E&L USA pre-conference workshop

An Introduction to Extractables and Leachables Testing

Tuesday May 15: 2.00pm - 5.30pm

Led by: Dr Andrew Feilden, Principal Consultant at Smithers Rapra UK and Sukhy Toot, Product Manager - Medical & Pharmaceutical Services at Smithers Rapra NA

The workshop will provide an introduction to the major concepts and practises associated with extractable and leachable testing. It will allow new entrants to the field a chance to gain an understanding of the discipline and allow them to better understand and appreciate the conference proceedings.

Key points covered will include:

Introduction to extractables and leachables
- Background
- Regulations, who wants what
Material selection
- What affects extractables and leachables
- Risk based analysis
Extractable and leachable testing
- How to carry out the testing
- What limits of detection are required

 

Who should attend?

- Medical device and pharmaceutical product R&D, design, engineering, manufacturing and quality professionals
- Pharmaceutical product packaging and labelling R&D / material-selection professionals
- Manufacturers of components for use in pharmaceutical manufacturing processes.

 

Your workshop leaders:

Dr Andrew Feilden, Principal Consultant at Smithers Rapra

Andrew Feilden joined Smithers Rapra as a Principal Consultant in June 2011. He specialises 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.

 

Sukhy Toot, Product Manager - Medical & Pharmaceutical Services at Smithers Rapra NA

Sukhy Toot is a Chemistry graduate with 15 years of experience within the pharmaceutical industry. These were gained as a research scientist, and through various leadership roles in the development and testing of inhalation products and materials characterization within Sanofi-Aventis; and as a development team leader for orally inhaled and nasal drug products (OINDP's), ophthalmics, and sterile manufacture within Teva. Sukhy has an extensive working knowledge of regulatory requirements acquired while leading the compilation of regulatory dossiers and responses to agency questions around both analytical sections, and container closure system extractables and product leachables.