E&L Masterclass: Monday 23 September 2019

Take part in an E&L Masterclass led by Smithers experts Dr Andrew Feilden and Dr Daniel Norwood ahead of the E&L China 2019 conference.

Taking place on Monday 23 September. the masterclass will provide you with key insights into extractables and leachables, regulatory considerations, assessments and more. 

Provisional Schedule

09:30: Registration and welcome refreshments

Introduction to extractables and Leachables

  • Definition and key terms
  • General regulatory requirements
  • Working groups and guidance documents

11:30 Networking break

Extractable assessments

  • Best practices - general consensus
  • Case studies
  • Advanced topics

Leachables assessments

  • Best practices - general consensus
  • Limits based on safety
  • Safety assessment and qualification

13:00 - 14:00 Networking lunch

Regulatory considerations

  • Drug product requirements
  • Combination products
  • Medical devices ISO 10993
  • Breathing pathways ISO 18562
  • Future regulatory trends

Concluding thoughts

16:00 End of workshop

Tickets to the E&L masterclass are $399 in addition to your two-day conference ticket but places are limited so we advise booking as soon as possible to avoid missing out. 

 

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Your Workshop Leaders

  • Smither

    Dr. Andrew Feilden

    Chemistry Operations Director Smithers

    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

    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.