GMP for Beginners in Sterile Manufacturing + Aseptic Process Simulation (APS) / Media Fills - Live Online Training including Case Studies and Exercises

GMP for Beginnners in Sterile Manufacturing
 

The Online Training is designed for people working in sterile manufacturing to get basic knowledge of GMP.

 

Process Simulation / Media Fills
 

During this course you will learn in lectures and workshops

GMP for Beginnners in Sterile Manufacturing
 

Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products and medical devices. Particularly in the manufacture of sterile medicinal products, employees have to comply with extensive requirements. Against this background, employees have to know the GMP requirements and must know how to use them in practice.
The question is: how can employees implement in their daily work regulations which are usually formulated in a very general manner?

 

The aim of the Online Training is to help answer this question and enable the concrete transfer of regulatory requirements into practice. Where are the main difficulties and how can they be solved pragmatically? The Online Training will present elements and situations which employees are regularly confronted with, like for example:

 

Aseptic Process Simulation (APS) / Media Fills
 

In the aseptic processing of medicinal products, the product quality usually cannot be ensured by means of lab controls of the final product. Process validation by means of media fills is the only way to furnish proof of product safety, which is why it justly is the focus of regulatory requirements and official inspections.

A number of revised and harmonised international regulations, especially the FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing“, the EU-GMP-Guide Annex 1, ISO 13408 and the PIC/S Guide „Recommendation on the Validation of Aseptic Processes“, define highly detailed requirements, the implementation of which is critically examined within the framework of official inspections.

In general, the required media fills should be able to simulate both routine operation and worst-case conditions.

In practice, the question of practicability often arises. How should the requirements be interpreted and how can they be implemented even for special production processes or dosage forms?

For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plugin. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.