Hetero Healthcare Training Programme SOP PDF

STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date...

STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 1 of 20 Prepared By Reviewed By Approved By Name Designation Sign Date 1.0 OBJECTIVE 1.1 To lay down a procedure for training of personnel associated with manufacturing, packing, holding, testing, and distribution of drug products. 2.0 SCOPE 2.1 This procedure is applicable to Hetero Healthcare Limited, Unit-II, Formulation division, Assam. 3.0 RESPONSIBILITY 3.1 Training coordinator shall develop the training plan, conduct Induction Training, cGMP Training, Refresher cGMP Training, Retraining, identify training requirements, ensures proper Execution of the training events and their documentation and is involved in reviewing the level of success. 3.2 Concerned Department Head/Designee shall conduct On-the-Job Training, Retraining, Specific Training and to identify the training requirements of individual employees and responsible for monitoring the qualification of their staff. 3.3 Head QA or designee shall conduct Ethics Training. 3.4 Trainee shall attend the training programs as and when informed, and respond to Question through paper /verbal as applicable. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 2 of 20 3.5 Head QA is responsible for the implementation / compliance of the procedure. In case any departmental Head/ Designee (trainer) is absent for imparting training, Head QA/ Designee can impart training. 4.0 PROCEDURE 4.1 Training: Training is acquisition of Knowledge, Skills and competencies as a result of the teaching of Vocational/Practical training skills and knowledge that relate to specific useful competencies. Training has specific goals of improving capability, capacity and Performance. 4.2 Trainer: A person who teaches people to perform a particular job (or) skill. 4.3 Trainee: A person who is learning and practicing the skills of a particular job. 4.4 Training Planning 4.4.1 Regular training of employees is a significant requirement for employees being able to complete their jobs in accordance with cGMP. 4.4.2 Training coordinator determines the need for training and learning objectives in close collaboration with Head of different departments and executes the planning. 4.4.3 Training should be planned in the form of approved training programs and must be periodically assessed and recorded. Training of unskilled temporary staff must be given particular attention. 4.4.4 Training should be on continuing basis and with regular frequency. It should include all the topics related to concern departments. 4.5 Training to Trainers 4.5.1 Quality Assurance Head / concerned department head shall depute their department Personnel for external trainings on cGMP programmes. After completion of training, personnel who has undergone for the external training shall conduct the training to all trainers internally or training can also be conducted for all trainers by the external training agency / Quality Assurance Head once in a year. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 3 of 20 4.5.2 Trainers should have an understanding of how personnel learn and in providing effective feedback to trainees. 4.5.3 Trainers should also understand the best ways to teach tasks and procedures. 4.5.4 Group trainers should have “presentation skills” to use various training media and methods and know how to respond to questions and difficult situations. 4.5.5 Trainers who are involved in producing training courses and materials, should cover the training in “Course Development” (e.g. Instructional systems design process). 4.6 Identification of Trainer: 4.6.1 Trainer should have the following Requirements 4.6.1.1 Extensive technical Knowledge and experience more than 5 years of experiences in relevant area. 4.6.1.2 Practical knowledge on the subject in which he is going to give training. 4.6.1.3 Good communication skill 4.6.1.4 A great desire to train 4.6.1.5 Ability to get people to participate and a strong desire to meet trainee’s needs 4.6.1.6 Ability to motivate, humour and creativity. 4.6.1.7 Self-critical control of learning objectives. 4.6.1.8 Apart from the subject knowledge shall also have good interpersonal communication skills. 4.6.2 Trainer shall be the immediate supervisor or department head as applicable. 