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The “ISO 20387 Lead Implementer Course” is designed to equip individuals with the knowledge and skills needed to plan, implement, and manage a biobanking system in accordance with ISO 20387:2018. This course focuses on the specific requirements of ISO 20387 and provides practical guidance on establishing and maintaining a compliant biobanking system. Participants will gain the expertise to lead the implementation of ISO 20387 in biotechnology laboratories and organizations.
The target audience for the “ISO 20387 Lead Implementer Course” includes:
- Biotechnology Professionals: Professionals working in the biotechnology sector responsible for implementing ISO 20387 in their organizations.
- Laboratory Managers: Laboratory managers and supervisors in biotechnology facilities seeking to implement ISO 20387.
- Quality Assurance Specialists: Quality assurance professionals involved in establishing and managing biobanking systems.
- Biobank Administrators: Individuals responsible for the day-to-day operation and compliance of biobanks.
The primary reference standard for this course is ISO 20387:2018 – “Biotechnology – Biobanking – General Requirements for Biobanking.” In addition, the training may reference ISO 9001:2015 – “Quality Management Systems” as a general framework for quality management principles and practices.
The objectives of the “ISO 20387 Lead Implementer Course” are:
- Understanding ISO 20387: To provide participants with a comprehensive understanding of the ISO 20387 standard and its significance in biotechnology laboratories and biobanking.
- Implementation Principles: To familiarize participants with the principles of implementing ISO 20387 effectively.
- Lead Implementer Competencies: To develop the competencies required to lead the implementation of ISO 20387 in biotechnology laboratories and organizations.
- Biobanking Best Practices: To equip participants with knowledge of best practices for establishing and managing biobanks in compliance with ISO 20387.
By the end of the course, participants should be able to:
- Interpret and apply the requirements of ISO 20387:2018 to establish and manage a biobanking system.
- Plan and execute the implementation of ISO 20387 in their biotechnology laboratory or organization.
- Establish policies, procedures, and documentation to support compliance with ISO 20387.
- Ensure the effective management of biobanking activities and continuous improvement of the system.
- Demonstrate the skills and knowledge necessary to lead the implementation of ISO 20387 in their biotechnology setting.
The training content should cover various aspects of ISO 20387 implementation. Here’s a breakdown of potential content areas:
Module 1: Introduction to ISO 20387
- Overview of ISO 20387:2018 and its scope
- The importance of ISO 20387 in biotechnology biobanking
Module 2: Principles of ISO 20387 Implementation
- Key principles and concepts of ISO 20387 implementation
- Understanding the Plan-Do-Check-Act (PDCA) cycle
Module 3: ISO 20387 Requirements
- In-depth examination of ISO 20387 requirements
- Interpretation and application of ISO 20387 clauses
Module 4: Implementation Planning
- Developing an implementation plan and strategy
- Allocating resources and responsibilities
Module 5: Documentation and Policies
- Developing policies and procedures to support ISO 20387 compliance
- Document control and record-keeping requirements
Module 6: Risk Assessment and Mitigation
- Conducting a risk assessment in the context of biobanking
- Strategies for risk mitigation and management
Module 7: Biobank Infrastructure and Equipment
- Requirements for biobank facilities, storage, and equipment
- Ensuring compliance with infrastructure requirements
Module 8: Personnel and Training
- Staff competencies and training requirements
- Strategies for maintaining a skilled workforce
Module 9: Biobank Operations
- Managing day-to-day biobanking activities in compliance with ISO 20387
- Ensuring the traceability and integrity of collected samples
Module 10: Auditing and Internal Assessment
- Preparing for internal audits and self-assessments
- Best practices for conducting internal assessments
Module 11: Continual Improvement
- The role of continual improvement in ISO 20387 implementation
- Collecting and analyzing data for performance improvement
Module 12: Leading the Implementation Team
- Leading and managing the implementation team effectively
- Team dynamics, communication, and collaboration
Module 13: Certification and Compliance
- Preparing for ISO 20387 certification and audits
- Demonstrating compliance with ISO 20387 requirements
Duration: 5 days
- Case Study
- Individual Exercises
- Role Play
- Group Exercises
- Group Presentation