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rejects in the process. It is amazing to see all of the seemingly redundant checking processes, and to later
learn that each process is necessary. We learn that Genentech takes great pride in assuring that their
product is of the best quality.
12:45- 1:15 Genentechs role with the FDA and other regulatory
agencies
Another presenter shows us a slideshow shown in the many training courses employees must take
to work at Genentech, specifically focusing on regulatory agencies. We learn about the history of the
FDA, and that most legislature for regulatory agencies are a result of tragedy. There are four types of
inspections from the FDA, the cGMP or unannounced, the pre-license, the pre-approval inspection (for
specific products) and the directed inspection, usually due to complaints. Our internship was postponed
two weeks because the FDA arrived for an extensive cGMP inspection, which required all hands on deck.
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