Pharmanovia Global Training (EQMS) SOP PDF

**Global SOP-Training (EQMS)** Table of Contents {#table-of-contents.TOCHeading} ================= [1 PURPOSE 2](#purpose) [2 SCOPE 2](#scope) [3 RESPONSIBILITIES 2](#responsibilities) [4 PROCEDURE 3](#procedure) [4.1 Training Components 3](#training-components) [4.2 Training Requirements 4](...

**Global SOP-Training (EQMS)** Table of Contents {#table-of-contents.TOCHeading} ================= [1 PURPOSE 2](#purpose) [2 SCOPE 2](#scope) [3 RESPONSIBILITIES 2](#responsibilities) [4 PROCEDURE 3](#procedure) [4.1 Training Components 3](#training-components) [4.2 Training Requirements 4](#training-requirements) [4.2.1 Onboarding Training 4](#_Toc179213388) [4.2.2 Training Needs Assessment (Role changes and new Procedures) 5](#_Toc179213389) [4.2.3 GxP and Data integrity Training Refresher 5](#_Toc179213390) [4.3 Training Matrix Maintenance 6](#training-matrix-maintenance) [5 TRAINING REQUIREMENTS 6](#training-requirements-1) [6 ABBREVIATIONS AND DEFINITIONS 6](#abbreviations-and-definitions) [7 REFERENCES 7](#references) [8 REVISION HISTORY 8](#revision-history) [9 APPENDICES 9](#appendices) [Appendix 1: Flow Chart of Training Process 10](#appendix-1-flow-chart-of-training-process) [Appendix 2: eQMS Training record search 11](#appendix-2-eqms-training-record-search) 1. PURPOSE ------- 1. This procedure defines the training process from training requirements through to training completion and record retention using EQMS. 2. SCOPE ----- 2. This SOP applies to both Internal and External training of all Pharmanovia group departments, covering the processes undertaken in the company as determined by the Roles assigned to an User. 3. The document also applies to independent contractors and other third-party suppliers assuming any of the responsibilities described in the document, unless it has been specified in contractual agreements that they will follow their own approved documents. 4. This SOP does not contain the instructions on how to create and change the Training Module configuration, course, role and reporting. These are captured in SOP082 'EQMS Training Manager (Core Skills)'. 3. RESPONSIBILITIES ---------------- +-----------------------------------+-----------------------------------+ | **Role** | **Description of | | | Responsibilities** | +===================================+===================================+ | Heads of Department | - Responsible for ensuring that | | | training is undertaken, and | | | that adequate time is | | | provided for Users in | | | relation to training. | | | | | | | | | | | | - Ensuring training compliance | | | within their department. | +-----------------------------------+-----------------------------------+ | Employee and Contractor (User) | - Complying with the | | | requirements described in | | | this document. | | | | | | - Attending, participating in, | | | and documenting completion of | | | all GxP training activities | | | prior to performance of | | | related job activities. | | | | | | - Responsible for confirming | | | own Training Records. | | | | | | - Completing required training | | | upon return to work after | | | vacation, sick leave or leave | | | of absence prior to | | | performance of related job | | | activities. | +-----------------------------------+-----------------------------------+ | Line Managers | - Ensuring personnel are | | | trained to adequately perform | | | assigned responsibilities. | | | | | | - Ensuring employees have | | | completed all their required | | | training to perform their job | | | function, and have completed | | | all required training within | | | the established timeframes. | | | | | | - Assessing the training needs | | | of employees upon their | | | return to work from vacation, | | | illness, travel, or leave of | | | absence and ensuring the | | | required training is | | | completed. | | | | | | - Must ensure employee(s) | | | undergoing training are | | | supervised / supported by an | | | assigned trained staff. | | | | | | - All Managers must assess the | | | employee training plan for | | | their staff on a yearly basis | | | on FRM029. | | | | | | | | | | | | - To ensure that new staff in | | | their department complete | | | Pharmacovigilance, Data | | | Integrity, GMP and GDP | | | training & re-current | | | assignment. | +-----------------------------------+-----------------------------------+ | EQMS Training Administrator | - Responsible to perform all | | | admin functions described in | | | SOP084. | | | | | | - Able to search and display | | | all Training Records, as well | | | as delete any records with a | | | Status that is NOT Confirmed. | | | | | | - Responsible for Role creation | | | and changes. | | | | | | - Responsible for