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level: Section 1 (1.2)

Questions and Answers List

Training

Question	Answer
All employees who are directly and indirectly engaged in the manufacturing activities shall be trained in the particular operations that the employees perform in accordance with the principles of __	Current Good Manufacturing Practice.
Training shall be conducted by qualified individuals. Special attention shall be given to training of personnel working in __	sterile and clean areas or with highly potent, toxic or sensitizing materials.
Training in Current Good Manufacturing Practice shall be on a continuing basis and with adequate frequency to assure that employees remain familiar with the Current Good Manufacturing Practice requirements relevant to their functions. True or False	True
Training in Current Good Manufacturing Practice shall be in accordance with written program approved by the production manager and the quality assurance manager. True or False	True
__ of personnel training in Current Good Manufacturing Practice shall be maintained and the effectiveness of training programs shall be assessed periodically.	Records
After training, the consequential employees’ performance shall be appraised to determine their capability to meet the qualification requirement for the jobs. True or False	True