Training session: An Introduction to E&L

At this September's much anticipated Extractables and Leachables China, experts from Smithers Rapra will provide an interactive training session on 'An Introduction to E&L'.

The session, taking place before the main conference on Tuesday 11 September, will provide attendees with in-depth training and insights on the major concepts and practices associated with extractables and leachables testing. 

Topics that will be discussed include:

  • Introduction to extractables and Leachables
    • Definitions
    • Chemical entities (chemical diversity)
    • Sources
  • Regulatory environment
    • Regulatory guidances
    • Best practices
    • Standards
  • Threshold Concept
    • Safety based thresholds
    • Analytical threshold (AET)
  • Extractables assessment
    • Basic principles
    • Generating the extract
      • extracting solvents
      • extraction techniques and conditions
    • Characterizing the extract
      • identification of extractables
      • quantitation of extractables
  • Leachables assessment
  • Simulation studies
  • Extractable elements

Designed for new entrants and those seeking a knowledge refresh, the training will allow attendees to gain a deeper understanding of the discipline, whilst also enabling them to speak directly to industry experts.

Access to the training morning is included in all conference tickets, so you'll gain additional learnings at no extra cost! 

BOOK YOUR TICKET NOW >

Meet your workshop leaders:

  • Dr. Andrew Feilden

    Chemistry Operations Director Smithers Rapra

    Andrew Feilden joined Smithers Rapra as a Principal Consultant in June 2011 and was appointed Chemistry Operations Director in October 2012. He specializes in extractable and leachable testing and the selection and assessment of materials for medical and pharmaceutical applications. Andrew previously worked at AstraZeneca for 12 years, leading their extractable and leachable testing. He has been working in the field of trace analysis using hyphenated techniques such as GC-MS and LC-MS for over 12 years. Whilst at AstraZeneca he was an active member of industry working groups, the IPAC-RS container closure group and he was the co-chair of ELSIE material group. Andrew gained a degree and D.Phil from York University.

  • Dr. Daniel Norwood

    Executive Partner SCIO Analytical & Senior Consultant at Smithers Rapra

    Dr. Daniel Norwood joined SCIO Analytical as Executive Partner in June 2015. Prior to SCIO Analytical, Dr. Norwood was a key technical employee at Boehringer Ingelheim Pharmaceuticals where he was successful in various pharmaceutical development roles, including Director Physical and Chemical Analysis.  In June 2015, Dr. Norwood retired with the title of Distinguished Research Fellow in Analytical Development.  Prior to joining Boehringer Ingelheim, Dr. Norwood, with Dr. Feinberg, founded the Structural Chemistry Group at Magellan Laboratories, later Catalent Pharma Solutions, which became widely recognized for its work in pharmaceutical impurity structure elucidation, and in leachables and extractables characterization. Prior to Magellan, he was a pharmaceutical development scientist at the Glaxo Research Institute.  

    Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing.  He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.