Fair Warning

There would appear to be an appreciation amongst regulators that computer systems are extensively used throughout the drug manufacturing, packaging and distribution process. The computer systems covered by the inspections included MRP II, LIMS, spreadsheets, process control systems and network applications. Between these inspections, a large number of non-compliance observations were made and are summarized below. This summary is based on several hundred noncompliance observations made between the inspections. 

Validation records version of software to be recorded on documents 

Preventative and emergency maintenance logs records required 

Disaster recovery plans exist and have been tested 

Training records exist and are up to date, include contractors 

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Where these observations did not directly result in an FDA 483 citation for noncompliance, they were positioned as fair warning of what the inspectors thought were reasonable expectations and that would be inspected as outright requirements in the near future. 

Here we provide another actual midterm examination from the intense Summer P. Chem. course at VCU in 2008. If students are told they are responsible for derivations like the van der Waals critical point and the Camot cycle they will have a chance to learn them, but it is unlikely students will learn such derivations without fair warning. Since students can learn massive amounts of encyclopedic information in organic chemistry and biochemistry, there is no reason not to expect them to learn key multistep derivations. Learning these key derivations improves the level of the math skill in the class. 

One correct piece of advice though is not to try and increase the current limit of the switcher (that s an easy fix to the D > 0.5 problem—remove the offending current limit circuit altogether). The switch is clearly not rated for such high currents, nor has the company obviously evaluated the reliability under such conditions. So that warning is certainly fair and due. What s wrong is all the rest ... 

Relapse does not just suddenly happen without warning or without reason. Research into the processes of relapse has identified a rather predictable chain of events that lead up to it (see Figure 7.1). Moreover, the fact that a client slips into old behavior once does not mean all is lost. On the contrary, a slip offers a tremendous opportunity for both client and therapist or counselor to improve upon the recovery plan. A slip identifies a weakness in the recovery plan and offers an indication of how to improve it. Remembering the transtheoretical stages of change model (see Chapter 3), a relapse is viewed as part of the change cycle and as a fairly common occurrence when a person learns how to overcome a drug problem. So there is no need to panic if a relapse occurs. 

It is fair to say that dialogue needs to continue between the Agency and the pharmaceutical industry regarding the terminology that the requirement of ALL contraindications, warnings, precautions and side-effects will mandate and its usefulness in informing patients. The question of roll-up warnings remains a subject for discussion, as does a debate about the difference between adverse events and adverse reactions. 

The prediction of such a curve for a specific system has defied mathematical analysis, except in the region of low inertial effects. Recourse must be made to the time-honored method of graphical empirical correlation. Klee and Treybal (K3) arrived at two equations, one for the region below the peak diameter and one for that above the peak. They warn that these are simply good approximations, and that their dimensionless-group equations describe their data and those of other authors fairly accurately. The field liquid in all systems used was one of low viscosity. 

Racially, white patients account for 61% of all drug-related hospital visits in the United States, followed by black (26%) and Hispanics (11%). With the exception of rohypnol, the 69-80% of all club drug incidents recorded by Drug Abuse Warning Network (DAWN) involve white, non-Hispanic patients—a fairly typical reflection of the U.S. population. A far larger share (56%) of rohypnol mentions are attributed to Hispanic patients, but this may have to do with the small sample size available to researchers. 

Previous work with Oldershaw columns (209-211), however, spells a note of caution to Fair et al. s conclusion. For a fixed system, higher Oldershaw column efficiencies were measured under cellular foam conditions than under froth conditions. For this reason, Gerster (212) warned that when cellular foam can form, scaleup from an Oldershaw column may be dangerous. The conclusions presented by Fair et al. (208) do not extend to Oldershaw columns operating in the Cellular foam regime. Other considerations for scaleup from pilot columns (above) may also be important. The scaleup procedure recommended by Fair et al. (208) is... 

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