Aseptic Process Simulation (APS) / Media Fills - Live Online Training
26/27 September 2024
Seminar-Nr. 21331
Referent:innen
Dr. Florian Witte
Boehringer Ingelheim
Dr. Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Luigi Scaffidi
Boehringer Ingelheim Pharma
Note: All times mentioned are CEST.
Zielsetzung
During this course you will learn in lectures and workshops
The new requirements of the revised EU Annex 1
How to plan a media fill in compliance with European and US GMP requirements,
How to interpret the results of a media fill,
How to investigate deviations and define follow-up measures and
How QA should be involved
Hintergrund
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?
Zielgruppe
This Education course is directed at staff from
Production
Quality Assurance
Microbiological Quality Control
who are responsible for the planning and evaluation of Aseptic Process Simulation (Media fill) programmes.
It is also valuable for decision makers who have to deal with Process Simulation data within the framework of production release and Aseptic Process Validation.
Technical Requirements
For our Live Online Training Courses 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.
Teilnehmerstimmen - das sagen andere über unsere Seminare:
„"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen. Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.” Christian Wagener, WAGENER & CO. GmbH GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023