Third party examples

Several publishers have opted to develop proprietary programs rather than purchase services from a third party. Examples include the American Chemical Society1 s ACS Paragon System and the American Institute of Physics Peer X-Press. These packages offer features and workflow similar to those contained in commercial editorial packages. 

Have allegations been made by a regulatory agency or third party that releases of hazardous materials from the facility (for example, the facility releases contaminants to nearby wells) harmed or threatened to harm persons, property or the environment If yes, explain. 

Kerridge has provided an excellent article on the interface betw een the operating company and the contractor to define all requirements in complete and standardized detail. This includes who is responsible for every deliverable. The operating company and contractor must work as a team. An example of one area that needs to be reviewed often with the contractor is the provision of secondary systems as packages, perhaps from a third party. Such systems can easily become orphans. This problem is discussed in the Process Definition section of Chapter 16. 

There is no requirement for you to state the policies to meet each clause of the standard but many organizations in fact do just this. ISO 9001 requires the manual to cover the requirements of the standard and ISO 10013 gives an example of how this may be done. ISO 10013, however, points you in the direction of producing a quality manual which is structured in the sequence of the key elements of the standard rather than the operations of your business. This is fine for third party auditors but not for your staff, who will probably want to know your policy on some aspect of your operations in order to make a certain decision. This is where you need operational quality policies organized around the operations of the business - such an approach is deemed acceptable in ISO 10013. 

Other s negative emotions. In cases where a third party feels compromised by any one mentoring relationship, mentor and/or mentee can be put at a disadvantage. For example, if the mentee becomes the subject of someone s envy (most likely an individual who was unable to enter a mentoring relationship), the scene could be set for some unpleasant events. These may include active attempts by this third party to harm the mentee s reputation and obstruct his or her progress. 

Keeping interference with the relationship by third parties to an absolute minimum - for example, although line managers should be involved in the association, they do not have to receive a report every week. 

A particular variant on the bistatic and multistatic themes is Passive Coherent Location (PCL). This is normally taken to mean a system where transmissions are provided by a third party and only the receiver is formerly part of the design. This is sometimes also referred to as a hitch hiking mode of operation. It is also usually referred to as an example of bistatic radar although, as we shall see later, many transmissions can be used from a variety of transmitter sites thus making an example of multistatic radar. 

For example, a library management system deals with loans, reservations, and stock control. A third-party component is bought to deal with membership. This is a conventionally written component (probably built atop a standard database) with an API that allows members to be added, looked up, updated, and deleted. 

Notice that one actor s view of the component often includes some understanding of the component s effect on third parties, if the actor has some means of access to them outside the system. For example, suppose I press some buttons on my phone, and then say "come to dinner at 8pm" to it I do not expect the phone to appear at the table in the evening nor do I imagine that my only access to my invitees is by shovelling the food down the wire. Instead, I understand that what I do to the phone has an effect on people with whom I have other means of interaction. 

For any new excipients, APIs or drug products (where new does not necessarily mean novel, but new to the receiving site) there are additional testing criteria, e.g. supplier audits, third-party contract laboratory audits, analytical method transfers, sample management/tracking, etc. For those key excipients, where there is on-site historical experience, it still behoves both parties to check whether the local grade/supplier used by the CMO is equivalent to that used by the supplier (Worsham, 2010). There are many examples of differences in excipient physical properties, e.g. particle size, which have been attributed to different excipient sources that could ultimately impact on the performance of those excipients in formulated products (Frattini and Simioni, 1984 Dansereau and Peck, 1987 Phadke et al., 1994 Lin and Peck, 1994). 

In practice, the Patriot Act and its successors, has circumvented the check and balance system. The Executive Branch has, for example, lowered the threshold of probable cause to the level of suspicion it has equated criminal activity with terrorist activity it has removed or delayed notice requirements for warrants it has required mandatory compliance on third parties for the production of information gathered secredy it has imposed a gag order upon notice and production of information it permits sharing of confidential personal information between investigative units and minimized the role of the judiciary. The overall effect is the Executive Branch and Justice Department are assuming power to define application of the Fourth Amendment. An additional result is the collection of a wide variety of highly personal and sensitive information on law-abiding individuals. 

