The need for continual training program as a part of cGMP in pharmaceutical industries
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Transcript of The need for continual training program as a part of cGMP in pharmaceutical industries
THE NEED FOR CONTINUAL TRAINING PROGRAM AS A PART OF cGMP IN PHARMACEUTICAL INDUSTRIESReg no. 160617009
Presented by Ms. SHIKHA Y. SINGH
Under the guidance of Dr. GIRISH PAI K.
DEPARTMENT OF PHARMACEUTICS
MCOPS MANIPAL UNIVERSITY
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INDEX INTRODUCTION
CONTINUAL cGMP TRAINING
TRAINING POLICIES & PROCEDURE
CONTINUAL TRAINING PROGRAM
NEED OF CONTINUAL TRAINING PROGRAM
cGMP REQUIREMENTS
CONCLUSION
REFERENCES
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INTRODUCTION Every organization in regulated industry must train its employees
This training is scheduled in several ways
Refresher training may be schedule more frequently than on an annual basis
According to the USFDA
Rather than referring to “ANNUAL” cGMP refreshing training
CONTINUING cGMP
training
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Basic scheduling distinction between
training that is delivered
In response to a
perceived deficiency
Training deliver
according to calendar
New employee orientation NEO
Training for business process redesign & SOP revision
Technical training
Much of regulatory training---periodic refresher training that is mandated in cGMP
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CONTINUAL cGMP TRAINING FDA regulations call for continuing cGMP training The training in cGMP
Shall be conducted by QUALIFIED INDIVIDUALS
Shall be conducted on a CONTINUING BASIS
Shall address cGMP REQUIREMENTS
With SUFFICIENT FREQUENCY
Employees should remain FAMILIAR with cGMP requirements
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TRAINING POLICIES & PROCEDURE
Scope
Trainees
Curricula
Training plansCourse development &
acquisitionTraining materials
Training administrationChange control to training
materialAssessment & evaluations
Instructor & trainers
Training records
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CONTINUAL TRAINING PROGRAM
Orientation training for new
employees
Work-specific
area training
Ongoing training
Remedial training
Job-change training
Trainers training
Supervisor &
manager training
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ORIENTATION TRAINING FOR NEW EMPLOYEES Should be as simple as possible New employees- will not understand GMP rules during their 1st day
in the company Training new employees in cGMP is an extremely critical activity Employees never exposed to cGMPs
NEW EMPLOYEE-
ORIENTATION TRAINING
PHASE-I PHASE-II
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PHASE IHistory of the company
Organizational chart
FacilitiesCompany policies & company standard practices Basic GMP concepts
General safety trainingCarried out during the employee’s 1st day in the company
PHASE II Location of the working area Characteristics of the working area
Product knowledge
Job description
Work-specific training programme
Basic documentationCarried out during the employee’s 1st week in the company
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WORK-SPECIFIC AREA TRAINING Employee whose activities could impact on the quality of the
product should receive work-specific training at the time of joining the company and on a continuing basis
Work-specific area training should cover
three aspects
Safety trainin
g
On-the job
training
CGMP trainin
g
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1. cGMP TRAINING Training should be completed in 1st two months following entrance
in the company To ensure that employees understand & follow cGMP requirements
applicable to their jobs • Manufacturing of products
• Aseptic processing
• QC• QA• Animal
facilities • Product
development• Visual
inspection & packaging
• Warehousing & distribution
• Maintenance• Purchasing
Specific CGMP training-
developed according to CGMP requirements for
each area
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2. ON-THE JOB TRAINING Frequently underestimated Not performed in a very professional way New employee is simply assigned to the most experienced one to
watch New person learns same practices–some bad, some good of the
experienced person Supervisor is responsible for this training Based on the SOPs & acquisition of technical skills needed for the
job Particularly important at this stage to teach the trainee not only
what he/she should do & how but why it must be done in such a way Also known as STRUCTURED on-the-job training Should include having a checklist of topics & preferred sequence in
which they are to be covered
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TRAINING ON SOPS• Supervisor will provide the current copy of the SOP related to the task & allocate time for reading
• Trainee will read the pertinent document
• Supervisor will review the SOP with the trainee & will answer any questions regarding the documents
• Supervisor will show the trainee how to do the task
• Trainee will perform the procedure under supervision
• Supervisor will review the work in such a way that positive performance will be reinforced
• A checklist to evaluate the performance of the trainee
• Then trainee will perform the procedure without supervision
• When the supervisor is satisfied with the trainee’s performance, the supervisor and the trainee will sign the training record
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3. SAFETY TRAINING
Safety training will be developed from the specific safety requirements for the area
It will be given to all those employees in at-risk occupations Safety department identifies those who need to have safety
training, which may be given individually or to a group of employees in related occupations
According to the existing risks & complexities. These should cover:
Knowledge of mechanisms of exposure to the specific risk agent including toxic chemicals & biohazards
Appropriate use of personal protection itemsHow to proceed in an emergency
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ON-GOING TRAINING Also known as reinforcement training, refresher training,
continuous or periodic training Conducted to update, reinforce & refresh the knowledge and skills
of employees
cGMP
On-the job training
Safety training
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REMEDIAL TRAINING Remedial training is given when there is evidence that the original
training was not adequate, resulting in a person who cannot correctly, safely, effectively or efficiently perform the task
Remedial training is frequently used incorrectly, as corrective actions to failures
