Methods and Reference Standards for CMC Analytical Studies
About the CPD course
The second course in the online biopharmaceutical and biosimilar CMC analytical series follows on from the first course on regulatory challenges. This course focuses on analytical method lifecycles as well as characterization and control of product reference standards. Learn more about the series here. This course has been designed to provide you with the technical know-how; so you understand and select the right method verification; qualification and validation. During the 4 weeks; you will review the major life cycle elements and deliverables for biopharmaceutical/biosimilar products. In addition; you will learn about the quality; regulatory and monitoring aspects of different types product reference standards and critical assay reagents.
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