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Metal Impurities in Finished Drug Products: Dealing with a Changing and Uncertain Landscape
The ICH is rewriting the rules on metal impurities in manufacturing — with barely any notice. Worried you’ll get caught short? Then please read on ...
Drugmakers received a nasty surprise a few months ago as the ICH proposed new rules regarding metal impurities in finished drug products.
How to prepare for compliance in a changing and uncertain landscape?
Luckily, FDAnews secured a top expert on metal impurities, Nancy Lewen, to explain the new guidance. In 90 information-packed minutes, she helps you understand what’s going on and how to prepare for compliance — starting now. You’ll discover:
The new metal impurity limits are likely to cause upheavals in quality management and in-bound materials testing departments at drugmaking facilities worldwide. Be proactive. Act now to head off regulatory tangles tomorrow.
Nancy Lewen is a specialist in atomic spectroscopy techniques, with more than 25 years’ experience at Bristol Myers Squibb. She is a member of the USP chemical analysis expert committee, and sits on the USP Elemental Impurities Advisory Panel as well as the USP <191> modernization and waters subcommittee. She is a recipient of the BMS Chemistry Leadership Award, and the Outstanding Women in Science Award from the New Jersey Association of Biomedical Research.
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