Live Q&A – The Analytical Evaluation Threshold (AET)

In case you missed it here is a recording of our live Q&A session AET Determination and how to acheive it.

Join our subject matter experts Dr Andrew Feilden and Nick Morley for an introduction to the AET concept, which is used for both medicinal products (USP1663) and medical devices (ISO10993-18). It covers key areas of determining the AET and approaches for ensuring the AET is greater than the analytical methods Limit of Quantification.

The presentation is followed by a 30 minute question and answer session where the merits of various options can be discussed and debated.

 


Speakers

Nick Morley, Principal Scientist, Hall Analytical

Nick has over 12 years of experience in the field of extractables and leachables, both in large pharma and at a CRO. He is responsible for providing technical/consultative support to new and existing customers in the field of E&L. Experience working on a range of products including pharmaceutical/biopharmaceutical (inhalation, topical and parenteral), medical device and nicotine delivery systems.

Nick has a BSc in Chemistry, is a BSI Committee member and British representative on the CEN (European standards Committee) working group for extractables and leachables of Electronic Cigarettes & E-liquids.

Andrew Feilden. Hall Analytical.

Dr Andrew Feilden is the European E&L Strategic Director at
Hall Analytical. He joined Hall in November 2019 where he is a technical expert in the field of E&L testing undertaking commercial, operational and technical thought leadership activities. He has presented on the field of extractables and leachables in over 16 countries world wide. Andrew has written a number of papers and publications and is the inventor of 2 patents. He has a degree and D Phil from the University of York, is a Fellow of the Royal Society of Chemistry and was a Scientific advisor to IPAC-RS and ex-cochair of ELSIE.

Moderator

Martin Caygill. Hall Analytical.