Site director

It is interesting to note that an article in the Buffalo Courier Express dated September 23, 1978 headlined "Study Shows Canal Air Beats L.A." tried to put exposure levels in perspective by comparing data for basement benzene and toluene levels with atmospheric concentrations in Los Angeles, as posted in the office of a Dr. Philip Taylor, then on-site director for the state Health Department. 

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. 

U.S. Army. Undated. Environmental Assessment for Ballistics Testing of Tent and Foam for Use in Removal Actions at Aberdeen Proving Ground, Maryland. Available online at restor/environmental assessment.htm>. Last accessed May 3, 2006. 

Site director. This person must give his wholehearted and visible support to the quality management system (see Section 4.5 for a more detailed discussion). 

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

Let us compare the experience of applying a formal nonconformity (NC) management system on two different process plant construction sites, A and B. On site A, from the day the site was opened, the NC management system was operational, an initiative totally supported by the EPCM contractor s site director, who considered it essential for mastering any quality problems that might arise. 

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. 

If you have one quality system, the roles of management representative and quality director become difficult to separate and can cause a conflict of interest unless the management representative is the CEO. In large organizations with multiple sites, each with separate ISO 9000 registrations, a more appropriate solution is to have a management representative for each site and one quality director for the whole organization. 

I am pleased to announce that the Management Committee has designated (corporate safety director) to lead the development of our companywide PSM initiative. In this capacity, (name) will be responsible for recommending a detailed plan of action for review and approval by the Management Committee. Our expectation is that, once approved, the plan will be tested at a selected site to be determined, and ultimately implemented throughout the company. 

All alkyl groups, not just methyl, are activating substituents and ortho, paia directors. This is because any alkyl group, be it methyl, ethyl, isopropyl, rerr-butyl, or any other, stabilizes a caibocation site to which it is directly attached. When R = alkyl. 

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. 

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