4.6.3 Each trainer should undergo training in their Departmental SOPs. The assessment of trainer can be done through document reading. 4.6.4 The “List of Trainers” shall be updated based on the competency and availability of trainers as and when required (Refer annexure: 2QA003/A12). Addendum for List of Trainers (refer Annexure: 2QA003/A23) shall be prepared by QA when required 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 4 of 20 (increase in experience required for trainers, change in designation) same shall be updated in the List of Trainers on half yearly basis by QA. 4.6.5 List of Trainers shall be prepared/revised and uploaded by User department through EDMS, however; during preparation/ revision of List of Trainers, same template to be used but only there will be auto-generation of header and footer from EDMS and electronic signature to be done instead of manual signature. 4.6.6 Trainer evaluation shall be documented with Resume of trainer as per Annexure No. 2QA003/A22 (Title: Trainer Resume). Certificate of trainer authorized by Head - Quality Assurance as per Annexure No. 2QA003/A13 (Title: Certification of Trainer). 4.7 Methods of Training: 4.7.1 Power point Presentation (Slides, Films, Videos and CD-ROM) & Visual Aids 4.7.1.1 The classical lesson form, teacher speaks and the participants listen - is appropriate in principle if dealing with the communication of subject matter. 4.7.1.2 All the Audio-Visual techniques (Visual Aids) have the advantage that they make the subject matter “more visible” in the time sense of the word, and this also more easily accessible; they are very effective media to reinforce what the speaker is saying; they help trainers explain their ideas in a different form other than in words. 4.7.2 Working groups 4.7.2.1 Working groups are generally used to obtain more depth knowledge and require previous knowledge. 4.7.2.2 It promotes active involvement of the participants and are useful for active thinking and learning. 4.7.2.3 The advantage of working groups is that each individual participant is more intensively involved in lesson, in comparison with other methods and also when a subject is complex and there are multiple points of view. 4.7.3 The mode of imparting training shall be through a combination of one or more of the following: reading procedures, presentation, practical training, discussion and questionnaire. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 5 of 20 4.7.4 Practical or demonstration of job / work / activities 4.7.4.1 In order to present training program effectively, the trainer will demonstrate the practical exercises. E.g.: practical demonstration of dress code system for employees entering to the grade C area. 4.7.5 E – Learning 4.7.5.1 A series of computer – assisted interactive learning program, allow knowledge to be tested via multiple choice tests (or) case studies. The E-Learning method having advantages of reduction of training costs and time off, consistent quality of training measure. 4.7.6 Skit 4.7.6.1 Skits can be used to promote discussion and thinking. Skits usually follow a script that is written in advance. At the end of a skit, the facilitator can guide the discussion toward points that are important to cover. 4.8 The training Programme should include the following kinds of trainings (refer annexure 2QA003/A01- Flow chart for training) but not limited to 4.8.1 Induction Training 4.8.2 On the job Training 4.8.3 cGMP Training 4.8.4 External Training 4.8.5 Other Training 4.8.5.1 Refresh(or) Requalification Training 4.8.5.2 Technical Training 4.8.5.3 Practical Training 4.8.5.4 Specific Training (Remedial Training) 4.8.5.5 Manager Training 4.8.5.6 Training to Housekeeping & Contract Staff 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 6 of 20 4.8.5.7 Ethics Training 4.8.5.8 Safety Training 4.8.5.9 Other Training 4.9 Induction Training 4.9.1 Induction training includes an overview of organization and user department. All employees shall undergo induction training. 4.9.2 HR Department & respective department Head shall fill the “New Joinee Report” (Refer annexure: 2QA003/A03) and forward to QA department along with the new joinee for induction training. 4.9.3 Induction training program shall be organized, so that new employee is introduced with the interacting departments, staff members and gets familiarized with the overview of organization and department. 