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Pharmaceuticals Guidance

Friday, June 19, 2020

Training Management


Training constitutes a basic concept in human resource development. It is concerned with developing a particular skill to a desired standard by instruction and practice. Training is a highly useful tool that can bring an employee into a position where they can do their job correctly, effectively, and conscientiously.
Training shall be provided to all employees working in their respective areas of each departments as per requirement of job performed and skill matrix. it also cover based on the operation performed by the employees working in different areas.
Departmental Manager shall identify the need of training for different levels. It shall be prepared by training coordinator of concerned department as per need arises.

Selection of trainer:

The HR Manager in consultation with concerned department manager shall identify the internal trainer from different departments based on his / her qualification, communication or presentation skills, experience, knowledge and expertise or combination of these in the different areas of operation. On identification and evaluation as per above criteria, the trainer’s certificate shall be issued to trainer’s, duly signed by Trainers and the training manager.
Trainer list shall be maintained and update as when require and the list of certified trainer shall be circulated to all respective departments.

Type of training :

The types of training are divided into two major categories as Internal Training and External Training as mentioned below.

Internal Training:Internal training is the training, which shall be conducted within the organization by the in house faculty only. It is divided into five main categories as mentioned below:

(1)         Induction Training

(2)         On-Job Training

(3)         Safety training

(4)         Annual Training Program as per annual training calendar

(5)         Advanced Training (as per need)

Induction Training: Induction training is the training which is covering the overview of organization, unit and department, Upon arrival on the first day, the employee shall report to the  human resources     (HR) manager to fill out necessary employment forms. The induction training shall be imparted to every new employee, who joins the organization and shall be co-ordinated by the HR department. The HR department shall prepare an induction-training schedule for every new employee  in consultation with concerned departments,

Induction program shall be conducted as following but not limited to:
  • Organizational Structure
  •  Key personnel and organizational structure of various departments
  • Product range
  • HR policies e.g. duty timing, leave policy and other company and employee benefit policies.
As per the induction-training schedule, the new employee shall go to different section for interaction with the staff members. Head of various departments or designee shall brief to the new employee about their departmental structure, departmental functions and interaction process with different departments.
After completion of  introduction, new employee shall report to the training cell. Training coordinator shall provide brief induction training study material on the below :

(1)               Basic cGMP / cGLP / GEP, /GWP (Through different Modules).

(2)               A brief about Safety Policies.

(3)               Outline instruction for filling Employee Specimen Signature.

(4)               SOP of Training of Personnel.

Note:The candidate reports the all training as Induction training in the training progress card.

After completion of induction training, training coordinator shall hand over the new employee to concerned department manager for the On-Job related training.

On-Job Training:

Based on the qualification, skill and past experience of the employee respective manager of   the concerned department shall assign the job responsibility, training needs job description shall be identified and employee shall be trained accordingly. Training Coordinator shall coordinate the same during the on job training, the task performed by inductee shall be carried out in supervision of a trained staff till the employee is sufficiently trained to perform the task independently. This period may vary from days to months. For all test data generated by a trainee, the supervisor /seniors shall review and approve the data package The Job description shall be effective after successful completion of the on job training.

Safety Training :

Safety training shall be covered at the time of On-Jab training by respective department manager , if require safety team member also provide support about plant, personal safety and work safety.

Annual Training Program :

Annual training calendar shall be prepared by the concerned department, checked by concern department manager and approved by training cell, the skill matrix card shall comprise of topics of training to be covered by the employee. These training programs shall be organized in the concerned department. All related evaluation sheets (Questionnaire) shall be attached with the individual training file and attendance sheet shall be maintained in separate files. Annual training calendar also cover cGMP and quality system related training and same shall be provided by training coordinator, shall be responsible for arranging these training as per calendar.

The mode of training shall be either oral / verbal counseling or through audio / visual presentations prepared as modules, self-reading through printed material (English / Hindi/ vernacular language) & ERP & IT training through remote accessing from the server room.

Effectiveness of training may also be evaluated through verbal question & answer session by the trainer or immediate reporting officer before assigning of work. This shall however, not be preferred much and shall be used in specific case only.
Advance Training:
This training may be provided in the areas, which are new to employees working in the organization example as new SOP which is not listed in the Annual Training Calendar. Any training received for non-routine tasks, tests or expertise under development, expansion of the business, study or research into new areas, shall be classified as Advanced Training. Such trainings may be conducted through classroom training or providing materials for reading or organizing training through external trainer. A copy of the training material and certificates of participation (if received) as a result of this training shall be submitted to the training Coordinator for reference.

External Training:

Quality unit shall liaise with technical services department/regulatory affairs department and shall organize the technical training by vendors/other technical agencies from time-to-time. The selection of external trainer for in house training shall be done with the consent of concerned manager and training manager. The selection of trainer shall be primarily based on his experience, qualification, skills and expertise on the training topics
The external training shall be focused mainly on the technology development, sophistication of instrumentation, other advanced process/validation aspects and other current GMP and regulatory topics. These training shall also be focused on development of persons e.g. Time management, Communication skill, Personality development etc. training record shall be maintained with proper documentation.

Documentation and Evaluation:

The employee shall first be given documentation training on how the task is to be performed. This may consist of an SOP, manual, book, or simple outlined instructions. An SOP requires that the employee reads and studies the document, and at some point after they understand the SOP.The mode of training shall be either oral/ verbal counseling or through audio/ visual presentations prepared as modules or self- reading through printed material.The self reading mode is mostly preferred for trainer this shall be encouraged for personnel who are trained on the subject previously specially for the on job related training.
Each employee has to ensure, that their training file must have :
  • Induction program for new recruitment,
  • Employee Specimen Signature Card,
  • Training need identification form,
  • Training Certificate (In case of fresher only),
  • Job responsibility,
  • Questionnaires, progress card,
  • Annual calendar &
    Skill matrix.
  1. Those training in case of any external training; SOP revision; NCRs, deviations, change control, out-of-specification, out-of-trend, failure investigation, audits, market complaints, etc. and all specific trainings not mentioned in the schedule shall be considered as unscheduled training and shall be documented in the Training Progress Card, training attendance shall be attached in the originating document such as Change control, Deviation, Market complaints etc.
  2. If in the case of on long leave (more than 30 days), the training missed by him/her shall be taken on his/her re-reporting, and all these shall be treated as unscheduled if the schedule month passed away.
  3. The trainees shall be evaluated through written questionnaire or orally. In case of written evaluation of score is less than 100%, the trainee requires to be retrained for their better understanding. In case of oral evaluation, trainers themselves shall adequately check the efficacy of the training and shall decide whether training is satisfactory or retraining is required.
  4. Retraining requirements shall be identified for the individual during such evaluation by the evaluator. There is no need for re-entry of the retraining in the training progress card if retraining is carried out same day, but the original questionnaire sheet should be attached with the individual training file & retraining Questionnaires have the mark retraining on the top of questionnaires. Retraining attempt shall be maximum three times for each topic. If the candidate fails to qualify the retraining in the all attempts, the concern manager shall re-identify the training need or need for change in job profile.
  5. Employee shall be responsible for keeping his Training File in safe custody and able to produce at the time of need. If any employee leaves the organization, then his/her training records shall be submitted to HR dept. and maintained for a minimum period of six years from the date of relieving of the employee. In case if employee is permanently transferred to another unit, his file shall also be forward to that location.

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