Compliance with compendial standards for residual solvents is required for all drug
products provided in the United States, and similar requirements exist in all the
major markets of the world.
Since every product is unique, and since the
requirements...
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Compliance with compendial standards for residual solvents is required for all drug
products provided in the United States, and similar requirements exist in all the
major markets of the world.
Since every product is unique, and since the
requirements refer to over 50 different solvents, achieving compliance can be very
challenging.
Many, many firms have received incomplete or warning letters from the FDA as a
result of failure to adequately address the reporting of residual solvents.
This course is designed to provide participants with practical strategies for
complying with regulatory requirements for residual solvents while minimizing
resource requirements.
The course will address FDA expectations, understanding the
potential sources of residual solvents in drug products, appropriate analytical
methodology and strategies for characterizing solvents in components and in drug
product.
The course will address reporting levels of residual solvents, and
conclude with an opportunity
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