course | | | creation. | | | | | | - Responsible for processing | | | new starter onboarding, role | | | changes and employee | | | offboarding on EQMS. | | | | | | - Responsible for Training | | | Matrix management. | | | | | | - Providing relevant training | | | reports Line Managers/HOD as | | | required. | | | | | | | | | | | | - Providing completion of | | | training metrics and training | | | issues during Management | | | Review meetings. | +-----------------------------------+-----------------------------------+ | EQMS Training Users - Department | - In addition to the EQMS | | Managers | Training User | | | responsibilities, Department | | | Managers can filter and print | | | a list of all Training | | | Records related to their | | | department. | +-----------------------------------+-----------------------------------+ | Human Resources (HR) | - Management of Job | | | Descriptions. | | | | | | | | | | | | - Raising of Solar Wind tickets | | | for New Employees/Employee | | | offboarding or Role Changes | +-----------------------------------+-----------------------------------+ | Document Owner/SME | - Determining type of training, | | | role assignment and | | | preparation of Competency | | | training, delivery and | | | recording by completing | | | FRM266 via Solar Winds. | +-----------------------------------+-----------------------------------+ | PQS Manager | - Review and approval of | | | Training Assignment (FRM266) | +-----------------------------------+-----------------------------------+ 4. PROCEDURE --------- 5. Training Components ------------------- - **Training Role**; an eqms role that contains a series of courses assigned. Each User is assigned to a Role(s). - **Training Course**; a training component within the eqms system that may contain an approved document (e.g. SOP or POL document) or be a placeholder for a planned or a record of an executed training (e.g. External Auditor course). - **Training Matrix**. The eQMS provides a 'Training Matrix' report that contains a list of Courses and Users, that can be queried by Role. The training status is then shown within (legend explained in SOP084). - **Training Plan**. User training obtained via the training matrix. - **Training Quiz**. A series of Questions issued to User to assess competency. The default pass mark is set to 80% success and set to three attempts, if unsuccessful the Quiz will be required to be re-set by EQMS Training Administrator after consultation with Document Owner. - **Training Types and records.** There are 4 types of training, as follows: - [Instructional/Self-train]: Document (Policy/SOP) training records can be completed in one of 2 ways depending on the training needs. The Document Owner/SME is responsible to determine if the Training Record is to have a questionnaire or a 'Read and Understood' confirmation under a Quiz (FRM266). - [Competency/Instructor Led]: Training is completed for activities requiring practical application to qualifying learners in a one-on-one or small group event e.g. performing batch reviews, auditing etc. - [Group briefing]: this involves completing the training in a meeting-type session. This ad hoc training can be documented in FRM132 'Class Sign in Sheet'. - [External training]: when an external quality training is attended through an external vendor. A certificate is provided that verifies attendance and completion. +-----------------------+-----------------------+-----------------------+ | **Document** | **Type of training** | **Method to Record | | | | Training Completion** | +=======================+=======================+=======================+ | POL/SOP | Self Train | Trainee signs for | | | | completion in eQMS | +-----------------------+-----------------------+-----------------------+ | FRM053 | Instructor Led | Document Owner/SME | | | | forward FRM053 to | | | | EQMS Training | | | | Administrator who | | | | creates a Training | | | | Course in Eqms. | | | | | | | | Trainee to complete | | | | Eqms training record. | +-----------------------+-----------------------+-----------------------+ | FRM132 | Group briefing | Participants sing | | | session | FRM132 that will be | | | | attached into | | | | Deviation eQMS record | +-----------------------+-----------------------+-----------------------+ | External Certificate | External provider | Trainee sends | | | | Training certificate | | | | to EQMS Training | | | | Administrator who | | | | creates a Training | | | | Course in Eqms. | | | | | | | | Trainee to complete | | | | Eqms training record. | +-----------------------+-----------------------+-----------------------+ Training Requirements --------------------- []{#_Toc179213388.anchor}4.2.1 Onboarding Training +-----------------------+-----------------------+-----------------------+ | **4.2.1** | **Responsible Role** | **Action Step** | +=======================+=======================+=======================+ | **4.2.1.1** | **EQMS Training | Upon receipt of an | | | Administrator** | Employee on-boarding | | | | requests from Solar | | | | Winds, assign the | | | | following procedures | | | | (at a minimum) to all | | | | new staff as part of | | | | induction: | | | | | | | | Training | | | | | | | | Pharmacovigilance | | | | | | | | GMP | | | | | | | | GDP | | | | | | | | Data Integrity | +-----------------------+-----------------------+-----------------------+ | **4.2.1.2** | **Line Manager** | Identify the Eqms | | | | Role required and | | | | communicates this to | | | | the EQMS Training | | | | Administrator. | +-----------------------+-----------------------+-----------------------+ | **4.2.1.3** | **EQMS Training | Assign the Role | | | Administrator** | training to new | | | | Employee as | | | | instructed by Line | | | | Manager. | +-----------------------+-----------------------+-----------------------+ | **4.2.1.4** | **EQMS Training | Sign off the Solar | | | Administrator** | Winds assigned | | | | training task. | +-----------------------+-----------------------+-----------------------+ | **4.2.1.5** | **User** | Completion of | | | | assigned training | | | | during the training | | | | window (30 days for | | | | new starters and 10 | | | | days for new and | | | | updated procedures). | | | | | | | | If training queries | | | | reach out to EQMS | | | | Training | | | | Administrator via | | | | Solar Winds platform. | | | | | | | | If training record | | | | exceeds the training | | | | due date a reminder | | | | e-mail is sent by the | | | | eqms to the trainee | | | | at seven day | | | | intervals. | +-----------------------+-----------------------+-----------------------+ []{#_Toc179213389.anchor}4.2.2 Training Needs Assessment (Role changes and new Procedures) **4.2.2** **Responsible Role** **Action Step** ------------- --------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ **4.2.2.1** **EQMS Training Administrator** Upon receipt of an Employee mover/change request from Solar Winds contact the Line Manager requestor. **4.2.2.2** **Line Manager** Identify the Role and any Course(s) required, complete FRM266 and communicates this to the PQS Manager. **4.2.2.3** **PQS Manager** Reviews FRM266 and approves as required, forwards approved FRM266 to EQMS Training Administrator via Solar Winds. **4.2.2.4** **EQMS Training Administrator** Assign the Role and Course(s) training as documented in FRM266. **4.2.2.5** **Document Owner** Identify the assignment to Role(s) required for a new document and provides the associated training type to the EQMS Training Administrator, this request is documented in FRM266. **4.2.2.6** **PQS Manager** Reviews FRM266 and approves as required, forwards approved FRM266 to EQMS Training Administrator. **4.2.2.7** **EQMS Training Administrator** Assign the Role and Course(s) training as documented in FRM266. []{#_Toc179213390.anchor}4.2.3 GxP and Data integrity Training Refresher **4.2.3** **Responsible Role** **Action Step** ------------- --------------------------------- ------------------------------------------------------------------------------------------------------------------------------------- **4.2.3.1** **EQMS Training Administrator** On an annual basis issue, the PV (SOP107), GDP and GMP (Basic and non-basic), Data integrity (POL001) courses to all staff members. 4.2.4 Training after an Absence **4.2.4** **Responsible Role** **Action Step** ------------- ---------------------- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- **4.2.4.1** **Line Manager** Ensure that employees who have been on vacation, out of the office due to illness or on leave of absence complete missed training upon their return to work and prior to performing tasks supported by the training. **4.2.4.2** **Line Manager** When the leave of absence is planned, request pause of the employee as per SOP023. **4.2.4.3** **Line Manager** Assess if competency sessions are required depending on the length of leave and any significant changes occurring during the absence. 