The Ever-Changing World of Extractables and Leachables: Lessons learned and future challenges

Register Free: http://www.chromatographyonline.com/lcgc_w/gmp

Event Overview:

Join global industry and regulatory experts as they discuss current extractables and leachables (E&L) hot topics on pharmaceuticals, biopharmaceuticals, and medical devices. Extractables and leachables are an important consideration when developing medical products and devices. This conference will give you an insight into a number of different topics within the ever-changing world of E&L.

Key Learning Objectives:

• Gain insight to some of the important E&L areas for medical devices and pharmaceutical products
• Learn about some of the key challenges within the field of E&L
• Understand the science behind the testing

Who Should Attend:

• Representatives from the supply chain to pharma, biopharma, and medical devices
• Members of the medical and medicinal product world wanting to know more about the challenges with E&L
• Those new to the field of E&L wanting to learn some key aspects of the requirements

Schedule:

ISO 10993-18: Establishing an AET for Chemical Characterization of Medical Devices

Ted Heise, PhD, RAC – MED Institute, Managing Partner &Toxicologist, D&B ChemTox, LLC

E&L in Biological Combination Products

Alicja Sobantka, PhD, Material Qualification, Octapharma

Managing Change in This Rapidly Changing World of Extractables and Leachables

Nick Morley, Principal Scientist, Hall Analytical

Strategies to Overcome Challenges in Extractable Screening Studies

Rachel Sanig, Senior Scientist, Waters Corporation

What is the Future of Leachables and Extractables Assessment?

Dan Norwood, Principal Consultant, Feinberg Norwood & Associates Pharma Consulting

What next for E&L?- Data, Information, Knowledge to Wisdom

Jason Creasey, Managing Director, Maven E&L Ltd

PANEL DISCUSSION

Qualification of screening methods, how is this achieved?

Speakers

Andrew Feilden
European E&L Strategic Director
Hall Analytical

Ted Heise, PhD
RAC – MED Institute, Managing Partner & Toxicologist
D&B ChemTox, LLC

Alicja Sobantka, PhD
Material Qualification
Octapharma

Nick Morley
Principal Scientist
Hall Analytical

Rachel Sanig
Senior Scientist
Waters Corporation

Dan Norwood
Principal Consultant
Feinberg Norwood & Associates Pharma Consulting

Jason Creasey
Managing Director
Maven E&L Ltd

Sponsors

Hall Analytical
VR Analytical
Waters

Register Free: http://www.chromatographyonline.com/lcgc_w/Hall_Part3