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