TRAININGS
FUNCTION
Organize and conduct trainings to all
employees.
RESPONSIBILITY
HRD is the responsible to co-ordinate the
trainer,trainee and department heads
monitor the schedule.
QA Department is Monitoring the
trainings.
TYPES OF TRAINIGS
Induction orientation training.
Functional training /GMP training/GLP
training.
On the job training.
External training
SOP training.
Training to External contract work agencies
personnel.
INDUCTION ORIENTATION
TRAINING
Responsibility:
Head HR or His deputy.
INDUCTION
CONTENTS
Brief the company profile
Functions of various Departments
Policies and procedures
Administrative policies
Rules and Regulations
Personnel Hygienic
ORIENTATION
Orientation Training Schedule shall be
Prepared for new Recruits by Head HR /
his Deputy.
Head HR or his Deputy shall introduce the
new recruit to all the Heads of
departments.
ORIENTATION CONTENTS
Personnel safety Training
Orientation Training on QA systems
Orientation Training on Connected
Departments
Orientation Training on Job Specific
Training
FUNCTIONAL TRAINING/GMP
TRAINING/GLP TRAINING
Introduction: Functional training Schedule
and Training Planner should be prepared
by Department Heads or his Deputy.
Responsibility: In Coordination with Head
QA and Concerned Departments Heads.
Organizing: HR Department is
Responsible for Organizing.
FUNCTIONAL TRAININGS
TOPICS
Activities / Operations,
Safety
Regulatory Guidelines
cGMP
GLP
ON THE JOB TRAINING
The Training will be conducted “on the job”
by Departments head or his Deputy
Training shall be given on equipment,process
steps and precautions while operating,
handling and cleaning of the equipment.
Labeling and on-line documentation.
ON THE JOB TRAINIG
Precautions to avoid mix up with case studies
Training on-clean in place
Training on non-compliances observed at work
place
Information on any changes, training on
validation studies shall be given as part of on-the-
job training before making it effective
EXTERNAL TRAINING
External training will be imparted to
employees when training programs are
conducted by external agencies.
Heads of department identifies the trainees
and information regarding this shall be sent
to HRD to make necessary arrangements.
Employees are trained on the
following or relevant topics
cGMP Training on analytical
GLP equipment
GAMP Calibration and water
Training on safety systems
Validation techniques Material management
HVAC system
SOP TRAINING
Training should be given to all concerned
employees on the SOP, when a new SOP is
introduced or when an existing SOP is
revised
TRAINING TO EXTERNAL CONTRACT
WORK AGENCIES/PERSONAL
Training will be imparted to External
contract work agencies/personnel to make
them aware of the Organization
requirements.
Training on the following aspects shall be
given to contract work agencies/personnel
General safety Contamination and
precautions in their cross contamination
work area GMP
Personal hygiene, Movement in the
work place Specified areas like
cleanliness and good final product
processing areas
work habits
Laboratories and
Clean in place
manufacturing areas
Selection of Trainers
(Trainer Evaluation)
The trainer should have a minimum academic
qualification of Graduation in Science/
Engineering/ Material management/HR as
applicable in the respective discipline with a
minimum relevant work experience of 3 years.
All eligible trainers are certified to train by the
Head-QA and issued a certificate by the Head-
QA ‘ Certification of trainer’
EVALUATAION CRITERIA
Training will be assessed by written test or
an oral evaluation.
Questionnaire should contain not less than
5 questions.The trainee should obtain more
than 80% marks for qualifying
RE-TRAINING
The trainee who scores less than 80% will
be retrained and reassessed using a
different evaluation questionnaire.
The retraining session shall be conducted
on the same day or the next day of the
training session.
DOCUMENTATION
HRD informs by each department about
training programs held.
Training logs in support of the attendance
to training class should be sent to HRD for
verification.
HRD shall maintain a separate ‘Employee
training card’. The details are entered in
electronic format.
STORAGE AND LOCATION
OF TRAINING RECORDS
Quality Assurance department shall
maintain records of all employees.
Training records of employees who have
resigned from service shall be handed over
to HR Department.
