Online Course on Lyophilization / Freeze drying (Live)

This 4 hour live online lyophilization course will teach you all about the lyophilization process, hardware, critical process parameters and regulatory aspects. Certain aspects will be demonstrated live using a pilot scale lyophilizer!

Duration
4 hrs
Course fee
€ 375 (excl. VAT)

Short description

What can you expect from this online lyophilization training course?

This online module on lyophilization covers the following topics:

Introduction in the process of lyophilization: Theory
Lyophilization hardware: where theory meets practical limitations
Translation of product characteristics to a lyophilization process: the lyocycles
Regulatory aspects (interaction with audience expected):

Critical Quality Attributes /Critical Process Parameters
Pharmaceutical development in relation to submitted file
Validation - how to obtain a robust process

This module will be presented in an interactive way. Active participation is encouraged and facilitated. Where possible, video clips, quizzes, case studies and live demonstrations are incorporated.

In addition, there will be ample time to ask questions during the live sessions.

Objectives

After following this course, you have gained knowledge on:

  • what happens during lyophilization with the product and why
  • the critical steps during the lyophilization cycle
  • what parameters are measured during a lyophilization process
  • what parameters are measured on the product after lyophilization is complete
  • how to interpret the process data of a lyophilization process
  • technical background on the hardware of a lyophilizer
  • how a lyophilization cycle is developed
  • regulatory aspects in relation to development
  • the validation parameters of a lyophilization cycle
  • what information needs to be captured in batch records and why

Target group

To whom do we recommend this lyophilization / freeze drying course?

Everyone who is interested in learning the technical, scientific and regulatory background of lyophilization in a GMP environment.

At least relevant for but not limited to:

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

Program

12:30

12:30-12:35 Welcome & Introduction
12:35-13:20 Lyophilization: theory (product characteristics)
13:20-13:25 Short break
13:25-14:10 Lyophilization hardware: theory meets practical limitations
(incl demo)
14:10-14:20 Short break
14:20-14:50 Translating product characteristics to a lyophilization
process: the lyocycle
14:50-15:20 Break out session: case study
15:20-15:30 Short break
15:30-16:20 Regulatory aspects (interaction with audience expected):
o Critical Quality Attributes /Critical Process Parameters
o Pharmaceutical development in relation to submittions
o Validation - how to obtain a robust process
16:20-16:30 Final Q&A and closure

Sign up

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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Know how.
Know why.

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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