Short Course Listings
Short Course

Course Information
Course Title: Elemental Impurities in Pharmaceuticals
Categories: 1 - Pharmaceutical Sciences
2 - Quality/Regulatory/Compliance
3 - Spectroscopy
4 - Inductively Coupled Plasma
Instructor(s): Nancy Lewen Course Number: 21
Affiliation: BMS
Course Date: 03/18/2013 - Monday Course Length: 1/2 Day Course
Start Time: 01:00 PM End Time: 05:00 PM
Fee: $260 ($360 after 2/18/13) Textbook Fee:

Course Description
The EMA, ICH, USP and EP have all either implemented or will be implementing new requirements for metals testing in pharmaceuticals. These new requirements will involve significant changes over what has previously done with regard to metals testing in pharmaceuticals. The course will cover changes in testing requirements for metals in pharmaceuticals, and will also include potential strategies for addressing the new requirements.

Target Audience
Compendial liaisons in pharmaceutical companies. Regulators Analysts in pharmaceutical companies and/or contract laboratories.

Course Outline
Historical Background regarding metals testing in pharmaceuticals. Problems with previous means of testing metals in pharmaceuticals. Various compendial and regulatory changes with regard to metals testing in pharmaceuticals. How to implement new testing requirements. Strategies to address new testing requirements.

Course Instructor's Biography
Nancy Lewen has worked at Bristol-Myers Squibb for 24 years, and has been the supervisor of the Atomic Spectroscopy Laboratory for most of that time. She is the chair of the USP Elemental Impurities Advisory panel, chair of the USP Chapter <191> Modernization panel and is a member of the USP Chemical Analysis Expert Committee. She has written and presented extensively on the application of atomic spectroscopy in pharmaceutical analyses and is the recipient of the Bristol-Myers Squibb Chemistry Leadership Award (2005) and the New Jersey Association of Biomedical Research Outstanding Women in Science Award (2008).