Webinar GDP for APIs

Webinar GDP for APIs

Course No 17903

Important: Deadline is 12 noon on 30 September 2020

Costs

ECA-Member: EUR 199,--
Non ECA Member: EUR 249,--

(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 Nicola Spiggelkötter, Knowledge & Support

Background

Since September 2015, the “Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use” have been obligatory. The driving force behind these Guidelines is the combat against falsified drug substances and drug products. It is intended to control the entire supply chain and thus to mitigate the risk associated with complex distribution pathways. Well trained staff has to ensure that all the requirements of the guidelines are met. In several sections of the Guidelines, it is pointed out that a thorough training of the employees is important.

Target Group

This webinar is designed for all persons from companies involved in the distribution and supply of APIs. Those are e.g. coworkers and high-level personnel from the following industries:
  • API manufacturers
  • API distributors and traders
  • Pharmaceutical manufacturers
  • Logistics companies
  • External warehouses
  • further service providers offering services for the distribution of APIs

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

This webinar aims to give participants a comprehensive yet compact overview of current expectations concerning GDP for APIs.
The topics addressed are:
  • Regulatory requirements and guidance
    • “Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use”
    • “WHO Good trade and distribution practices for pharmaceutical starting materials” 
  • Ensuring compliance with the current requirements
  • EU GDP for finished medicinal products and EU GDP for APIs: Similarities and differences
  • Critical evaluation of individual aspects with regard to GDP for APIs
  • Outlook: Where is the trend heading?

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