Live eLearning - PDA 613.1 Biopharmaceutical Impurities: Impact on Macromolecular Stability and Patient Safety
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Individual Registration
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This training course is designed to instruct the attendees in:
- The sources and identification of impurities in Biopharmaceuticals
- The regulatory guidelines for monitoring impurities in the Biopharmaceutical Industry
- Potential impacts of impurities on patient safety
- Potential impacts of impurities on the active pharmaceutical ingredient (primarily large molecules/proteins)
- Methods for monitoring the effect of impurities on macromolecular stability
- Communicate the sources and chemical identification of the most common impurities found in biopharmaceutical products
- Define what regulatory guidelines are in place that govern the investigation and identification of biopharmaceutical impurities
- Define the regulatory impact of adverse patient safety events, and guidelines for understanding and ensuring patient safety as it relates to impurities present in the packaged drug product
- Review the chemical and thermodynamic nature of biological macromolecules
- Demonstrate how to set up experiments to determine the impact of impurities on the stability of the protein molecule
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Standard Pricing
Standard Member Price
$500GovernmentMember Only
$500
Health AuthorityMember Only
$500
AcademicMember Only
$500
Non-Member
$500
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