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  • Cognicert - ISO 20387 Bio Banking Lead Implementer Course

The Cognicert ISO 20387 Bio Banking Lead Implementer Course equips professionals with the knowledge to implement ISO 20387 standards in biobanks. It focuses on establishing effective management systems for the quality, storage, and traceability of biological materials in biobanks.

Instructor

Cognicert ISO 20387 Biobanking Lead Implementer Course | Implement Biobanking Management Systems

Curriculum

Gain expertise in implementing biobanking management systems according to ISO 20387 standards. Learn how to manage biological material quality and traceability in biobanks.

Ratings

( 4.3 Ratings )

Live Online Classes starting on 01 January, 1970

Cognicert - ISO 20387 Bio Banking Lead Implementer Course

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.

 

Target Audience:

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.

 

Reference Standards:

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.

 

Objectives:

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.

 

Training Methodologies

  •  Case Study

  •  Individual Exercises

  •  Role Play

  •  Group Exercises

  •  Group Presentation

  •  Examination

 

Course Outline

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

(4.3 Ratings)

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