Home 2011 Health or Medical Residual Solvents: Practical Strategies for Compliance

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Residual Solvents: Practical Strategies for Compliance

Residual Solvents: Practical Strategies for Compliance

Venue Name: Online Event
Country: United States of America
City: Palo Alto
State: CA
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Compliance Training, Web Event,Web Conferencing,Web Seminar, E-learning,FDA,
Start Date of Conference:: 04-12-2011
End Date of Conference: 04-12-2011
Description of Conference: 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.

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