GMP Webinar: Microbiological Testing of Primary Packaging
Im Auftrag der ECA Academy

GMP Webinar: Microbiological Testing of Primary Packaging Im Auftrag der ECA Academy

Seminar Nr. 16610


Kosten

Die Veranstaltung hat bereits stattgefunden. Suchen Sie nach Wiederholungsterminen und weiteren, themenbezogenen Seminaren auf der Seite GMP Seminare/-Konferenzen nach Thema.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Marcel Goverde, MGP Consulting

Mr Goverde holds a PhD in Biology and runs since 2011 his own company for consulting, training and project management in GMP-relevant areas with focus on microbiology, hygiene and deviation management. He gathered 8 year of work experience in microbiological pharmaceutical industry at F. Hoffmann-La Roche Ltd and another year as QC expert for microbiology at Novartis Pharma. Since 2003 Mr Goverde acts as a Swiss delegate in the EDQM group for microbiological and statistical methods and since 2011 as board member and deputy chair of the ECA Pharmaceutical Microbiology Working Group. He is a regular speaker at different institutions.

Hintergrund

Although microbiological testing of drug products and raw material such as excipient and drug substance are quite clear regulated, hardly any guidance for the testing
of primary packaging is available. Therefore, it is up to the pharmaceutical company to develop a control strategy for microbiological testing of primary packaging as well as to establish suitable methods for testing. This can include to develop the necessary risk assessment and to define the specification for your company and their products..

Zielgruppe

This webinar is made for all persons from

  • Pharmaceutical Manufacturers
  • Manufacturers of Packaging Material
  • Contract Laboratories
  • Authorities
which are involved in development and testing of packaging materials with a special focus on microbiological testing.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.htm 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 plug-in. 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.

Programm

This webinar aims at giving you a comprehensive but still compact overview about the possibilities of microbiological specifications and testing of primary packaging.
It will cover:

  • Regulatory Expectations
  • Microbiological Specifications
  • Testing Methods

Zurück

GMP Seminare nach Thema

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