R-005-003 Training plan 2024
Training matrix for onboarding
General
| JD-001 | JD-002 | JD-003 | JD-004 | JD-005 | JD-006 | JD-007 | JD-008 | JD-009 | JD-010 | JD-011 | JD-012 | JD-013 | JD-014 | JD-016 | JD-017 | JD-018 | JD-019 | JD-021 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Prevention of risk at work | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| GDPR | Trainee | Trainee | 👩🏫 | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| Cybersecurity | Trainee | Trainee | 👩🏫 | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| Good clinical practice | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | 👩🏫 | ||||||||||||
| QMS | Trainee | Trainee | 👩🏫 | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
Legend
The symbols in the table mean:
- 👩🏫: Trainer
QMS procedures
| JD-001 | JD-002 | JD-003 | JD-004 | JD-005 | JD-006 | JD-007 | JD-008 | JD-009 | JD-010 | JD-011 | JD-012 | JD-013 | JD-014 | JD-016 | JD-017 | JD-018 | JD-019 | JD-021 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GP-001 Documents and records control | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | ||
| SP-001-001 eIFU management | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||||
| GP-002 Quality planning | Trainee | Trainee | Trainee | Trainee | |||||||||||||||
| GP-003 Audits | Trainee | Trainee | Trainee | Trainee | |||||||||||||||
| GP-004 Vigilance system | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| SP-004-001 Product Withdrawal | Trainee | Trainee | Trainee | ||||||||||||||||
| GP-005 Human resources and training | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| SP-005-001 Anti-corruption and anti-bribery | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| GP-006 Non-conformity, Corrective and preventive actions | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| GP-007 Post-market surveillance | Trainee | Trainee | Trainee | Trainee | |||||||||||||||
| GP-008 Product requirements | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | ||||||||||||
| GP-009 Sales | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||
| SP-009-001 How to use CRM | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||
| SP-009-002 How to use contracts | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | ||||||||||
| SP-009-003 How to share performance metrics | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | ||||||||
| GP-010 Purchases and suppliers evaluation | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||||||||
| GP-011 Provision of service | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | ||||||
| GP-012 Design, re-design and development | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||||||
| SP-012-002 Cybersecurity and transparency requirements | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||||||||
| GP-013 Risk management | Trainee | Trainee | Trainee | ||||||||||||||||
| GP-014 Feedback and complaints | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||
| GP-015 Clinical evaluation | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||||||||
| GP-016 Traceability and identification | Trainee | Trainee | Trainee | Trainee | Trainee | ||||||||||||||
| GP-017 Technical Assistance Service | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||||||||
| GP-018 Infrastructure and facilities | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | ||||||||||||
| SP-018-001 Remote infrastructure control access policy | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||||||||
| GP-019 Software validation | Trainee | Trainee | Trainee | ||||||||||||||||
| GP-020 QMS Data analysis | Trainee | Trainee | Trainee | Trainee | |||||||||||||||
| GP-021 Communications | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |
| GP-022 Document translation | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | ||||||||||||
| GP-023 Change control management | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | ||||
| GP-050 Data protection | Trainee | Trainee | Trainee | Trainee | Trainee | ||||||||||||||
| SP-050-001 Data protection officer manual | Trainee | Trainee | Trainee | Trainee | Trainee | ||||||||||||||
| SP-050-002 Manual of functions and obligations of the staff | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| GP-051 Security violations | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||||||||
| GP-052 Data Privacy Impact Assesment (DPIA) | Trainee | Trainee | Trainee | Trainee | Trainee | ||||||||||||||
| GP-100 Business continuity and disaster recovery plans | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | |||||||||||||
| GP-101 Information security | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
Training plan for the year 2024
| Date | Trainee | Title of the training | Trainer | Planified on | Approved by JD-001? | Estimated duration (h) | Training objective | Evaluation by the JD-001 General Manager | Comments |
|---|---|---|---|---|---|---|---|---|---|
| 20230901 | Alba Santacreu | Executive HR Agile | Stellium Business School | 20240206 | Yes | 45 | Streamlining human resources processes and tools for fostering remote culture | ||
| 20240102 | Luiza Fernandes | Prevention of risk at work | Prevenlabur | 20240120 | Yes | 2 | Prevent risk at work | ||
| 20240102 | Isamara Machado Antunes | Prevention of risk at work | Prevenlabur | 20240120 | Yes | 2 | Prevent risk at work | ||
| 20240102 | Giulia Foglia | Prevention of risk at work | Prevenlabur | 20240210 | Yes | 2 | Prevent risk at work | ||
