Live Online Training "Leachables & Extractables" - Current Regulatory and Scientific Developments
2 July 2020
Course No. 18186
Speakers
Gaby Reckzügel
Boehringer Ingelheim Pharma
Dr Armin Hauk
Sartorius Stedim Biotech
Dr Andreas Nixdorf
SGS Institut Fresenius
Objectives
Over the last years, the requirements on the assessment of substances that could leach into the drug product in the course of its life cycle have increased considerably.
The kind of leachable you would have to look for can vary from organic oligomers and catalyst residues to heavy metals – to name a few. Due to the resulting complexity, it is very important to consider the potential risk factors associated with leaching substances already at a very early stage in process development
Packaging materials have been in the focus of such investigations for a long time as the contact time between drug product and packaging material is rather long.
But in addition you have also to consider other possible sources of contamination. Recently, particular attention was paid to devices and equipment used in the production process itself, e.g. filters, bags, tubes. The trend towards single-use equipment might relieve the pressure on cleaning validation and the need to introduce control strategies along the supply chain to avoid unintentional added impurities in materials. At the same time leachables/extractables testing will become a topic of major concern.
Within the scope of this GMP Education Course, all relevant aspects of Pharmacopoeia/GMP - compliant leachables and extractables testing will be addressed ranging from regulatory requirements to routine extractables testing in quality control.
Experienced industry speakers share their in-depth knowledge with you.
Target Group
The course is designed for personnel of pharmaceutical companies and their suppliers who
are responsible for qualification of extractables/leachables in quality control,
perform leachables/extractables testing,
work in quality control of packaging materials,
choose and define polymeric, glass and rubber materials in process development,
choose and define Single Use Equipment for manufacturing,
develop materials sourcing strategies.
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.
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Testimonials
Seminar Programme as PDF