Payment by third-party payers, especially by the national health insurance programs or social security funds, has expanded dramatically during the last several years and the program to promote rational use of drugs is soon expected to make significant contributions. A good example is a program such as... 

Chemical reactions enhanced by catalysts or enzymes are an integral part of the manufacturing processes for the majority of chemical products. The total market for catalysts and enzymes amounts to 11.5 billion (2005), of which catalysts account for about 80%. It consists of four main applications environment (e.g., automotive catalysts), 31% polymers (e.g., polyethylene and polypropylene), 24% petroleum processing (e.g., cracking and reforming), 23% and chemicals, 22%. Within the latter, particularly the catalysts and enzymes for chiral synthesis are noteworthy. Within catalysts, BINAPs [i.e., derivatives of 2,2 -bis(diphenylphosphino) -1, l -bis-l,l -binaphthyl) have made a great foray into chiral synthesis. Within enzymes, apart from bread-and-butter products, like lipases, nitrilases, acylases, lactamases, and esterases, there are products tailored for specific processes. These specialty enzymes improve the volumetric productivity 100-fold and more. Fine-chemical companies, which have an important captive use of enzymes, are offering them to third parties. Two examples are described here ... 

The validity of a granted patent may be challenged by a third party throughout the life of the patent on the grounds that it does not satisfy certain statutory requirements (for example, that it is not new or that it is obvious). Typically, the challenge may take place before the relevant patent office or before the national courts. 

The edternative to a one-to-one confrontation is to involve the whole group or team, as is exemplified by the case history in Box 7.3. This example has been chosen, partly because I have first hand knowledge of the episode, but more particularly because it was handled by an internal manager rather than by an external third party. Not only does It illustrate well the simplicity of the principles involved, it also shows that this sort of intervention can be done perfectly competently by an ordinary manager. Although the procedure is simple, the emotional stress involved in undertaking such a confrontation, and the self-confidence required too, should not be underestimated. 

In trading grain, for example, if exported wheat is analyzed by both buyer and seller for protein content, they should be confident that they will obtain comparable measurement results in other words, results for the same sample of wheat should agree within the stated measurement uncertainties. If the results do not agree, then one party or the other will be disadvantaged, the samples will have to be remeasured, perhaps by a third-party referee, at cost of time and money. Different results could arise from genuine differences in the value of the quantity for example, the wheat could have taken up moisture or been infected with fungus, so it is important that the analysis does not lead to incorrect inferences. 

The international search report is communicated to the applicant by the international search authority. The applicant may then decide to withdraw his patent application if, for example, the prior art found makes the granting of a patent highly unlikely. If the international patent application is not withdrawn, it is published together with the search report. Third parties now have the possibility to take notice of the claimed invention and to form their own opinion about its presumed patentability. In addition, they can assess any possible later dependencies should they want to practice the invention. An example of the cover of a published international patent application is shown in Figure 13.2. 

The technical and economic constraints and the legal environment affect the choice of the contractual framework for gas deliveries via pipeline. For example, depending on the number of suppliers and clients, and the regulations governing the construction and operation of a gas pipeline, the role of the pipeline can be that of a gas merchant, a hybrid pipeline or a gas transporter. A merchant pipeline typically buys all the gas at the inlet point, transports it and re-sells it at outlets to different clients it does not provide third party access, unless specifically required to do so by law. In the latter case, it becomes a hybrid pipeline. A hybrid pipeline would engage in both gas sale and purchase and gas transportation activities, as well as in any of the associated services. Hybrid pipelines are a particularly difficult case to regulate and to ensure competitiveness and non-... 

Process flowcharts. A flow diagram should indicate the process steps and addition of raw materials. If possible, major equipment and special environmental conditions may be included in the flowchart. In-process tests may also be included. A second flowchart for activities, raw material suppliers, shipments, and testing would also assist in the overall picture of the aerosol manufacturing scheme, especially for multiple site or third-party activities. An example of a process flowchart for a fictitious suspension product (2160.4-kg batch size for 100,000 units) is shown in Figure 6. 

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