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    Training SOP Part - 3

    Uploaded by

    RainMan75
    The document outlines procedures for training evaluation, certification, ongoing training, documentation, and visitors in a pharmaceutical company. It describes evaluating all training through written or oral assessments. Trainees scoring below 80% must retrain within a week, while those between 80-99% discuss topics with trainers within a day. It also details maintaining training records and matrices to track classroom, on-the-job, and retraining conducted annually or when standard operating procedures change. Finally, it states visitors must be briefed on safety and accompanied by a trained employee.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    Training SOP Part - 3

    Uploaded by

    RainMan75
    95 views4 pages
    The document outlines procedures for training evaluation, certification, ongoing training, documentation, and visitors in a pharmaceutical company. It describes evaluating all training through written or oral assessments. Trainees scoring below 80% must retrain within a week, while those between 80-99% discuss topics with trainers within a day. It also details maintaining training records and matrices to track classroom, on-the-job, and retraining conducted annually or when standard operating procedures change. Finally, it states visitors must be briefed on safety and accompanied by a trained employee.

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    Training SOP Part -3

    Original Title

    Training SOP Part -3

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    The document outlines procedures for training evaluation, certification, ongoing training, documentation, and visitors in a pharmaceutical company. It describes evaluating all training through written or oral assessments. Trainees scoring below 80% must retrain within a week, while those between 80-99% discuss topics with trainers within a day. It also details maintaining training records and matrices to track classroom, on-the-job, and retraining conducted annually or when standard operating procedures change. Finally, it states visitors must be briefed on safety and accompanied by a trained employee.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    95 views4 pages

    Training SOP Part - 3

    Uploaded by

    RainMan75
    The document outlines procedures for training evaluation, certification, ongoing training, documentation, and visitors in a pharmaceutical company. It describes evaluating all training through written or oral assessments. Trainees scoring below 80% must retrain within a week, while those between 80-99% discuss topics with trainers within a day. It also details maintaining training records and matrices to track classroom, on-the-job, and retraining conducted annually or when standard operating procedures change. Finally, it states visitors must be briefed on safety and accompanied by a trained employee.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 4

    Training SOP in Pharma -3

    5.Training evaluation:

     Carry out the training evaluation Of each training session to determine the
    effectiveness of the training programs and understanding of the subject
    covered in the training program. the document is an assessment in “training
    assessment record” as per annexure.
     All the training (on the job training and classroom training) shall be evaluated
    through a written assessment only.
     in exceptional cases where oral feedback for group discussion can be done
    on pre-defined parameters prepared as per annexure “oral feedback /group
    discussion questionnaire” which are to be assessed by the evaluator after the
    oral feedback or group discussion.
     in case of written assessment grade the individual based on a percentage as
    follows: (100% “satisfactory”) and ( 80% 99% “discussion required”)
     The trainer should personally call the trainee and discuss a topic in brief to
    the trainee. so to find out if the trainee has understood the topic properly. In
    such a case oral feedback is satisfactory, the same shall be entered in the
    evaluation sheet.
     Below (80% “not satisfactory”) trainees should be trained within a week.
     in case, the trainer has to discuss the topic with the trainee due to
    performance in the assessment is 80% to 99%, the same shall be done within
    one day from evaluation of the training.
     An evaluator can carry out re-evolution on the basis of the training
    assessment record answer sheet.
     That attendance to be documented as per annexure “training attendance
    sheet”.
     After completion of each training, the individual training index is to be updated
    in the “job-specific training index”.
     During the training period, the person shall be trained in all topics related to
    the department and more specific to the duties to be assigned to the
    individual.
     The trainee should work along with trained personnel and training relevant to
    the task has been satisfactory completed assessed and documented.
     After valuation, the job responsibility Shall be effective and approved by
    Department Head as per SOPs “stabilizing job responsibility”

    6.Certification:

     After completion of initial training, the experienced person shall be issued


    a “training certificate for experienced personal” as per annexure and a new
    recruit shall be issued a training certificate for new recruit as per annexure
    and then the new recruit/experience person shall be permitted to work in his/
    her designated area.
     Original copy of the Training Certificate to be filled in the respective training
    file and one copy to be given to the respective department head.

    7. Ongoing training:

     Prepare a training calendar on an annual basis identifying the training plant in


    each month as per the “training calendar”.
     Conduct training programs individually or in a group so as to include is the
    person working in the department.
     Ensure that each person receives training on various subjects, which include
    training on cGMP, GDP (Good Distribution Practice), Data integrity
    governance at least once annually. this annual training shall be evaluated
    through “written assessment record” or “oral feedback /group discussion
    questioner” whenever applicable as per annexure.
     In case any person is absent for training sessions then conduct the training
    for the absentees within four weeks after he/she resumes duty. annual
    training shall be Reconciled as per annexure “annual training employee
    reconciliation format” and separate training sessions shall be organized
    irrespective of the planner to train all the employees in-plant if required.
     Training shall be completed as per the “training Matrix” indicating
    departmental and cross-departmental standard operating procedures. the
    date of actual completion shall be recorded in the space provided in the
    matrix on completion of training.
    8.Type of training

    8.1 Classroom training:

    Classroom training shall be imparted as per predefine training need


    identification schedule for SOPs, cGMP, system, health, safety, behavioral
    activities and other types of training.

    8.2 On job training:

     on job training such as SOPs training and operational training shall be


    identified based on the activities/functions that to be handled by the personal.
     Training shall be imparted by explaining the basic requirement/Precautionary
    measures to be followed during the activity.
     on-job training in the presence of trained personnel shall view the
    operations/activities for which he will be responsible during his routine activity.
    8.3 Retraining for the training of personnel:

     Conduct retraining within a week’s time in case the individual performance


    and satisfactorily.
     in case of any laboratory error or deviation identified for any individual,
    retraining should be imported to all the laboratory/ department personals.
     All employees shall be given refresher training on a particular subject at least
    once every two years if no change in the SOP for the procedure has occurred
    in that time span.
     in case there is a change in SOP or procedure refresher training shall be
    imparted irrespective of the calendar matrix.

    9. Documentation for the training of personnel:

     Maintain the record of each training session and is its evaluation conducted
    for each training in the individual training file. maintain the record of training
    attendance sheet in general training file.
     The general training file consists of a training attendance sheet.
     The individual training file concept of induction schedule job-specific training
    need identification form (for new recruit),job-specific training index, training
    assessment sheet, training record, Training Certificate, and trainer
    qualification certificate as applicable.
     Maintain the training Matrix in the respective department and older version to
    be submitted to the Quality Assurance department for archival on an annual
    basis.

    10 visitors or untrained personnel:

     As far as possible avoid taking a visitor or untrained personal into production


    and quality control area, in case it is unavoidable brief them in advance about
    personal hygiene, gowning system, entry/ exit procedure, and safety
    requirement. A site trained personal shall always accompany this personal.
    Abbreviations:
     Dept – Department
     QA – Quality assurance
     QC – Quality Control
     % – Percent
     SOP – Standard operating procedure
     cGMP – Current good manufacturing practice
     P&A – Personnel and Administration

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