Introduzione

Aseptic processes are necessary in sterile product manufacturing, when terminal sterilization is not suitable, for example, because of intrinsic product features (heat-sensitive).

In pharma and biotech manufacturing, aseptic process simulation (APS), or Media Fill, is essential for validating aseptic processes, by demonstrating the maintenance of sterility during the activities.
As APS plays a crucial role in ensuring the safety and quality of sterile products, it is an increasing focus of regulatory requirements and inspections.

Media Fill runs should simulate as closely as possible the routine aseptic manufacturing process as well as the worst-case scenarios.
It is often challenging to interpret the regulatory requirements and understand how they can be applied practically.

This course aims to describe and address the crucial aspects to be considered in the design of an effective aseptic process simulation, including the risk-based approach, staff qualification, environmental monitoring, and cross-functional cooperation to build a robust and compliant successful APS program.

Areas covered in the training:

  • Introduction to APS principles
  • Regulatory requirements
  • APS design including various process variations
  • Risk management approach

Anyone working in the (bio)pharmaceutical industry, involved in Media Fill runs and willing to learn about the basic principles of APS design, performance, and results management.
In particular, personnel working in Production, Quality Assurance, Quality Control and Validation departments.

The online workshop will be a mixture of theoretical presentations and practical examples.

Docente/i
Ann Van Campenhout
Info

Ann Van Campenhout

Quality Management Expert – QbD Group

Ann van Campenhout has a PhD in Biomedical Sciences and has worked in the Life Science sector for almost twenty years. She has worked as a scientific researcher in an academic stem cell facility at the University Hospital of Leuven for several years. This resulted in the responsibility to set up an ATMP production following the required GMP principles and including APS. After this, she has worked in consultant roles as quality officer for IVF medical devices (Gynetics) and compliance specialist in a beauty product company (Estée Lauder Companies). Currently, she is working on projects involving quality and material, science and technology transfer within a pharmaceutical company (Janssen Beerse).


Ines Taes
Info

Ines Taes

Senior Life Science Consultant – QbD Group

Ines Taes has a PhD in Biomedical Sciences and has worked in the Life Science sector for over ten years. She has worked for two years at GlaxoSmithKline Belgium as a Quality Technology Transfer Manager in External Supply. In this role, she was responsible for the GMP and regulatory compliance through the transfer projects, including APS at the CMO. Prior and after to this, she has worked several years in the Life Science sector, as Technology Transfer Engineer at Alcon (Pharmacy), as Industrialization Expert at Biocartis (In Vitro Diagnostics), and as Product Engineer at Terumo Europe (Medical Devices).


Online Training – 1 module

Module 1 | 15 October 2024 from 1:30 pm to 5:30 pm CEST

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 512,00* (until 24 September 2024)

Ordinary: € 642,00*

Freelance – Individual – Academy – Public Administration**: € 384,00*

*for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Registrati
Early bird
Acquistabile fino al 24/09/2024
512,00
Ordinaria
Acquistabile fino al 14/10/2024
642,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 14/10/2024
384,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the basic principles of APS
Risultato atteso
Interpret and apply the regulatory requirements of APS
Risultato atteso
Take into account key points in the design of an effective APS
Risultato atteso
Manage APS failure and successive investigation

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>