4.9.4 Training coordinator of QA shall prepare the Pre-induction schedule for conducting induction training of each new employee in the “Induction Training Schedule” (Refer annexure: 2QA003/A05) by mentioning the date and Department where the induction to be carried out and the same pre-schedule after preparation shall be acknowledged by Head QA/ Designee. Trainer shall fill the time in the schedule as per completion of Induction in the concerned departments. 4.9.5 New employee shall be introduced by HR department to the training coordinator, who is responsible to help the new employee through the induction period and beyond. 4.9.6 The topics of induction training program shall cover the following 4.9.6.1 Company Profile 4.9.6.2 Quality Policy 4.9.6.3 Safety Policy 4.9.6.4 Objectives 4.9.6.5 Organogram, 4.9.6.6 General Instructions for Entry & Exit into Plant Premises 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 7 of 20 4.9.6.7 Maintenance of Cleanliness in the Plant Premises 4.9.6.8 Personal Hygiene. 4.9.6.9 Overview of the department to familiarize with staff and understand the organograms, sections and basic processes and interdependence in relation to his / her job responsibilities. 4.9.6.10 At the end of the induction training new employee shall prepare a brief report of the activities seen in “Induction Training Report” (Refer annexure: 2QA003/A04) format and shall list suggestions if any and forward the report to the home department head for evaluation. 4.9.6.11 The concerned department head or his designee and Head QA or designee shall evaluate the report and shall take appropriate action(s) based on the suggestion(s) recommendation(s) made by the new employee. 4.9.6.12 At the end of the induction training new employee shall put his specimen signature in specimen signature record (refer SOP No.: 2QA004). 4.9.6.13 After recording of specimen signature HOD shall assign the job responsibilities (refer SOP no.: 2QA005). 4.10 On the Job Training for New Employee: 4.10.1 On the job training shall include training in depth of the user department and cross functional departments of the new employee. 4.10.2 On-the-Job Training based on the assigned job responsibilities will be planned accordingly. 4.10.3 A detail schedule for on the job training based on the assigned job responsibilities shall be prepared and approved by concerned department head. (Annexure 2QA003/A06) 4.10.4 On the job training program shall include the training related to the specific aspects of an individual’s role including use of equipment, unit operations, safety norms to be followed, adherence to cGMP, assigned responsibilities etc. 4.10.5 The mode of imparting training shall be through a combination of one or more of the following: reading procedures, Presentation, Practical training, discussion and questionnaire. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 8 of 20 4.10.6 The mode of training shall be through Self-reading for Assistant Manager and above designation. 4.10.7 The questionnaire for the evaluation of a trainee shall be prepared by user department as per (Annexure: 2QA003/A08). 4.10.8 After successful completion the on-the-job training, trainee shall prepare a brief report on details of training undergone in “On the Job Training Report /Evaluation” (Refer annexure: 2QA003/A07) format. A duly signed certificate is issued to trainee by concerned head and QA head after evaluation of the training report as per annexure 2QA003/A09. 4.10.9 If a person is transferred from one department to another, the training coordinator shall be informed. 4.10.10 The Head of the new department in such circumstances shall initiate a separate on- the-job training. 4.11 cGMP Training 4.11.1 cGMP training includes various chapters covered as per different regulatory guidelines for cGMP. All employees who are directly associated with manufacturing, packaging, holding, testing and distribution process shall undergo such training. 4.11.2 This program shall be mandatory for all employees (New and Existing) and shall cover the regulatory requirements of the countries being catered. 4.11.3 Basics of cGMP training shall be imparted to every new joiners during induction process and every month to employees through ‘cGMP Training Schedule’ as per annexure 2QA003/A16 4.11.4 “cGMP Training Schedule” as per annexure 2QA003/A16 shall be prepared/ revised and uploaded by QA through EDMS. However, during preparation/ revision of cGMP Training Schedule same template to be used but only there will be auto- generation of header and footer from EDMS and electronic signature to be done instead of manual signature. 