4.2.5 Training Offboarding **4.2.5** **Responsible Role** **Action Step** ------------- --------------------------------- -------------------------------------------------------------------------- **4.2.5.1** **User** Ensure no outstanding training prior to leaving the organization. **4.2.5.2** **EQMS Training Administrator** Receives the task of employee offboarding as per SOP023 and executes it. 4.3 Training Matrix Maintenance ------------------------------- +-----------------------+-----------------------+-----------------------+ | **4.3** | **Responsible Role** | **Action Step** | +=======================+=======================+=======================+ | **4.3.1** | **EQMS Training | Maintains and manages | | | Administrator** | changes to the Eqms | | | | Training module as | | | | described in SOP08.4 | +-----------------------+-----------------------+-----------------------+ | **4.3.2** | **EQMS Training | On an annual basis | | | Administrator** | coordinates the | | | | periodic review of | | | | the training Matrix | | | | by reaching out to | | | | the relevant Line | | | | manager providing the | | | | following | | | | information: | | | | | | | | - List of Courses | | | | assigned to the | | | | Role | | | | | | | | - List of all | | | | existing Courses | +-----------------------+-----------------------+-----------------------+ | **4.3.3** | **Line manager** | Completes FRM029 | | | | indicating: | | | | | | | | - Removal of | | | | Courses (if | | | | required) | | | | | | | | - Addition of | | | | Courses (if | | | | required) | +-----------------------+-----------------------+-----------------------+ | **4.3.4** | **EQMS Training | Change the Roles | | | Administrator** | based on completed | | | | FRM029 and assigns | | | | new training for new | | | | courses and cancels | | | | any assigned training | | | | for cancelled | | | | courses. | +-----------------------+-----------------------+-----------------------+ 5. TRAINING REQUIREMENTS --------------------- 7. Any personnel new to this document must complete a questionnaire and read and understood declaration in EQMS Training Manager. 8. Personnel already trained to this document must retrain and submit a questionnaire and read and understood declaration in EQMS Training Manager. 6. ABBREVIATIONS AND DEFINITIONS ----------------------------- 6.1 The following is a list of abbreviations used in this document: **Term** **Meaning** ---------- -------------------------------------------------------------------------------------------------------- EQMS Electronic Quality Management System GxP Withing this procedures refers to Good Manufacturing, Good Pharmacovigilance and Distribution Practice SOP Standard Operating Procedure 6.2 The following is a list of definitions and technical terms used in this document: +-----------------------------------+-----------------------------------+ | **Term** | **Definition** | +===================================+===================================+ | Competency Training | This phase relates to when staff | | | must to demonstrate competency as | | | per Training Plan. | +-----------------------------------+-----------------------------------+ | Contractor | A non-employee with whom | | | Pharmanovia Group contracts to | | | perform a service | +-----------------------------------+-----------------------------------+ | Course | A training course contains the | | | title, version, category, | | | frequency, documents (if | | | appliable), quiz and Roles and ad | | | hoc Users required to complete | | | the course. | +-----------------------------------+-----------------------------------+ | Document Owner/Subject Matter | People with a high level of | | Expert (SME) | expertise and experience to | | | perform a specialised job, task, | | | or skill. | +-----------------------------------+-----------------------------------+ | Eqms Training Administrator | Staff who update the Training | | | Module to enable training record | | | creation for relevant staff. | +-----------------------------------+-----------------------------------+ | Pharmanovia Group | Group of Companies either | | | operating under an MIA or WDA or | | | an affiliate of these named | | | entities. As defined by the | | | Pharmanovia Corporate structure | +-----------------------------------+-----------------------------------+ | Returning Staff | Staff who return to Pharmanovia | | | Group after leaving the company | | | or current staff on long term | | | absence | +-----------------------------------+-----------------------------------+ | Training Role | A role contains a series of | | | courses assigned. Each User is | | | assigned to a Role(s) | +-----------------------------------+-----------------------------------+ | Training Matrix | A representation of training | | | requirements approved by | | | Management for all staff and what | | | has been completed or not using a | | | colour coding system. The | | | training matrix contains the | | | minimum required training to | | | perform a Role. | | | | | | Only accessible with certain user | | | permissions. | +-----------------------------------+-----------------------------------+ | Training Pass Mark | The minimum mark required to | | | achieve a pass when completing