Temple University 3 credits QARA
This course provides a detailed overview of Pre-Approval Inspections and how to conduct audits of facilities based on the responsibilities delineated in a pending drug application, including NDAs, ANDAs and NADAs. Emphasis is placed on reviewing the Pre-approval audit process, Pre-Approval laboratory issues (including analytical and microbiological), technology transfer, case studies involving various dosage forms, and outsourcing issues. This course stresses key areas for Pre-Approval inspection audits. Case studies help prepare students for issues arising during a Pre-Approval inspection. The history and evolution of the Pre-Approval program are discussed. Note: Not open to students who have taken the former PHARMACEUTICS 490.
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