Smithers Rapra extractables and leachables expert Dr Andrew Feilden will be giving a live-briefing and Q&A on 21 February 2012 at 10am GMT (London).
The 90 minute online session will show participants how to demonstrate that there are no harmful substances generated as a result of interaction with drug delivery devices and processing equipment. Registration and more details can be found on the Smithers Rapra website.
Dr Feilden has extensive experience in extractable and leachable testing and the selection and assessment of materials for medical and pharmaceutical applications.
Together with a clear introduction to the subject, participants will learn about best practice in generating test results and data to support successful regulatory submissions to both the FDA and EMEA - information that could save organisations both time and money.
The session will cover:
- Introduction to and definition of extractables and leachables
- Regulations, guidelines and recommendations - who is asking for what testing
- When, why and what testing should be done?
- An example of failure mode effects analysis (FMEA)
- Q&A session with Dr Andrew Feilden
The webinar offers key information for: medical device and pharmaceutical product R&D, design, engineering, manufacturing and quality professionals; pharmaceutical product packaging and labelling R&D / material-selection professionals; and manufacturers of components for use in pharmaceutical manufacturing processes.
For more information please contact Gill Tunnicliffe on +44 (0) 1939 252408 or at gtunnicliffe@rapra.net.
