all that it entails. 

At least relevant for but not limited to:

  • Employees of QA, QC, Manufacturing, R&D
  • GMP Inspectors
  • Dossier Assessors
  • Consultants

Program

Module 6

14:00

Introduction

14:05

Differences between single-use technology and stainless steel, pro’s and con’s                                                      

15:05

Short break

15:10

Integrity of single-use systems - leak testing and HIT (Helium Integrity Testing) technology

15:55

Short break

16:00

SUT (leachables & extractables, quality by design, risk management approach)

16:30

Live Q&A

17:00

Evaluation & Close out

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

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Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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