Taking place from May 9-11 2017 in Falls Church, VA, Extractables & Leachables USA is the world's leading conference dedicated solely to extractables and leachables. The conference covers the regulatory landscape, advances in science and testing methods, the latest technological developments, biocompability, biomanufacturing, BPOG vs. USP, as well as featuring case studies from leading experts in the field.
How attending this conference will benefit you
Extractables and leachables examination is continuously growing in importance. Given the current scruitny paid by governing bodies including the FDA and EMEA, understanding the best practice and guidelines to carry out extractables and leachables studies is imperative in order to eliminate risk and potential development delays.
Smithers Rapra's have been organising both the USA edition and the European edition of the Extractables & Leachables conferences for over 10 years and have a long history of providing regulatory conferences so you can be sure that this conference will not only provide you with the most up to date information but also a great conference experience.
Why you should attend this conference
Taking into account the ever evolving marketplace and changing requirements, we've developed a program that includes leading industry experts from every level of the supply chain. Representatives from Novo Nordisk, the FDA, Agilent Technologies, Toxikon, NIBRT, Boehringer Ingelheim Pharmaceuticals, Lonza and more will present on a number of hot topics from the regulatoru landscape to E&Ls in biopharmaceutical manufacturing. Presentations include:
- Regulatory perspectives for dealing with extractables and leachables in drugs (FDA)
- In-vitro toxicological evaluation of materials: The potential of using an AMES assay for the assessment of the mutagenic risk of extractables from the development of pharmaceutical containers
- A comprehensive analytical workflow for the qualitative assessment of extractables and leachables
- Bridging extractables & leachables - mass transport modelling in support of an optimized study design
- Analytical assessments of degraded polymer products after gamma sterilization and differences of extractables between before and after sterilization
- Application of the BPOG protocol for standardized extractables testing in SUS: A case study for components used in biomanufacturing
- In depth characterization of E&Ls from single use bioreactors: Data, learnings and perspective
View the full programme here >>
Whatever your position and whether you're a from a CRO, pharmaceutical manufacturer, packaging specialist, instrument or equipment manufacturer, research or academic institution, chemical company or OEM - can you afford to miss it?