The FDA Training Module is a must for any organisation which is supplying regulated healthcare products to the US market or to clients who in turn ship to the US. The course provides a grounding on the FDA and the laws it enforces. Every organisation’s management team should be at least knowledgeable of the requirements that pertain to their area of responsibility and authority. Course Contents: Introduction & Class Objective An overview of the FDA (Food & Drug Administration) The FDA’s Quality System Regulation (QSR) – A History GMPs (21 CFR Part 210/211/820/58) - as applicable depending on clients business sector. Inspection Techniques Planning for an Inspection Conducting the Inspection Responding to “483s”Facility Inspection Results. Note: The above syllabus may change during the training course to provide more detail in aspects, which have been ascertained to be of greater value to the trainee. |
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