Online Vaccine Production Academy – Module 4 Formulation & Filling

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 4 of the Online Vaccine Production Academy will cover the formulation & filling stage of vaccine production and includes the following topics:

  • Gowning class B & A 
  • Dilution/formulation
  • Sterile filtration
  • Preparation of vials, stoppers and caps (movie)
  • Filling - by hand and automatic filling line
  • Filling - Isolator and RABS technology
  • In process: weight checks
  • Stability (holding times & shelf life)

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. 

Objectives

After following Module 4, you have gained knowledge on:

  • All the handling and production steps during formulation and filling of a vaccine
  • Gowning and behavior when working under class B & A
  • Different ways of filling a vaccine
  • Stability of a vaccine during production and as a final product

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 4

14:00

Short Introduction

14:05

Gowning class A&B, process overview, sterile filtration (several options), preparation of vials, caps and stoppers and Q&A

14:50

LAF and aseptic work, filling - Isolator and RABS technology, by hand and automatic filling line, vials and syringes (components), speed of filling, preparation of vials, stoppers and caps, in process controls: weight checks during fill and Q&A

15:20

Short break

15:30

Live demonstration automatic filling line

16:00

Short break

16:10

Sampling plan in general, final drug product for release testing and Q&A

16:25

Case study via break out session

16:50

Overall Q&A

17:00

End

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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

Need help? Have a question or a suggestion maybe?

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

Thanks