Trainer:
MD. ZAKARIA FARUKI
Manager & Head of Quality Assurance
Silva Pharmaceuticals Limited
Date of Training: March 20, 2023
Introduction
to the Training
Program
Slide 1 of 15
GMP

Training is a method of teaching, or developing in
oneself or others, any skills and knowledge or
fitness that relate to specific useful competencies.
Training has specific goals of improving one's
capability, capacity, productivity and performance.
What is Training?
The training or learning objectives are –
 Intended measurable outcome that the learners will
achieve once they've finished the training.
 Improve the individual's level of awareness.
Increase an individual's skill in one or more areas of
expertise.
Increase an individual's motivation to perform their job
well.
What are training objectives?
Slide 2 of 15
SILVA

Basic Principles
Slide 3 of 15
SILVA

Slide 4 of 15
SILVA
Objectives of training is to develop the
Personnel in the SMART:
 Specific
 Measurable,
 Action-oriented
 Realistic
 Time bound

1. Induction Training/ Orientation
*New Employee Orientation
 Getting to know your new assignment
 Familiarizing yourself with your new environment
 Meeting new colleagues
2. GMP Training: AS per WHO requirements
3. On Job Training: As per yearly training Calendar
 Learning Objectives
*Technology,
*Procedure,
*Policies,
*Benefits
Training at Pharmaceuticals Organization
Slide 5 of 15
SILVA

GMP: (Basic Principles)
GMP Training Components: Ref.
WHO Technical Report Series, No. 908, Annex 4
1. Quality Management System
2. Good Manufacturing Practice for pharmaceutical products
3. Sanitation and Hygiene
4. Qualification and Validation
5. Complaints
6. Product Recalls
7. Contract production, analysis and other activities
8. Self-inspection, quality audits and suppliers’ audits and approval
9. Personnel
10. Introduction to the Training Program
11. Personal Hygiene
12. Premises
13. Equipment
14. Materials
15. Documentation
16. Good Practices in Production and
17. Good Practices in Quality Control
Slide 6 of 15
SILVA

1. The manufacturer should provide training in
accordance with a written programme for all
personnel whose duties take them into
manufacturing areas or into control laboratories
(including the technical, maintenance and
cleaning personnel) and for other personnel as
required.
2. Besides basic training on the theory and practice
of GMP, newly recruited personnel should receive
training appropriate to the duties assigned to
them. Continuing training should also be given,
and its practical effectiveness periodically
assessed. Approved training programs should be
available. Training records should be kept.
Basic Principles
Slide 7 of 15
SILVA

3. Personnel working in areas where contamination is a
hazard, e.g. clean areas or areas where highly active, toxic,
infectious or sensitizing materials are handled, should be
given specific training.
4. The concept of QA and all the measures which aid its
understanding and implementation should be fully
discussed during the training sessions.
5. Visitors or untrained personnel should preferably not be
taken into the production and QC areas. If this is
unavoidable, they should be given relevant information in
advance (particularly about personal hygiene) and the
prescribed protective clothing. They should be closely
supervised.
6. Consultant and contract staff should be qualified for the
services they provide. Evidence of this should be included
in the training records.
Basic Principles (Contd…)
Slide 8 of 15
SILVA

A quality training is one that meets all eight standards. To
meet a standard, your training must address each
required attribute. Also your training should address the
additional attributes (listed below the required attributes)
if they apply to your specific learners or training goals.
Training must meet all eight standards to be a Quality Training-
1. Training NEEDS ASSESSMENT informs training development
2. Training includes LEARNING OBJECTIVES
3. Training content is ACCURATE AND RELEVANT
4. Training includes opportunities for LEARNER ENGAGEMENT
5. Training is designed for USABILITY AND ACCESSIBILITY
6. Training EVALUATION informs improvement
7. Training includes opportunity for LEARNER ASSESSMENT
8. Training includes FOLLOW-UP SUPPORT for the learner
What is quality training?
Slide 9 of 15
SILVA

Advantages Of Training Program are-
Increased efficiency of employees
Reduced supervision
Less amount of wastage
Reduced turnover
Helps new employees in the organization
Better labour management relations
Self-confidence
Increased motivation levels
What are benefits of training?
Slide 10 of 15
SILVA

There are several types of training we can
provide for employees. In all situations, a variety
of training types will be used, depending on the
type of job.
1. Technical or Technology Training
2. Quality Training
3. Skills Training
4. Soft Skills Training
5. Professional Training and Legal Training
6. Team Training
7. Managerial Training
8. Safety Training
Types of Training…..
Slide 11 of 15
SILVA

*TRAINING: Training means the process of increasing the knowledge
and skills of an employee for doing a particular job. It seeks to
improve the job performance and work behaviour of those trained.
*QUALIFIED TRAINER: Person who has the recognized qualifications
in training in respective topics is called qualified trainer.
*DESIGNATED TRAINER: Person who has adequate knowledge &
capable to provide training on respective topics is designated as a
trainer by the Head of the Department is called designated trainer.
*QUALIFIED ASSESSOR: Person who has the recognized
qualifications in assessment is called qualified assessor.
Technical training addresses software or other programs that
employees use while working for the organization.
Quality training is a type of training that familiarizes all employees
with the means to produce a good-quality product. The ISO sets the
standard on quality for most production and environmental
situations. ISO training can be done in-house or externally.
Key Takeaways…
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SILVA

Skills training focuses on the skills that the employee actually
needs to know to perform their job. A mentor can help with this kind
of training.
Soft skills are those that do not relate directly to our job but are
important. Soft skills training may train someone on how to better
communicate and negotiate or provide good customer service.
Professional training is normally given externally and might be
obtaining certification or specific information needed about a
profession to perform a job. For example, tax accountants need to
be up to date on tax laws; this type of training is often external.
Team training is a process that empowers teams to improve
decision making, problem solving, and team-development skills.
Team training can help improve communication and result in more
productive businesses.
To get someone ready to take on a management role, managerial
training might be given.
Safety training is important to make sure an organization is meeting
OSHA standards. Safety training can also include disaster planning.
Key Takeaways…
Slide 13 of 15
SILVA

Time Spent
Projects
Worked
On
Get Familiar
Achieve
Mastery
*Working Toward Mastery
Get
Experienced
Slide 14 of 15
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