Examples of recent FDA excipient inspection findings and actions,
describe FDA’s definition of excipients as “drug components” and review
drug product/component adulteration provisions of the Food, Drug &
Cosmetic Act. In addition, regulatory requirements for handling
non-conformances, FDA’s expectations for investigations, and
best-practice strategies (with examples and poll questions) for
addressing corrective and preventative actions (CAPA) will be covered.
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