As the use of rubber and plastics in medical devices and pharmaceutical packagingchanges with the growing life science industry, it’s becoming increasingly crucial to understand the importance of extractables and leachables (E&L). With a focus on patient safety, Smithers Rapra’s upcoming training course on Oct. 17 & 18 will provide valuable knowledge on E&L regulatory requirements, the keys to a successful E&L study, and the role of E&L studies in patient safety and the integrity of pharmaceutical products.
Topics will include:
- Definitions of extractables and leachables and why they are important
- Overview of available sources for guidance on E&L including specific documents and industry groups
- Overview of the multitude of factors involved in E&L study design
- Get regulatory guidance and training from industry experts
- Overview of sample preparation and the analytical methodologies employed in extractables studies
- Detailed summary of leachables including method development and validation considerations, setting limits, and on-going screening
- Review of case studies with specific examples demonstrating potential sources of extractables and leachables and the impact on the drug product
Sessions will be led by Smithers’ top E&L experts:
- Dr. Dan Norwood, Senior Independent Consultant: Dr. Norwood is a pioneer in the development of extractables and leachables science. He is a Distinguished Research Fellow in Analytical Development for Boehringer Ingelheim Phamraceuticals, Inc. Learn more >
- Paul Cummings, General Manager, Smithers Rapra Analytical Services Lab: Paul is responsible for Smithers’ new E&L lab located in Akron, OH. He has extensive experience in extractables and leachables and other areas of packaging testing such as container closure integrity.
- Dr. Andrew Feilden, Chemistry Operations Director: Dr. Feilden has over 16 years of experience supporting the pharmaceutical industry and oversees extractables and leachables studies at Smithers Rapra’s E&L lab in the United Kingdom.
- Alison Schweda, Principal Scientist: Alison is primarily responsible for process implementation, execution and conduct of projects and studies, sample preparation, extraction, analysis, and result reporting at the migration chemistry lab located in Akron, Ohio.
For a complete schedule and a comprehensive outline of the curriculum, click here.
The training costs $1,099, which includes course materials and meals. The training will take place at Cuyahoga Community College’s Hospitality Management Center in Cleveland, Ohio. Use the discount code RAPRAEL to receive 10% off your registration.