See below for the program for E&L USA 2017
Led by representatives from Smithers Rapra and GlaxoSmithKline
The workshop will focus on leachable risk assessment and therefore a pre-read package on the basics of extractable and leachable with send to delegates in advance of this course, enabling the workshop to devote more time on the technical risk assessment process. The workshop is designed to give practical experience of performing a technical risk assessment to evaluate exposure risk to patients from leachables derived from container closure or manufacturing materials and then use extractable and/or leachable testing as risk reduction activities to meet regulatory expectations.
It will consist of a mixture of short presentations and predominately an interactive element performing a risk assessment on a fictitious medical product. The facilitators from Smithers Rapra, Baxter Healthcare and GSK will assist in the workshop and give the presentations.
The presentations will cover the concepts and themes associated with a science led risk based approach to extractable and leachable testing and its close alignment to concepts of quality by design and lifecycle management aligned to guidance of Drug Product Development (ICHQ8) and Quality Risk Management (ICHQ9).
Interactive element will cover:
The workshop will cover the entire day and will include a light lunch. Please ensure you include your role in extractables and leachables when booking your ticket so teams can be assigned with a diverse mixture of people.
Please note the workshop will run from 9.30am-5.30pm.
Dr. Timothy Robison | Pharmacology and Toxicology Team Leader, CDER of FDA
Dr. Cheryl Stults | Principal of C&M Technical Consulting
Charles Ducker | Principal Chemist/Group Leader of Eurofins Medical Device Testing
Greg Erexson | Senior Principal Research Scientist of AbbVie
Peter Cornelis | R&D Scientist and Business Development of Toxikon
Dan Norwood, Executive Partner, SCIO Analyical and Kate Comstock, Senior Marketing Specialist, Thermo Fisher Scientific
Andrew Feilden, Chemistry Operations Director, Smithers Rapra and Naren Meruva, Principal Scientist, Waters Corporation
David Weil | Senior Application Scientist of Agilent Technologies
Lead panellist: Daniel Norwood, Executive Partner, SCIO Analytical
Kate Comstock, Senior Marketing Specialist, Thermo Fisher Scientific
David Weil, Senior Application Scientist, Agilent Technologies
Gyory Vas, Business Technical Scientific Liason, Intertek Pharmaceutical Services
Kevin Rowland, Laboratory Manager, Jordi Labs
Naren Meruva, Principal Scientist, Waters Corporation
Thomas Egert | Analytical Development of Boehringer Ingelheim Pharmaceuticals
Carsten Worsøe | Principal Scientist Extractables and Leachables of Novo Nordisk
Motoshi Onoda | Research Chemist of Toray Research Center
Roger Pearson | President of Analytical Services of Aspen Research Corporation
Dr. Dennis Jenke | Chief Executive Scientist of Triad Scientific Solutions
James Mullis | Laboratory Manager, Extractables/Leachables and Trace Organic Analysis of PPD
Jonathan Bones | Principal Investigator of National Institute for Bioprocessing Research and Training (NIBRT)
Michael Jahn | Head Forensic Chemistry, Drug Product Services of Lonza
Ven Raman | Principal Scientist/Manager of MilliporeSigma (Merck)
Ina Pahl | Senior Scientist of R&D of Sartorius Stedim
Raymond Colton | Founder and President of VR Analytical
Both the USP and BPOG have recommended protocols for extractable testing for product contact materials including single use systems (SUS). This presentation compares the two test regimens using sterile filters and then presents additional test results that were performed to explain some of the unexpected differences in the results.
Gyorgy Vas | Business Technical Scientific Liaison of Intertek
Desmond Hunt | Principal Scientific Liason of U.S. Pharmacopeial Convention (USP)