An NSF International Company
Workshop – Extractables and Leachables Requirements in Pharmaceutical Development
PrintThis workshop will review the Extractables and Leachables arena and describe the strategies leading companies are taking.
Tuesday 05 March 2026
Minneapolis Marriott City Center, Minneapolis, MN, USA
$950.00 per delegate
Additional delegates from the same site and early bird booking $760.00
Type: Pharmaceutical
About this course
This workshop will provide an overview of E&L with regard to pharmaceutical packaging/container closure systems, processing equipment and devices for drug products including biologics. We will review the regulatory framework and explain why this area is getting so much attention. You will learn about material selection and the risks certain materials present from an E&L standpoint. You will also gain insight into the best practices for E&L testing.
The PQRI Working Group best practices for ‘Orally Inhaled and Nasal Drug Products’ was published in 2006. A similar process is being conducted by PQRI for ‘Parenteral and Ophthalmic Drug Products’ and preliminary approaches were presented in an open forum in February 2011. The workshop will compare and contrast elements of these best practices.
E&L studies generally apply to the selection of components and evaluating changes in components or in their use. This workshop will also illustrate the importance of routine E&L control.
The workshop format will be lecture and casework to involve the participants in tackling real E&L issues and discussing solutions.
The workshop will be of value to development scientists, development engineers, validation scientists, quality control analysts and individuals with quality control and quality assurance responsibilities. Suppliers of components for device manufacturers and disposable biological systems will gain valuable insight. Both N1 and N2 suppliers will benefit. Anyone with E&L project oversight and questions on best practices will benefit by attending this workshop.
