Online Course on Lyophilization / Freeze drying (Live)

Short description

This course is only available for group registrations of 8 trainees or more. Please contact us at info@biotechtrainingfacility.nl to arrange a date.

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