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  1. 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
  2. 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
  3. Basic Principles Slide 3 of 15 SILVA
  4. Slide 4 of 15 SILVA Objectives of training is to develop the Personnel in the SMART:  Specific  Measurable,  Action-oriented  Realistic  Time bound
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  12. *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… Slide 12 of 15 SILVA
  13. 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
  14. Time Spent Projects Worked On Get Familiar Achieve Mastery *Working Toward Mastery Get Experienced Slide 14 of 15 SILVA
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