Training Objectives
By the end of this course, participants will:
- Understand the purpose and scope of ISO 20387:2018
- Become familiar with key biobanking concepts and terminology
- Gain awareness of the main requirements of the standard
- Understand the importance of quality, competence, and impartiality
- Recognize how ISO 20387 applies to biobank operations
Learning Outcomes
Participants will be able to:
- Explain what ISO 20387 is and why it is important
- Identify the main clauses and structure of the standard
- Describe key requirements at a high level
- Recognize the role of quality management in biobanking
- Support basic awareness and compliance discussions in their organization
Target Audience
- Biobank and laboratory staff
- Researchers and healthcare professionals
- Quality and compliance personnel
- New staff in biobanking environments
- Anyone needing basic knowledge of ISO 20387
Course Content
Introduction to Biobanking & ISO 20387
- What is a biobank?
- Importance in research and healthcare
- Overview of ISO 20387 and its benefits
Key Concepts and Terminology (45 mins)
- Biological materials and data
- Types of biobanks
- Key stakeholders
Overview of ISO 20387 Structure
- High-level structure
- Summary of key clauses:
- General requirements
- Resources
- Processes
- Management system
Core Requirements (High-Level)
- Competence and personnel
- Facilities and equipment
- Sample handling and traceability
- Data management and confidentiality
- Impartiality
Management System Awareness
- Documentation basics
- Risk-based thinking
- Internal audits and improvement
- Importance of consistency and quality
Ethics and Practical Insights
- Ethical considerations
- Data protection
- Common challenges in biobanking
Wrap-Up & Discussion
- Key takeaways
- Q&A
- Short quiz or recap
Training Methodology
- Short lectures
- Practical examples
- Group discussion
- Quick knowledge checks
Duration
- 1 Day
