How to Implement Computer-Assisted Drug Registration - A Practical Guide for Drug Regulatory Authorities - Regulatory Support Series No. 002
(1998; 74 pages)
Índice de contenido
Ver el documentoACKNOWLEDGEMENTS
Abrir esta carpeta y ver su contenidoI. INTRODUCTION
Abrir esta carpeta y ver su contenidoII. PRE-REQUISITES FOR COMPUTER-ASSISTED DRUG REGISTRATION
Abrir esta carpeta y ver su contenidoIII. PREPARING FOR COMPUTER-ASSISTED DRUG REGISTRATION
Cerrar esta carpetaIV. COMPUTERIZING DRUG REGISTRATION
Ver el documentoA. Data to Be Computerized
Ver el documentoB. Preparing Data
Ver el documentoC. Options for Entering Data into the System
Ver el documentoD. Using the Computer in the Drug Registration Process
Ver el documentoE. Train Staff
Ver el documentoF. Ensure Computer System Support
Abrir esta carpeta y ver su contenidoV. MAINTAINING A COMPUTER-ASSISTED DRUG REGISTRATION SYSTEM
Abrir esta carpeta y ver su contenidoANNEXES
 

E. Train Staff

Whatever software system is selected for use at a DRA, staff will need to be trained in how to operate it. In addition, if a network is newly installed, all staff will also need to be trained in how to use it effectively. Provisions must be made for adequate training of all necessary staff members when the new software is installed, and for training any staff member hired after the initial training. It would be best for this training to be done professionally by the technical support team of the software programme, and geared toward making two or more DRA staff members internal experts on the programme. At least one week should be dedicated to training and practice with the new system, preferably without any outside distraction or interruption. All staff members who will be using the computer system should be required to attend training on the software, done either by the external trainers, or by the internal experts.

The training objectives are:

• Ensuring that everyone is aware of the reasons for introducing or changing the computer system and knows what is expected from the new situation

• Ensuring that staff attitudes toward the use of computers are appropriate in view of the new environment

• Creating or improving skills to match the new tasks or the new ways in which usual tasks will be carried out

• Learning how to operate the software system

Assuming that decision makers within the DRA have made the decision to computerize and are therefore already motivated, the first focus of training will be on key staff members whose support is critical in order to motivate the others.

Unless needs are identified for training in specific new procedures that are being introduced concomitantly with computerization, training should be of the hands-on type, using real data and in the usual working environment.

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Última actualización: le 3 mayo 2013