The site director

The Validation Master Plan must be reviewed and approved before use. They are regulatory documents demonstrating an organization s intention to validation of one or more computer systems. At a minimum, a Validation Master Plan should be signed and dated by the Site Director/Area Manager, and Site/Area Quahty Assurance Manager, and local Vahdation Manager. 

Note Typically the Host for an inspection is the site QA Manager. It is usually polite for the Site Director to attend opening and closing meetings. 

The site director must be IT competent, enthusiastic and must want to make the system work. 

The organizational chart further identifies key positions in the project team, including the project director, project manager, site safety and health officer (SSHO), site supervisor, emergency response coordinator, site security, and other specialized positions. 

Pesticides used on crops grown on the test site in previous seasons may also have an impact on the outcome of a field residue trial. Carryover of prior pesticide applications could contaminate samples in a new trial, complicate the growth of the crop in a trial, or cause interference with procedures in the analytical laboratory. For this reason, an accurate history of what has transpired at the potential test site must be obtained before the trial is actually installed. The protocol should identify any chemicals of concern. If questions arise when the history is obtained, they should be reviewed with the Study Director prior to proceeding with the test site. In most annual crop trials, this will not be a significant issue owing to crop rotations in the normal production practices, because the use of short residual pesticides and different chemical classes is often required for each respective crop in the rotation. However, in many perennial crops (tree, vines, alfalfa, etc.) and monoculture row crops (cotton, sugarcane, etc.), the crop pesticide history will play a significant role in trial site selection. 

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

Include a disclaimer or deviation in the Study Director GLP compliance statement. The disclaimer route can be used for a phase of a multi-site study but should generally not be used if the work in question is a critical phase, e.g., application. The remainder of the study must be conducted in accordance with the principles of GLP. This route may not be acceptable to overseas regulators and should be avoided if possible. 

The Study Director/Principal Investigator should ideally discuss all multi-site studies with QA personnel prior to study initiation (or prior to the issue of the protocol amendment if work is not detailed in the protocol). When acting as Study Director, a copy of the current GLP certificates should be requested from sub-contracted facilities and should be retained in QA. 

Applications to and harvest of major crops such as coffee, bananas, and pineapples frequently involve procedures and equipment for which standard operating procedures have not been written. These must be identified in the planning stage, so that the Study Director or Principal Investigator can write these procedures with sufficient time to allow for review and approval. If a procedure is specific to the trial at hand, the process may be described in an addition or amendment to the protocol, but this still requires QA and management approval. In some cases, SOPs specific to a local crop are maintained at a regional site. SOPs must also be available at the site at which the raw data are archived. 

When study data need to be transferred to the Study Director at regular intervals (typically after each application, sampling, and shipment), the e-mail and attachment transfer rate is critical. In isolated field sites, with poor telephone tine quality, the upload can take hours. This is also a problem when downloading software updates. Also, the upload/download time may be a problem when it ties up the only telephone tine or fax tine. If available in the area, the use of a faster form, such as cable modem or digital subscriber line (DSL), is preferable. Since telephone tine quality is a common problem, it would be best if software developers sent updates on CD-ROMs. 

Also available at the Enterprise Directorate General s internet site at http //dg3.eudra.org. 

This was a strange ignorance. A month before the Goering order, Schneider had furnished for the site the overseeing engineer named Walter Duerrfeld. Strange ignorance in the director who was also responsible for the welfare of all Farben employees ... 

When the laboratory uses different methodologies or instruments, or performs testing at multiple testing sites, a system is to be in place that evaluates and verifies the comparability between these test results. For example, correlation studies must ensure that manual and automated methods of immunostaining within a laboratory are in agreement. This must be documented biannually. In addition, any reference laboratories utilized must be CLIA-88-certified, and the lab director must monitor the quality of test results received from these outside sources. A mechanism must be in place to evaluate immunohistochemical results that are inconsistent with clinicopathologic studies. This evaluation should be performed and recorded by a laboratory physician. 

Study director means the individual responsible for the overall conduct of the study. Principle investigator means the individual who acts on behalf of the study director in case of multi site studies. Master schedule means a compilation of information to assist in the assessment of the workload and the tracking of studies at a test facility. 

In 1982 Pains moved again, this time to the site of an old chalkpit in Whiteparish near Salisbury where the Decker family continue to own and promote the business and where Wilf Wells, a former Wells director, spent his remaining years. 

The EPA and FDA audit is a formal process involving advance notice, planning and scheduling (Figure 8.2), and a follow-up report, as well as the actual on-site observations and interviews. The advance notice includes an announcement of what specifically is to be audited. When the auditors arrive, the study director and lab workers are interviewed as a group, in what may be called an "opening conference," and the audit plan is laid out for everyone s full understanding. Included here would be a review of the purpose... 

Following selection and approval of the committee members by the Examinations Institute director, the committee begins work on the lengthy process of writing the examination. Typically, the physical chemistry committee meets at the site of each ACS national meeting until work on the examination is completed. Some of the other examination committees may meet at the Biennial Conference on Chemical Education or the ChemEd conference. At the first committee meeting, the committee will typically discuss and make decisions on several items. The first of these items is which examinations will result at the end of the process. Previous committees have opted to write only a comprehensive examination, or a suite of examinations in thermodynamics, dynamics, and quantum mechanics. A second question is how many questions are needed for each examination, and if the multiple choice format is used, how many responses will be used for each question. For example, the committee writing the 2000 set of examinations chose 40 questions with four responses, while the committee for the 2006 set chose 50 questions with four responses. This decision becomes important because it defines the number of questions that need to be written. 

Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel. 

The equipment is selected on the basis of the type of mission to be conducted and the requirements resulting from the Inspection Mandate , which contains the instructions issued by the Director-General to the inspection team for the conduct of a particular inspection. For an Investigation of Alleged Use (IAU) or a Challenge Inspection (Cl), the complete S A equipment will be taken to the site,... 

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