Strengthen Your Role in Collaboration with QA, Operations and Management
As a support professional, employees need to be able to act professionally and apply their professional expertise – even in challenging situations.
About the course
Read about the benefits of a company course
Starting out as an academic professional in the life science industry can feel like entering a complex system with many stakeholders, requirements and decisions. This course helps new employees understand the environment they are part of.
We explore how the organisation surrounding production, quality and regulatory authorities is structured and interconnected. You will gain practical tools to strengthen your role as a professional sparring partner and link between Operations, Management, subject-matter experts and QA, and learn how to communicate professionally with different professional groups.
We introduce some of the terms and abbreviations employees encounter in their everyday work, such as MAH, APS, product quality, patient safety and compliance.
Legislation describes principles and objectives rather than always providing specific solutions. The course therefore gives you a more realistic understanding of the dilemmas, grey areas and interpretation of requirements that employees encounter in everyday work – and trains you to handle them professionally and based on sound professional judgement.
We also cover inspection readiness and how support professionals can contribute before, during and after an inspection.
We discuss when the level of documentation in areas such as deviations is sufficient.
Through presentations, case studies, exercises and dialogue, we work with both theory and practical situations, so that you leave the course with greater confidence in your professional judgement and your role as a link between different functions in everyday work.
Starting out as an academic professional in the life science industry can feel like entering a complex system with many stakeholders, requirements and decisions. This course helps new employees understand the environment they are part of.
We explore how the organisation surrounding production, quality and regulatory authorities is structured and interconnected. You will gain practical tools to strengthen your role as a professional sparring partner and link between Operations, Management, subject-matter experts and QA, and learn how to communicate professionally with different professional groups.
We introduce some of the terms and abbreviations employees encounter in their everyday work, such as MAH, APS, product quality, patient safety and compliance.
Legislation describes principles and objectives rather than always providing specific solutions. The course therefore gives you a more realistic understanding of the dilemmas, grey areas and interpretation of requirements that employees encounter in everyday work – and trains you to handle them professionally and based on sound professional judgement.
We also cover inspection readiness and how support professionals can contribute before, during and after an inspection.
We discuss when the level of documentation in areas such as deviations is sufficient.
Through presentations, case studies, exercises and dialogue, we work with both theory and practical situations, so that you leave the course with greater confidence in your professional judgement and your role as a link between different functions in everyday work.
Target group
New academics in the life science industry, such as support professionals, EM support staff, coordinators and others working in support functions related to production and quality.
Why choose this course
Benefits for employees
- You gain an understanding of the bigger picture and your own role within the life science industry.
- You can handle grey areas in GMP with greater confidence.
- You can communicate professionally with Operations, QA, subject-matter experts and Management.
Benefits for the organisation
- Employees become independent in their roles more quickly.
- Employees make more confident and well-founded decisions.
- Employees are better equipped for cross-functional collaboration.
Course programme
- Overall Perspective
- The Role as a link
- Good Documentation
- Interpretation of Requirements
- Navigating the Grey Areas
Register for the course
Course The Effective Support Professionel|company
Format 1 day in-company
Price 45.300 kr. excl. VAT
Choose a date and sign up
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