Dr. Feilden will lead a full day pre-conference workshop, May 9, on “Leachable Risk Assessment.” The workshop is comprised of
a mixture of short presentations and an interactive risk assessment on a hypothetical medical product. Presentations will focus on the concepts of quality by design and lifecycle management associated with a science-led, risk-based approach to extractable and leachable testing, while the interactive portion will cover risk identification, risk reduction and risk evaluation and analysis.
“The examination of extractables and leachables continues to grow in importance, and we are proud to be at the forefront of developing best practices and guidelines for these studies,” said Nat Leonard, President, Smithers Rapra. “E&L USA brings together expert knowledge on the latest regulations, compliance and case studies, which Dr. Feilden and Dr. Norwood can speak to with a wealth of experience.”
Dr. Norwood will deliver a presentation on May 10, titled “Extractables and Leachables Laboratory Assessments: From Research Project to Commodity,” which will discuss the lifecycle of a product through development. Following this presentation, Dr. Feilden will speak on “Ion-Mobility Mass Spectrometry and Screening Workflow for Detection and Identification of Extractables and Leachables,” which will cover challenges in positive identification, improving confidence using scientific libraries and the advantages of ion-mobility MS and CCS-based workflow.
As chemistry operations director, Dr. Feilden leads a team of industry experts split over two sites. One site is in Leatherhead, UK and specializes in testing materials for food contact compliance. The other is in Shawbury, UK and carries out extractable and leachable testing for the pharmaceutical and medical industries.
As an independent senior consultant, Dr. Norwood’s expertise strengthens the ability of Smithers’ global team to help clients assess and address a range of material-related challenges with medical, pharmaceutical and food packaging. His work includes the evaluation and implementation of study programs and assisting clients with risk mitigation and regulatory submissions.
Covering medical devices or pharmaceutical delivery/packaging from material to final product performance, packaging integrity and regulatory submissions, Smithers offers a unique set of services that can assist clients through the development process. Extensive technical expertise and a global laboratory footprint supplements this differentiated service offering. Learn more about Smithers’ medical and pharmaceutical testing services here.
About Smithers Rapra:
Smithers Rapra has been a trusted partner of the plastics and rubber industries for over 90 years. Our business is built around delivering a complete portfolio of rubber and plastic testing services to support a wide range of industry sectors including tire, automotive, polymer products, oil and gas, medical device, pharmaceutical, transport, packaging, industrial, and consumer products. By integrating science, technology and business expertise, Smithers’ goal is to add value throughout the lifecycle of our clients’ products. Please visit www.smithersrapra.com.
About The Smithers Group:
Headquartered in Akron, Ohio, The Smithers Group includes Smithers Apex, Smithers Avanza, Smithers Pira, Smithers Quality Assessments, Smithers Rapra, and Smithers Viscient. Each Smithers Group company provides technology-based services focused on a defined market. As a group, the diversity of market sectors and technologies provides stability and a platform for long-term growth. By integrating science, technology and business expertise, Smithers’ adds value throughout the lifecycle of our clients’ products, by utilizing testing, consulting, information, and compliance services. All Smithers companies are known by their clients as Trusted Providers of Innovative Solutions. For more information, visit www.smithers.com.
You can reach the Smithers Rapra North America office at:
425 West Market Street
Akron, Ohio 44303