1.0. PURPOSE:
To lay down guidelines for training of new entrants and periodic retraining of technical staff.
2.0. SCOPE:
To define role/responsibility of various functions responsible for technical training.
3.0. RESPONSIBILITY:
3.1. Corporate Managers
3.2. Departmental Manager(Qualified Trainer
3.1 Overall responsibility to assess the training needs and ensure that training is conducted as per the annual schedule with QA.
3.2 Unit QA Manager shall give cGMP training with help from Corporate QA.
3.3 The Unit QC manager with the help of Corporate manager Quality Control shall give GLP training.
3.4 Unit Production manager shall give technical training for the staff and the operators of Production department with the help of President- Technical.
3.5 Workmen training for both technical and basic rules of GMP shall be done in 'vernacular' language by respective supervisory staff on periodic basis.
3.6 Training should be conducted by a qualified trainer.
3.7 Corporate Managers will train the Unit departmental managers and subsequently will assess them through questionnaires and practical demonstrations.
3.8 The Corporate Managers will approve the departmental managers as “Qualified Trainer” based on the assessment.
3.9. Guidelines
3.9.1. NEW ENTRANTS :
3.9.1.1. New entrants to the organisation shall be given induction training and a brief cGMP/GLP training by Manager QA within 10 days of joining.
3.9.1.2. New entrants should be given technical training (need based) by the departmental manager depending upon the nature of job for one month.
3.9.1.3. New entrant should be instructed to observe the activity in the recruited department for one month after the initial induction program.
3.9.1.4. A written feedback is collected from new entrants after the training to ascertain his/her competence in both technical and cGMP skills.
3.9.1.5. QA Manager shall prepare a regular annual schedule for training/retraining of technical staff.
3.9.1.6. The Qualified trainer who has conducted the training should review and assess the feedback.
3.9.1.7. Based on the assessment, trainer shall identify training retraining needs .
3.9.1.8. Individual Training record should be maintained for each new entrant along with their feedback.
3.9.2. REGULAR TRAINING :
3.9.2.1. Based on the need/requirement, a schedule along with a module should be prepared for the staff and accordingly training session should be conducted.
3.9.2.2. A training session by the Unit departmental manager should be conducted for the following.
i. If any critical changes are made in the Standard Operating Procedure, training has to be conducted to the concerned departmental personnel
ii. If any new equipment is installed, the staff and the operator has to be trained on the operation, cleaning, Maintenance and trouble shooting for the equipment.
iii. If any new product is introduced, the nature of the product, manufacturing, handling and if any critical parameters to be maintained should be explained to production, Quality Assurance, Engineering and Quality Control personnel.
Analytical method will be explained to the Quality Control personnel by the manager
3.9.2.3. For each of the above training session, the Quality Assurance personnel should issue a prior circular to the concerned department to intimate the details of topic, date, time and venue.
3.9.2.4.List of participants with their signatures should be documented during the training session by the Quality Assurance department.
3.9.2.5. The trainer should prepare a questionnaire based on topics covered and issue it to the participants.
3.9.2.6. The participants should write their answers and submit it to the trainer.
3.9.2.7. The trainer should assess the participants based on their feedback.
3.9.2.8. Based on the trainer’s assessment, retraining requirement should be identified by the trainer.
3.9.2.9. The Quality Assurance personnel should file participants feed back in their respective training record.
3.9.2.10. For any minor changes in SOP or process, the Qualified Trainer should give training at the work place and the same should be documented.
3.9.3. TRAINING SHCEDULE:
3.9.3.1. New entrant
General factory rules and cGMP –10days
Technical training – one month
3.9.3.2. Regular training for staff and operators
cGMP – Once in 6 months
GLP - Once in 6 months
Technical training – Once in 3 months
3.9.3.3. A training session by an External Agency shall be conducted as and need/opportunity arises.
3.9.3.4. Apart from the schedule, training/retraining sessions will be conducted as and when need arises.
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