“Retrain the operator” or “retrain the lab analyst” It should be planned when specific deficiencies related to training
are identified during the performance of a job or task It may only need to emphasize why the correct, required way must
be done & potential outcome of shortcuts
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Useful when employees have forgotten their knowledge & skills after a long absence from the job or by infrequent assignment to a job or task
Supervisor provides the current copy of the SOPs
Trainee rereads the SOPs
Trainee performs, under supervision, the procedures he/she was originally trained in
Trainee performs the procedures without supervision
Supervisor is satisfied with trainee’s performance, supervisor and the trainee sign the training record
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JOB-CHANGE TRAINING Defined training program consider the training needs of someone
who moved from one position in the company to a new position Adequate training must therefore be given to every employee
when she/he is assigned to a new job function Work-specific training should be conducted for the employee’s
new needs Job change training may be organized in following way
Review employees training record
Review training requirements for new job position
Prepare a training plan for employee based on analysis
Perform trainee’s assessment
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SUPERVISOR & MANAGER TRAINING Supervisor training It is the responsibility of the supervisor
To provide clear direction to lead by To set high standards of performance To provide feedback To ensure adequate resources
Supervisor training should be conducted to guarantee that supervisors be adequately trained in:
Areas they are going to supervise SOPs used in their department Their responsibilities under cGMP Change control
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Manager training Quality, motivation & education are very closely related- Managers
plays an important role in motivating their staff Training should be carried out from the top to the bottom of the
staff & with managers involved as much as possible Managers should learn to communicate effectively with
supervisors & subordinates and also to learn diverse ways to motivate & encourage their staff
Managers and supervisors need to be trained in their responsibilities under cGMPs & Good laboratory practice (GLPs) for non-clinical studies
Managers and supervisors should also be trained in aspects such as:
Communication Motivation Decision-making Problem solving
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TRAINER’S TRAINING Trainers should have an understanding of how trainees learn & in
providing effective feedback to trainees Desire to train, help others & continually learn are traits trainers
have in common Trainers need to continually develop their skills as communicators
& coaches“Andragogical model”- (adult learning theory) It states that adults are self-paced learners who need
involvement, visualization & a clear connection between new & existing information that they already have
Adults are motivated to learn if they can see the value & benefit that the knowledge can contribute to their lives or situation
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NEED OF CONTINUAL TRAINING PROGRAM Dynamic process that cannot be satisfied by a single training
course to be given to an employee at the time of hire
Investment in people that pays its dividends in a more skilled workforce, improved productivity & higher levels of product and service quality
DYNAMIC PROCESS
Training an employee receives in
his/her career
Keep pace with job requirements & performance expectations
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More training is required when… Less training is required when… The workforce is relatively new to
the jobThe workforce is experienced
There is a high, rapid employee turnover rate
There is a low employee turnover rate
New products are being added No new products are being addedThere are some/many worker
performance issuesThere are few worker performance
issuesThe technology, equipment, or
process is new or changingThe technology, equipment, or
process is stableNew personnel are added; the firm is
expandingFew new personnel are added; the
firm is staying the same size The facility operates 24hours a day
using multiple shiftsThe firm operates on one shift
There are gaps between what a person can do when hired & what
he is required to do
There is a close match between knowledge & skills of personnel &
what is required of them
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SOME EXAMPLES OF HOW TRAINING HAS HAD AN IMPACT ON PEOPLE AND ORGANIZATIONSDuring cGMP training
course:Materials-handling personnel at a firm making biological products, contamination & product purity People were washing their hands One washed & other unwashed – on culture media plates (Petri dishes)Record-keeping techniquesNo. of “first-time-right” batch records greatly increased-QA review time
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cGMP REQUIREMENTSAs per WHO-cGMP: The manufacturer should have an adequate number of personnel
with the necessary qualifications & practical experience All personnel should be aware of the principles of cGMP that affect
them & receive initial and continuing training relevant to their needs
The manufacturer should provide training in accordance with a written programme
Newly recruited personnel should receive training appropriate to the duties assigned to them
Continuing training should also be given & its practical effectiveness periodically assessed
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CONCLUSION FDA recommends that cGMP training not be conducted in one
massive training session Rather, it should be presented in smaller more manageable
sessions held throughout the year, or at a minimum be held once a year
cGMP training should be revisited at frequent intervals & needs to be conducted by qualified individuals
cGMP Regulations indicates that “Training should address the policies, processes, procedures & written instructions related to operational activities, the product/service, the quality system, and the desired work culture”
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REFERENCES A WHO guide to good manufacturing practice (GMP) requirements
– Part 3: Training printed by the WHO Document Production Services, Geneva, Switzerland
Guidance for Industry Quality Systems Approach to Pharmaceutical cGMP Regulations
"Developing a Continuing cGMP Training Program," Journal of GXP Compliance, Vol. 13, No. 4, Fall 2009, pp. 86-96.
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ANY QUERIES???
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