a | | | quiz. | +-----------------------------------+-----------------------------------+ | Training Window | Period to complete training from | | | date of training (document) issue | | | by the Training Administrator | +-----------------------------------+-----------------------------------+ | Training Records | A collection of documents used to | | | record training. | +-----------------------------------+-----------------------------------+ | Training Records List | The filterable list of a user's | | | training records. | +-----------------------------------+-----------------------------------+ 7. REFERENCES ---------- 9. The following is a list of references used in this document. All associated SOPs, Forms and Policies can be found on EQMS: **ID** **Title** -------- --------------------------------------------------------------------- POL001 Global Data Integrity Policy SOP084 Global EQMS Training Manager (Core Skills) SOP107 Global Reporting of Potential Adverse Events and safety information FRM029 Training Effectiveness Assessment FRM053 Competency Training Record FRM132 Class Sign In Sheet FRM266 Global Training Assignment REVISION HISTORY ---------------- +-----------------------+-----------------------+-----------------------+ | **Version** | **Category** | **Summary of | | | | Changes** | +=======================+=======================+=======================+ | 5 | A | Content transfer to | | | | current FRM015 | | | | template. | | | | | | | | SMF training removed | | | | from Induction | | | | training as no longer | | | | part of Induction | | | | training Role | | | | assignment. | | | | | | | | Removal of FRM151 as | | | | it is captured within | | | | related SOP023 and | | | | thus duplicated in | | | | this procedure. | | | | | | | | Addition of new | | | | FRM266 to document | | | | training needs | | | | assignment. | | | | | | | | Removal of Job | | | | description section | | | | as included in | | | | SOP023. | | | | | | | | Training role, | | | | training plan, | | | | training type and | | | | records' section | | | | content clubbed under | | | | a new Training | | | | components section. | | | | | | | | Training record | | | | search transferred | | | | into a new appendix 2 | | | | section. | | | | | | | | Step 4.3.2 added | | | | following DEV3227. | | | | | | | | Removal of references | | | | to SOP038 (ref to | | | | CC3041), SOP077, | | | | POL010 and addition | | | | of SOP107 and POL001 | +-----------------------+-----------------------+-----------------------+ | 4 | A | Full rewrite of | | | | procedure following | | | | CC1741 Training Gap | | | | assessment. | | | | | | | | Changes are: | | | | | | | | Definitions | | | | | | | | Responsibilities | | | | | | | | Inclusion of New | | | | starters training | | | | | | | | Inclusion of Annual | | | | training | | | | | | | | Type of training and | | | | record of training | | | | | | | | Training matrix | | | | description as well | | | | as Role | | | | | | | | Training management | | | | during leave/absence | | | | | | | | Obsoletion/retirement | | | | of FRM054 as not used | | | | | | | | Updates as per CAPA | | | | 2117 also captured. | | | | | | | | Section 4.6.4 added | | | | to document overdue | | | | training records | | | | | | | | Reference to CAPA701 | | | | in v3.0 revision | | | | history | | | | | | | | EQMS Training | | | | Administrators role | | | | removed | | | | | | | | Reference to POL002 | | | | | | | | Reference to FRM132 | +-----------------------+-----------------------+-----------------------+ | 3 | A | Update to section | | | | 4.4. Template update | | | | in line with Atnahs | | | | Document Template. | | | | Definition of course | | | | explained. | | | | Re-training required. | | | | | | | | Update as per CAPA | | | | 701 included. | +-----------------------+-----------------------+-----------------------+ | 2 | A | Training process | | | | changed in line with | | | | implementation of | | | | EQMS Training | | | | Manager. Re-training | | | | required. | +-----------------------+-----------------------+-----------------------+ | 1 | C | First version | | | | transferred from | | | | QUA-SOP-001 v3 | +-----------------------+-----------------------+-----------------------+ APPENDICES ---------- **Number** **Title** ------------ -------------------------------- 1 Flow Chart of Training Process 2 eQMS Training record search Appendix 1: Flow Chart of Training Process ------------------------------------------ Legend: Appendix 2: eQMS Training record search --------------------------------------- Searches can be done by navigating to Training Manager and clicking on Training Records - - - Graphical user interface, application Description automatically generated - - -