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
Ines Taes
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).
Siebe Tonnaer
Siebe Tonnaer has a background in microbiology and has worked in the Life Science sector for over fifteen years. He has worked for over 4 years at PharmaCell (currently known as Lonza) in several hands-on roles in an aseptic production facility for autologous cell therapy. After this, he worked for thirteen years in the Life Science sector, in which he had several roles such as Senior operator for aseptic products and aseptic process specialist for IMPs at Basic Pharma manufacturing in the IMP department.
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 30 September 2024)
Ordinary: € 642,00*
Freelance – Individual – Academy – Public Administration**: € 434,00*
*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.
Mara Claudia Algarotti
Training Manager & MW Operations
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
