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Some conditions are sure to trigger an inspection: the launch of a new product, a significant number of adverse reactions among patients, or a previous manufacturing violation Altogether, agency officials annually make over 20,000 inspections of food and drug facilities It s like having a policeman show up at your door, explained one quality operations manager at a manufacturing plant of a major US pharmaceutical company, whose job includes making sure that products meet all the specifications and serving as the liaison to the FDA Your assumption is you haven t done anything for them to inspect, but The manager s voice trailed off (The manager wanted to remain anonymous because the pharmaceutical company, like most of its peers, is very touchy about having employees quoted) About four FDA inspectors will probably show up for the inspection, staying anywhere from one day to three weeks.

Since they think that everything they don t understand is risky, and since they don t really want to understand anything new, you can often nd deals where you can get paid as though you took a lot of risk, and all you really did was your homework! What a deal I get paid for making a highly risky bet, when all I did was read the ne print and pick out the bet that wasn t really that risky That s what the bond market has been for me, and it can be the same for you..

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They will tour the plant and also pore through the records, asking technical questions: What chemicals are used in the quality tests How are the solutions prepared Why is the procedure done this way They may question the line workers and even ask them to demonstrate how a required procedure is followed Schiller is a family-owned company based in the small town of Baar in northern Switzerland that makes cardiac defibrillators and other devices that are sold in the United States With no more than a day s warning, three or four FDA inspectors show up every couple of years at its fourfloor headquarters-and-factory building, perched quietly on a street of two-story, pastel stucco homes, said Alessandro L Z si, the international sales manager Z si seemed very casual about this The inspectors stay no more than four days, they inspect samples and records, and work goes on.

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The people are quite nice They re strict, but they quite clearly know the business of what they re doing, Z si said In its 30-year history, he went on, Schiller has never had a serious problem with an inspection..

Use a 10 -long six-strand of ribbon cable for connections F K (this will go to the right board) and a 12 -long five-strand of ribbon cable for connections A E (this will go to the NES motherboard) Make a black mark on the other end of the A connection wire for later reference As you make these boards, use the following guidelines: Take note of where the pre-drilled holes are on the board they are not symmetrical, and must match the drawing There s a gap three holes wide on the left side, but it s only two holes wide on the right (under the IC) Break off the specific leads shown on the two tact switches All the remaining tact switch leads must be soldered to the board for the circuit to work The flat portion of the 2N4401 transistor should face to the right.