4.11.5 In case of any EDMS breakdown/server problem all the activities shall be done manually (refer SOP: 2QA068) and for manual numbering in document refer SOP No.: 2QA037. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 9 of 20 4.11.6 Numbering system for cGMP Training Schedule through EDMS (manual numbering): 4.11.6.1 2S/DC/GMP/YY- Ver. 0 4.11.6.2 The first character “2” Indicate Manufacturing Location unit. 4.11.6.3 S indicates “Schedule” 4.11.6.4 The next character is a '/' (slash) used for separator. 4.11.6.5 The two-character DC indicates department code 4.11.6.6 The next character is a '/' (slash) used for separator. 4.11.6.7 Next three characters are fixed as “GMP” 4.11.6.8 The next character is a '/' (slash) used for separator. 4.11.6.9 YY indicates last two digit of current year 4.11.6.10 The next character is “-” (dash) used as separator. 4.11.6.11 The next character is a single space. 4.11.6.12 Next character is the version number to be written alphabetically as Ver. 4.11.6.13 The next character is a single space. 4.11.6.14 The last characters denotes revision number of the Format/ Label as Version number - 1, 2, 3, 4, ……, 10, 11, …….. so on; an increment of 1 unit in the sequential order. 4.12 External Training 4.12.1 External training program shall include the training conducted by external institution or external faculty in the organization. 4.12.2 External training events are a good opportunity to find out about the latest knowledge and state of technology and offer the possibility of exchanging information with other companies. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 10 of 20 4.12.3 The concerned HOD shall depute the candidates for external training. 4.12.4 Trainee has to fill the ‘External training Feedback Form’ immediately after attending the training. (Refer annexure: 2QA003/A15). 4.12.5 Evaluation of the training effectiveness has to be done within one month from the date of training by Concerned HOD. Effectiveness can be evaluated based on implementation of the knowledge learnt during the training in the course of his day to day work performance. 4.13 Other Training 4.13.1 Refresh Training / Requalification Training 4.13.2 Regular training updates to personnel on key aspects on their role shall be chosen and training conducted. 4.13.3 All employees shall undergo Refresher training / Requalification on the procedures of their respective functions and related process or cross functional departments Wherever applicable. 4.13.4 Refresher training / Requalification shall be carried out whenever there is a Procedural change or revision before implementation. 4.13.5 On Job Training 4.13.5.1 On job training shall be given by the concerned department Head/designee who is capable for training and having adequate knowledge. The department head has the responsibility for selection of the trainer. 4.13.5.2 All departments Training Coordinator shall prepare “On job training annual schedule” for SOP training to cover all SOP’s of respective department in the current calendar year as per Annexure No.: 2QA003/A14. 4.13.5.3 “On job training annual schedule” shall be Prepared/ revised by user department through EDMS. However, during preparation/ revision of “On job training annual schedule” same template to be used but only there will be auto-generation of header and footer from EDMS and electronic signature to be done instead of manual signature 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 11 of 20 4.13.5.3.1 Manual numbering system for On-Job Training Annual Schedule through EDMS: 2S/DC/OJT/YY- Ver. 0 4.13.5.3.1.1 The first character “2” Indicate Manufacturing Location unit 4.13.5.3.1.2 S indicates Schedule 4.13.5.3.1.3 The next character is a '/' (slash) used for separator 4.13.5.3.1.4 The two-character DC indicates department code 4.13.5.3.1.5 The next character is a '/' (slash) used for separator 4.13.5.3.1.6 YY indicates last two digit of current year 4.13.5.3.1.7 The next character is a '- ' (dash) used for separator 4.13.5.3.1.8 The last two character denote revision number of the SOP as version number 0,1,2,3,4….10,11…..so on; an increment of 1 unit in the sequential order 4.13.5.4 Based on the On job training annual schedule, “on job training monthly schedule” as per Annexure No.: 2QA003/A20 shall be Prepared/ revised by user department through EDMS. However, during preparation/ revision same template to be used but only there will be auto-generation of header and footer from EDMS and electronic signature to be done instead of manual signature and target persons shall be identified for the particular SOP by the training coordinator. 