| 20240403 | Josefa Mateo | Prevention of risk at work | Prevenlabur | 20240410 | Yes | 2 | Prevent risk at work | ||
| 20240506 | Alba Rodriguez | Prevention of risk at work | Prevenlabur | 20240515 | Yes | 2 | Prevent risk at work | ||
| 20240506 | Valeria Vargas | Prevention of risk at work | Prevenlabur | 20240515 | Yes | 2 | Prevent risk at work | ||
| 20240603 | Jorge Juan Alaman | Prevention of risk at work | Prevenlabur | 20240620 | Yes | 2 | Prevent risk at work | ||
| 20240603 | Victor Gisbert | Prevention of risk at work | Prevenlabur | 20240620 | Yes | 2 | Prevent risk at work | ||
| 20240617 | David Sánchez | Prevention of risk at work | Prevenlabur | 20240701 | Yes | 2 | Prevent risk at work | ||
| 20240711 | Constanza Majdalani | Prevention of risk at work | Prevenlabur | 20240725 | Yes | 2 | Prevent risk at work | ||
| 20240826 | Maria Ribagorda | Prevention of risk at work | Prevenlabur | 20240909 | Yes | 2 | Prevent risk at work | ||
| 20240909 | Nathalie Elodie Esteves | Prevention of risk at work | Prevenlabur | 20240916 | Yes | 2 | Prevent risk at work | ||
| 20240916 | Irene González | Prevention of risk at work | Prevenlabur | 20240923 | Yes | 2 | Prevent risk at work | ||
| 20240923 | Jon Roca | Prevention of risk at work | Prevenlabur | 20241002 | Yes | 2 | Prevent risk at work | ||
| 20241016 | Loreto Gómez | Prevention of risk at work | Prevenlabur | 20241104 | Yes | 2 | Prevent risk at work | ||
| 20241118 | Idoia Garro | Prevention of risk at work | Prevenlabur | 20241125 | Yes | 2 | Prevent risk at work | ||
| 20241125 | Agustín Oyhamburu | Prevention of risk at work | Prevenlabur | 20241203 | Yes | 2 | Prevent risk at work | ||
| 20240102 | Alazne Echevarria | Practical accounting | CEF | 20240210 | Yes | 90 | Advanced accounting practices | ||
| 20240102 | Andy Aguilar | Data privacy | Audens Legal SLP | 20240517 | Yes | 4 | Understand the GDPR | ||
| 20240102 | Alfonso Medela | Data privacy | Audens Legal SLP | 20240517 | Yes | 3 | Understand the GDPR | ||
| 20240102 | Taig Mac Carthy | Data privacy | Audens Legal SLP | 20240517 | Yes | 4 | Understand the GDPR | ||
| 20240102 | Gerardo Fernández | Data privacy | Audens Legal SLP | 20240517 | Yes | 3 | Understand the GDPR | ||
| 20240102 | Sara Recalde | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | ||
| 20240102 | Ignacio Hernández | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | ||
| 20240102 | Alazne Echevarria | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | ||
| 20240102 | Alejandro Carmena | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | ||
| 20240102 | Pau Ros | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | ||
| 20240102 | Alba Santacreu | Data privacy | Audens Legal SLP | 20240517 | Yes | 3 | Understand the GDPR | ||
| 20240102 | Alberto Sabater | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | ||
| 20240102 | Daniel Dagnino | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | ||
| 20240102 | Arantxa Cuello | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | The employee left the company before the training | |
| 20240102 | Jordi Barrachina | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | ||
| 20240102 | Luiza Fernandes | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | The employee left the company before the training | |
| 20240102 | Isamara Machado Antunes | Data privacy | Audens Legal SLP | 20240517 | Yes | 3 | Understand the GDPR | ||
| 20240102 | Giulia Foglia | Data privacy | Audens Legal SLP | 20240517 | Yes | 3 | Understand the GDPR | ||
| 20240102 | Josefa Mateo | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | ||
| 20240102 | Alba Rodriguez | Data privacy | Audens Legal SLP | 20240517 | Yes | 4 | Understand the GDPR | ||
| 20240102 | Valeria Vargas | Data privacy | Audens Legal SLP | 20240517 | Yes | 2 | Understand the GDPR | ||
| 20240402 | Giulia Foglia | Cybersecurity workshop | Dmed-software | 20240904 | Yes | 16 | Understand the improvements on current cibersecurity documentation | ||
| 20240402 | Alberto Sabater | Cybersecurity workshop | Dmed-software | 20240904 | Yes | 16 | Understand the improvements on current cibersecurity documentation | ||
| 20240402 | Alejandro Carmena | Cybersecurity workshop | Dmed-software | 20240904 | Yes | 16 | Understand the improvements on current cibersecurity documentation | ||
| 20240402 | Daniel Dagnino | Cybersecurity workshop | Dmed-software | 20240904 | Yes | 16 | Understand the improvements on current cibersecurity documentation | ||
| 20240402 | Gerardo Fernández | Cybersecurity workshop | Dmed-software | 20240904 | Yes | 16 | Understand the improvements on current cibersecurity documentation | ||
| 20240402 | Victor Gisbert | Cybersecurity workshop | Dmed-software | 20240904 | Yes | 16 | Understand the improvements on current cibersecurity documentation | ||
| 20240402 | Alfonso Medela | Cybersecurity workshop | Dmed-software | 20240904 | Yes | 16 | Understand the improvements on current cibersecurity documentation | ||
| 20240402 | Ignacio Hernández | Cybersecurity workshop | Dmed-software | 20240904 | Yes | 16 | Understand the improvements on current cibersecurity documentation | ||
| 20240402 | Taig Mac Carthy | Cybersecurity workshop | Dmed-software | 20240904 | Yes | 16 | Understand the improvements on current cibersecurity documentation |
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001