Wednesday, November 24, 2010

Training

Purpose    :   To lay down guidelines for training of new entrants and periodic retraining of technical staff.

2.0 Objective   :  To Provide Documented Procedure for training of new entrants and periodic retraining of technical staff.

3.0   Scope        :  To define role/responsibility of various functions responsible for technical training.

4.0     Responsibility    :
o             Q A Manager
o             Q C Manager
o             Production Manager
o             P & A Manager

5.0      Procedure   :
·        New entrants:
Ø      New entrants to the organization shall be given induction training and brief cGMP/GLP training by Manager QA within 10 days of joining.
Ø      New entrants should be given technical training (need based) by the departmental manager depending upon the nature of job for one month.
Ø      New entrant should be instructed to observe the activity in the recruited department for one month after the initial induction program.
Ø      A written feedback is collected from new entrants after the training to ascertain his/her competence in both technical and cGMP skills.
Ø      QA Manager shall prepare a regular annual schedule for training/retraining of technical staff.
Ø      The Qualified trainer who has conducted the training should review and assess the feedback.
Ø      Based on the assessment, trainer shall identify training retraining needs.
Ø      Individual Training record should be maintained for each new entrant along with their feedback.
·        Regular Training
Ø      Based on the need/requirement, a schedule along with a module should be prepared for the staff and accordingly training session should be conducted.
Ø      A training session by the Unit departmental manager should be conducted for the following:
ü      If any critical changes are made in the Standard Operating Procedure, training has to be conducted to the concerned departmental personnel.
ü      If any new equipment is installed, the staff and the operator have to be trained on the operation, cleaning, Maintenance and trouble shooting for the equipment.
ü      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.
ü      Analytical method will be explained to the Quality Control personnel by the manager.
Ø      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.
Ø      List of participants with their signatures should be documented during the training session by the Quality Assurance department.
Ø      The trainer should prepare a questionnaire based on topics covered and issue it to the participants.
Ø      The participants should write their answers and submit it to the trainer.
Ø      The trainer should assess the participants based on their feedback.
Ø      Based on the trainer’s assessment, retraining requirement should be identified by the trainer.
Ø      The Quality Assurance personnel should file participants feed back in their respective training record.
Ø      For any minor changes in SOP or process, the Qualified Trainer should give training at the work place and the same should be documented.
·    External training
Ø      External training will be imparted to chemists, Officers / Executives and other personnel based on the needs. Normally following training topics are covered under this training.
ü         cGMP (current Good Manufacturing Practice).
ü         GLP (Good Laboratory Practice).
ü         Validations.
ü         Regulatory aspects.
ü         Other topics as appropriate

Ø      External training shall be recorded in the individual training cards, no specific formats /Logs are maintained for this kind of training. Training evaluation record shall be maintained.
·        Training schedule
Ø      New entrant
ü         General factory rules and cGMP –10days
ü         Technical training – one month
Ø      Regular training for staff and operators
ü            cGMP – Once in 6 months
ü            GLP - Once in 6 months
ü            Technical training – Once in 3 months
Ø      A training session by an External Agency shall be conducted as and need/opportunity arises.
Ø      Apart from the schedule, training/retraining sessions will be conducted as and when need arises.

6.0          Reference Document  :    Not applicable

7.0          Abbreviations  :
·                cGMP: Current Good Manufacturing Practice
·                GLP: Good Laboratory Practice


8.0          Copies to  Distribution Sites :
·                    QA 
·                    P & A
·                    QC
·                    Production

9.0          Enclosure :

·                     Annexure – I: Induction Training Format.

·                     Annexure – II: GMP / on job Department Training Log.

·                     Annexure – III: GMP/ on Job Training Report Format.

·                     Annexure – IV: Employee Training Card.


ANNEXURE-I

INDUCTION TRAINING FORMAT

Issued By:
(Executive – P & A)
Topic: INDUCTION TRAINING
Name of the Employee:

Designation:
Dept:
Date of joining:

Remarks After training by Executive – P & A


Remarks After training by Head - Q.A

Conducted By
1.
2.
Sign
Date

Note:-One form shall be filled for each employee






ANNEXURE-II
GMP / ON JOB DEPARTMENT TRAINING LOG

Name Of Trainer:

Date:
Designation


Location:

Duration of Training:
Title Of Training

Topics Covered


S. No.
Name Of Employee
Designation
Department
Employee Signature
Trainer Sign


























































ANNEXURE-III

GMP/ ON JOB TRAINING REPORT FORMAT

Issued By: Head - Q.A
Sign     :
Date    :
Dept    :
Topic:

Date    :
Demonstration / Explaining  / Counseling / Class room training
(ü which ever it appropriate)

Brief description/ Review:

Type of Evaluation
Written / Oral
Trainer Name:



Sign





 

ANNEXURE – IV

EMPLOYEE TRAINING CARD

                                                                                                                                               
NAME                    :                                                                            DATE OF JOINING:

DEPARTMENT    :                                                                              DESIGNATION:                                

SR
No.
Date of Training
Topic
Mode of training
Mode of Evaluation
Sign of Employee
Remarks by Trainer
Name & Sign of Trainer
Sign of Dept. Head




Written / Oral
Written / Oral







Written / Oral
Written / Oral







Written / Oral
Written / Oral







Written / Oral
Written / Oral





All kinds of training programs attended by the participant shall be recorded in the following format. These formats are maintained one individually for the each employee.  

No comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...
Subscribe to Quality Assurance and GMP by Email