4.13.5.5 In case of any EDMS breakdown/server problem all the activities shall be done manually (refer SOP-2QA068). 4.13.5.6 Auto-numbering system for Monthly On-Job Planner through EDMS: 2XXX/DC/MMM/01- Ver. 0 4.13.5.6.1 The first character “2” Indicate Manufacturing Location unit. 4.13.5.6.2 XXX indicate Monthly On Job. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 12 of 20 4.13.5.6.3 The next character is a '/' (slash) used for separator. 4.13.5.6.4 The two-character DC indicates department code 4.13.5.6.5 The next character is a '/' (slash) used for separator 4.13.5.6.6 The three character MMM indicate month 4.13.5.6.7 The two character indicate the serial number 4.13.5.6.8 The next character is a '- ' (dash) used for separator 4.13.5.6.9 The next character is a single space 4.13.5.6.10 The last character denote version number 0,1,2,3,4….10,11…..so on; an increment of 1 unit in the sequential order Example : 2MOJ/QA/APR/01- Ver. 0 4.13.6 Specific Training Programme (Remedial Training) 4.13.6.1 Training coordinator and concerned HOD shall identify the training requirements in association with Head Quality Assurance and conduct the training program with details in “Training attendance sheet” (Refer annexure: 2QA003/A02) with the help of following training indicators but not limited to: 4.13.6.1.1 Outcome of the compliance monitoring and any noncompliance raised by the internal and external audits. 4.13.6.1.2 Incident reporting system (Non-conformance), Change Controls. 4.13.6.1.3 Market Complaints. 4.13.6.1.4 Out of Specifications/Deviations. 4.13.6.1.5 Product recalls. 4.13.6.1.6 Based on the training requirements identified, Training coordinator and concerned HOD shall prepare the training schedule as and when needed. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 13 of 20 4.13.6.1.7 In case of market complaints, incidents, deviations or OOS, the concerned department shall prepare a specifically designed training Programme. 4.13.6.1.8 Based on the event all the concerned personnel who are likely to be involved in performing the activity shall be listed and the details shall be recorded in “Training attendance sheet” (Refer annexure: 2QA003/A02). 4.14 Manager Training 4.14.1 Managers should learn to communicate effectively with personnel and to learn diverse ways to motivate and encourage their employee. The following aspects may be included in the manager training: 4.14.1.1 Communication 4.14.1.2 Motivation 4.14.1.3 Decision-making and Leadership 4.14.1.4 Empowerment and Team building 4.14.1.5 Managing change 4.14.1.6 Time management and delegation 4.14.1.7 How to orient and train employee 4.14.1.8 Conducting productive department meetings 4.14.1.9 Performance appraisal and coaching 4.14.1.10 Manager Training shall be conducted for all Managers by any external agency/ Quality Head once in a year and shall be documented. 4.15 Technical Training 4.15.1 Technical training is designed to develop specific functional / cross functional skills and update the technical knowledge. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 14 of 20 4.15.2 Training coordinator and concerned HOD shall identify the training needs in association with Quality Assurance Head and record the details in “Training attendance sheet” (Refer annexure: 2QA003/A02) with the help of following training indicators but not limited to: 4.15.2.1 Various guidelines and regulatory requirements. 4.15.2.2 Various guidance documents released by regulatory agencies. 4.15.2.3 Outcome of feedback and expectations from personnel during the training program. 4.15.2.4 Based on the training identification, training coordinator and concerned HOD shall conduct the training. 4.16 Retraining Programme 4.16.1 Retraining shall be identified and imparted in the following circumstances. 4.16.2 Disqualification in the evaluation process of any training Programme. 