Planning defined

Wlien the appropriate researeh has been eompleted, it is time to use the information to develop the site-speeifie safety plan. Keep in mind that this plan will provide the basis for proteetion of workers, visitors, and the publie. The plan defines health and safety hazards, eontrols, and requirements for individual aetivities at a speeifie worksite and provides doeumentation to help identify and eontrol health and safety hazards before fieldwork begins [1],... 

Selecting and developing an incident investigation plan defining the scope of the investigation... 

The quality plan defines the inputs and outputs of any laboratory process. For example, the quality plans refer to the analytical methods, the irrstnrments and laboratory equipment that are used for the analysis, the characteristics of the analysis results etc. All laboratory processes (e g. analytical methods) and laboratory products (e g. analytical resrrlts) should be subject to verification and validation to ensme that they are fit for the ptrrpose. The acceptance criteria should be defined and records should always be kept as evidence of meeting the requirements. 

Study means an experiment or set of experiments in which a test item is examined. The study plan defines the objectives and experimental design of the study. 

The next section of the business plan defines the critical risks and opportunities of the business. Here, the plan should outline the major strengths and weakness of the proposed business and describe the opportunities and risk associated with the program if implemented (as formulated in the SWOT analysis). This information, both positive and negative, must be presented in an unbiased manner so that an informed decision can be made about moving forward with the program. 

There is no clearcut dividing line between phase 2 and 3. (The latter usually includes well-controlled clinical trials of the type performed during phase 2, but in larger populations, under less-controlled conditions.) The sponsor of an IND should carefully determine the time when late phase 2 has been clearly passed (efficacy has been essentially demonstrated statistically to a sufficient degree of confidence) and the drug is ready for phase 3 development. At this point, with phase 3 plans defined, a meeting with FDA is appropriate. 

Business Continuity Plans define how significant unplanned disruption to business operations (sometimes referred to as disasters) can be managed to enable the system recovery and business to resume. Disruptions may occur as a result of loss of data or outage of all or part of the computer system s functionality. The range of circumstances causing disruption can range from accidental deletion of a single data file to the loss of an entire data center from, for instance, fire. 

Determining and documenting how a PEC-based system is going to be validated, in the form of a Validation Plan, is an integral element of the validation life cycle. A Validation Plan defines the strategy for establishing an appropriate level of documentation to demonstrate that a PLC-based system functions in a manner consistent with its specification and does not in any way impair product safety, quality, and efficacy. A Validation Plan should be produced for all validation projects. The components of a Validation Plan should include the following ... 

Contingency Planning defines the plans and procedures that are required to ensure that system failure (hardware or software) can be recovered with minimal (quantifiable) impact on the validated state and without risk to safety, the environment, or product quality. Automation strategies incur the penalty that most, if not all, the eggs are in one basket. ... 

Validation Master Plan A high-level plan coordinating a number of validation plans. [Defined for this book.]... 

Written in advance, the test plan defines all test procedures with their pass/fail criteria, expected test results, test tasks, test environment for equipment and computers, criteria for acceptance and release to manufacturing, and the persons responsible for conducting these tests. The test plan also specifies those functions excluded from testing, if any. Individual tasks cover functional testing, simulation of incomplete functions as integration proceeds, mathematical proof of results, records of discrepancies, classification of defects and corrective actions. 

The Sixth International Conference on Harmonisation will take place in Japan in the last quarter of 2003. In the meantime, the next ICH Steering Committee meeting was held in Tokyo, Japan, in May 2001. The priority before that was continuing work on the implementation of the CTD along with the principles and work plan defined by the ICH Steering Committee . 

Most contingency plans define the structure of the response organization so that roles and command sequences are fully understood before any incident occurs. The On-Scene Commander (OSC) is the head of the response effort and should be experienced in oil spill response operations. The OSC is responsible for making all major decisions on actions taken. This person ensures that the various aspects of the operation are coordinated and sequenced and that a good communications system is in place. 

MONEY-PURCHASE PLANS. Defined-contiibution pension plans include a variant in which the employer promises annually to contribute a certain percentage of salary to each employee s account. These plans, known as money-purchase plans, allow the employer to avoid taxes on as much as 25% of the recipient s salary. In this sense they are comparable to 401k plans. Money-purchase plans, imlike profit-sharing plans, forbid employees to withdraw funds before retirement. 

I approve the Management of Organizational Change plan defined below (or attached in lieu of). All action items have been assigned and are being tracked within a management system to ensure completion. 

Production Program Planning The rolling and periodical production program planning determines the type, quantity, and time of products to be produced and is defined by production and sales representatives. The result is a production plan which is adjusted with regard to marketability and feasibility. The production plan defines the point of time and quantities in which products... 

A) The terms employee pension benefit plan , defined benefit plan , defined contribution plan , and normal retirement age have the meanings provided such terms in section 1002 of this title [section 3 of the Employee Retirement Income Security Act of1974]. 

Parts handling plan The handling plan defines how parts will move between operations in the process internal to the supplier plant. 

Based on a multi step approach a master process plan defines tasks for all involved disciplines in the development process. The individual targets that have to be fulfilled are defined. Each step will be finalized by a quality gate, where all partners have to report the current status which is requested at this point in time. To simplify this reporting a status report based on traffic lights is often used. 

SIS validation planning defines all activities required for validation include the following items - 15.2.1 a. 

Action plans can serve as a road map to move your safety program from where it is now to where it should be. An action plan defines what steps should be taken and the order in which tasks should be performed, and it identifies who is responsible for completing each task [5]. The plan must be specific and flexible enough to respond to change as the management systems and program grow and develop [5]. 

Low (2) Most options including strategic options for planning defined Medium to high corporate and process level to address risk Response implemented objective achieved, except extremes Emergency/contingency in place and some rehearsed... 

Dutyholders should adopt and implement audit plans defining ... 

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