Webinar Series on Impurities: Impurities Coming from Supply Chains

Webinar Series on Impurities: Impurities Coming from Supply Chains

Course No 18178

Important: Deadline is 12.00 noon on 13 July 2020

You will find all webinars of this series in this overview

Costs

Registration is no longer possible. Please contact us if you would like to order a recording:

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

Speakers

Jürgen Martin, Martin Consulting, Germany

Background

Pharmaceutical products are typically distributed within a network of global supply chains between API-, excipient- and packaging material suppliers and sites in pharmaceutical industry. It is one key part of GMP-activities to make sure impurities coming from the supply chain are managed adequately to avoid any product quality risk. Currently elemental impurities (covered by ICH Q3D Guideline) but also Nitrosamines (covered e.g. by EMA documents published in September 2019) are in the focus of the authorities. To manage these challenges risk management according to ICH Q9 guideline is a common and helpful tool to be in compliance for such topics in an efficient and ongoing way.

Target Group

The webinar addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://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 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

In this webinar you will get to know how the risks of contamination associated with supply chains can adequately be evaluated. The following aspects will be addressed:
  • Process mapping to understand impact factors to product quality
  • Risk measurement and evaluation of process steps according to ICHQ9
  • Vendor audits as important activity for processes knowledge and to monitor the quality level
  • Vendor complaint tracking as important source for quality Level evaluation
  • Definition of adequate in-house testing programs for impurities
  • Risk based approach for supplier quality evaluation
  • Defining mitigation activities (e.g. adjusted sampling and testing approach)
  • Software support for information tracking
In order to illustrate the causal relations some case studies will be provided.

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