4.16.3 Any deficiency noticed during self-inspections, audits or performance reviews. 4.16.4 Revision of SOP. 4.16.5 If personnel fail to meet the required standard even after repeated training, they should not be permitted to perform their duties after joint decision taken by HOD with the co-ordination of HR department. 4.16.6 If the person is absent/leave for the job more than 3 months re training shall be given on critical SOPs and revised SOPs with respective to his job responsibilities. 4.17 Training to Housekeeping & Contract Staff 4.17.1 Training shall be given to all Housekeeping & Contract staff working in Production/ Engineering/ Quality Assurance/ Warehouse/ Quality Control/ Microbiology/ Environment Health & Safety/ Information Technology/ Engineering Departments either on topics like Basics of cGMP, Contamination and Mix-up’s, Personal hygiene & Cleanliness, Behavior at work place, cleaning procedures and SOP’s which are relevant once in a month by any Departmental Trainer or earlier where ever required as per “Yearly Training Schedule for Casual Workers (Housekeeping & Contract staff)” (Refer annexure: 2QA003/A25). Training attendance record shall be archived in QA. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 15 of 20 4.17.2 The training shall be recorded in training format “Training Attendance Sheet” (Refer annexure: 2QA003/A02) either by signing or by writing the name only and evaluation shall be oral. 4.18 Ethics Training 4.18.1 This program shall be mandatory for employees (New and Existing) in all departments. 4.18.2 Ethics training should be planned as a part of induction Training to new employee and for all the employees on annual basis by Head QA. Ethics training shall include at least following but not limited to An overall view of company mission on data reporting and record keeping. Training on Company data integrity procedures. Training on Examples of improper documentation and data manipulation. Training on how and when to report data integrity issues and record keeping. Training on Emphasis on importance of proper written reports by employee. Training on in depth data monitoring and data integrity procedure documentation. Employees are required to understand that any infractions of the laboratory data integrity procedures shall result in a detailed investigation that could lead to very serious consequences including immediate termination, debarment or civil/criminal prosecution. 4.18.3 After Completion of training like on job training etc. training summary report shall be prepared as per annexure No.: 2QA003/A21 (Title: Training Summary Report). 4.18.4 Persons who could not attend the scheduled training shall be covered in subsequent sessions or shall be self-trained on the respective SOP/topic. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 16 of 20 4.18.5 Data Integrity Ethics Agreement 4.18.5.1 A written Data Integrity ethics agreement shall sign the employee after completion of training same shall be signed by department head and Head QA (Annexure 2QA003/A10). 4.18.5.2 The agreement states that the employee will not engage in any unethical practices with respect to data integrity and will not tolerate improper behavior in others, if observed or suspected and also fully aware of the consequences of failure to comply Data integrity procedures result in immediate termination, debarment or civil/criminal prosecution. 4.19 Evaluation and Certification of Training 4.19.1 Effectiveness of the training Programme shall be evaluated to ensure that it fulfils the intended requirements. 4.19.2 On completion of internal training program, the trainer shall evaluate through oral test, written test or a discussion or using workout sessions. 4.19.3 Trainee shall prepare detail report on his / her understanding of the training Programme in their respective report formats (Induction Training Report (Refer annexure: 2QA003/A04), On the Job Training Report (Refer annexure: 2QA003/A07). 4.19.4 Trainer shall review the training report to evaluate the understanding of trainee and certify the trainee. 4.19.5 Wherever, evaluation is done through questionnaires and answers available (prepared as per annexure 2QA003/A19) the trainee shall be certified as qualified and evaluation of the answers to be done by concerned department Training Coordinator, if he has scored minimum qualification mark, which shall be 80% of the total marks allotted to the questionnaires. 