GMP Webinar: Microbiological Testing of Primary Packaging

GMP Webinar: Microbiological Testing of Primary Packaging

Course No 16610


Costs

Non-Members: EUR 199,--
Members: EUR 149,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

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.

Background

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..

Target Group

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.

Programme

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

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