Course | Extractables & Leachables - Part 1 |
Trainer | Dr. Norbert Handler RD&C Research, Development & Consulting GmbH Dr. Helmut Buschmann RD&C Research, Development & Consulting GmbH |
Period | 08/05/24 |
State | scheduled |
Category | Webinar |
Language | English |
Free places | |
Fee | €395.00 plus VAT. |
Book for myself | Book for group |
Over the last years, the requirements for the assessment of substances that could leach into the drug substance and drug product in the course of its life cycle have increased considerably.
The specific kinds of extractables/leachables can vary from organic oligomers and catalyst residues to heavy metals – to name only 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. Therefore, the ICH is currently working on a new ICH Q3E Guideline for Extractables and Leachables (E&L) to “assist both applicants and regulators by providing focus on critical aspects, and improving transparency in requirements for medicinal products including drug delivery device components”.
Packaging materials have been in the focus of such investigations for a long time as the contact time between drug substance or drug product and packaging material is rather long. But, in addition, other possible sources of contamination also have to be considered. Recently, particular attention has been paid to devices and equipment used in the production process itself, e.g. filters, bags and 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.
This webinar will present the latest developments and the current status of regulatory compliant E&L assessments and cover the following aspects:
Duration: approx. 120 minutes
Language: English | Handout: English
...more from your speaker Dr. Helmut Buschmann...
...more from your speaker Dr. Norbert Handler...
Webinars allow you to conveniently attend training sessions and technical presentations from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.
The modules in this series can also be booked individually. You can find them in our course calendar.
Note on contingent call-off: When booking this single part described here, one part per participant will be deducted.
For whole teams we offer attractive special prices with special advantages or develop your own in-house training for you - please contact us.
Weekday | Time |
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Wednesday | 10:00 - 12:00 |
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