4.19.6 The trainees who have scored > 80% will be orally trained/instructed on the un scored Questionnaire. 4.19.7 If trainee fails to obtain the minimum qualification marks retraining shall be conducted. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 17 of 20 4.19.8 If personnel fail to meet the required standard even after repeated training, they should not be permitted to perform their duties after joint decision taken by HOD with the co-ordination of HR department. 4.19.9 Any revision/ change/ correction in Master Question or Answer shall be carried out through Change Request Note. 4.20 Training Reports 4.20.1 The concerned Trainer and Training Co-ordinator shall maintain all reports pertaining to training of employee and print as and when required. 4.21 Training Attendance Sheet 4.21.1 For all training programs attendance sheet is generated from the system (Annexure 2QA003/A02). 4.22 Training Card 4.22.1 All the training attended by the employee shall be tracked in the Employee training card (Annexure 2QA003/A11). 4.23 Training related data 4.23.1 All the training related information and data shall be maintained by Training Co- ordinator in the system. 4.24 Personnel Training File 4.24.1 At the time of joining, a training file as per annexure 2QA003/A018 shall be opened for each employee. 4.24.2 The Curriculum Vitae (refer annexure 2QA003/A17), induction training evaluation report, on-the job evaluation report, external training certificates and any other training related document of an employee shall be filed in the Personal Training File. 4.24.3 All the training documents shall be retained for a period of six years after the date of resignation or retirement. 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 18 of 20 5.0 ABBREVIATIONS 5.1 SOP - Standard Operating Procedure. 5.2 No. - Number. 5.3 QA - Quality Assurance. 5.4 E.g. - Example. 5.5 HOD - Head of Department. 5.6 HR - Human Resources 5.7 cGMP - Current Good Manufacturing Practices. 5.8 OOS - Out of Specification. 5.9 EDMS - Electronics Documents Management System 5.10 MOJ - Monthly On Job 6.0 REFERENCES 6.1 GMP manual by SCHEDULE-M 6.2 EU Guidelines for training (chapter 2) 6.3 A WHO Guide to Good Manufacturing Practice (GMP) requirements (Part 3: Training) 7.0 CIRCULATION LIST 7.1 Controlled copy -1 – QA 7.2 Controlled copy -2 – QC 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 19 of 20 7.3 Controlled copy -3 – PD 7.4 Controlled copy -4 – EN 7.5 Controlled copy -5 – WH 7.6 Controlled copy -6 – MB 7.7 Controlled copy -7 – HR 7.8 Controlled copy -8 – IT 7.9 Controlled copy-9 – ES 8.0 ANNEXURES 8.1 Annexure: 2QA003/A01 - Flow chart for training 8.2 Annexure: 2QA003/A02 - Format of “Training Attendance Sheet” 8.3 Annexure: 2QA003/A03 - Format of “New Joinee Report” 8.4 Annexure: 2QA003/A04 - Format of “Induction Training Report” 8.5 Annexure: 2QA003/A05 - Format of “Induction Training Schedule” 8.6 Annexure: 2QA003/A06 - On –the-job training schedule 8.7 Annexure: 2QA003/A07 - Format of “On- the -Job Training Report” 8.8 Annexure: 2QA003/A08 - Format of Questionnaire 8.9 Annexure: 2QA003/A09 - Format of “Training Certificate” 8.10 Annexure:2QA003/A10 - Data Integrity Ethics Agreement 8.11 Annexure: 2QA003/A11 - Training card 8.12 Annexure: 2QA003/A12 - Format of “List of Trainers” 2QA001/F01-00  STANDARD OPERATING PROCEDURE SOP No. 2QA003–01 Title TRAINING PROGRAMME Effective Date Review Date Department Quality Assurance Page No. 20 of 20 8.13 Annexure: 2QA003/A13 - Format of “Certification of Trainer” 8.14 Annexure: 2QA003/A14 - Format of “On Job Training Annual Schedule” 8.15 Annexure: 2QA003/A15 - Format of “External training Feed Back Form” 8.16 Annexure: 2QA003/A16 - Format of “cGMP Training Annual Schedule” 8.17 Annexure: 2QA003/A17 - Format of “Curriculum Vitae” 8.18 Annexure: 2QA003/A18 - Format of “Personnel training file label” 8.19 Annexure: 2QA003/A19 - Format of Answer 8.20 Annexure: 2QA003/A20 - Format of “On Job Training Planner for month” 8.20.1 Annexure: 2QA003/A21 - Format of “Training Summary Report (On Job/ cGMP)” 8.21 Annexure: 2QA003/A22 - Format of “Trainer Resume” 8.22 Annexure: 2QA003/A23 - Addendum to List of Trainer 8.23 Annexure: 2QA003/A24 - cGMP Training module PPT format 8.24 Annexure: 2QA003/A25 - Yearly Training Schedule for Casual Workers (Housekeeping & Contract staff) END OF THE DOCUMENT 2QA001/F01-00