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Understanding ISO/IEC 20387:2018 General Requirements for Biobanking

This two-day workshop covers the understanding and implementation of a quality management system for biobanking organizations which collect, receive, transport, distribute, prepare, preserve, and store biological material, microorganisms, and genomic data. It is designed to help the participant understand its roles and responsibilities in concert with the requirements of ISO 20387 and to ensure the goals of biorepository functions are consistently and confidently achieved. Participants will be introduced to risk-based thinking concepts and quality management system principles to guide the improvement and harmonization of its processes. Instructors will lecture to establish fundamental concepts and requirements, lead exercises and discussions to illustrate and affirm concepts, and provide opportunities for learning best practices through peer-to-peer discussions. This course does not focus on unique applications of the various types of biobanks but does cover generic philosophies and applications suitable for all types.

Price: $1450.00

Prerequisites

There are no prerequisites for this training. However, participants would benefit from having work experience in a biobank repository with a broad understanding of all aspects of the biobanking process. It is strongly encouraged to read ISO 20387 and to formulate specific questions about it or its application in your organization prior to attending the class. This will enrich your and your fellow participants’ experience in the workshop.

Equipment Needed

Laptop computer (PC or MAC) or tablet.

Target Attendees

This workshop is intended for management, technical, and quality audiences whose responsibilities include managing bio-banked materials or data. These occupations may include but are not limited to:

  • Researchers
  • Scientists
  • Quality Assurance Managers
  • Senior Technicians

Learning Outcomes

After the successful completion of the workshop, participants will be able to:

  1. Discuss and describe key quality management system components and how they shape an effective biobanking program
  2. Define and illustrate key control mechanisms that ensure suitability of biological materials, microorganisms, and data are suitable for distribution when needed.
  3. Outline the process and illustrate the material handling life cycle while identifying key risk areas that might threaten a successful biobanking program
  4. Discuss potential mitigation strategies for the risks identified above that can be implemented in the management system
  5. Describe the key threats to ethical and regulatory compliance and discuss mitigation strategies
  6. Using provided scenarios and course materials, perform a mini desk audit to determine conformance to the ISO 20387 standard

CEUs Awarded

1.4 CEUs Awarded*

* A2LA WorkPlace Training is accredited by the International Association for Continuing Education and Training (IACET) and is authorized to issue the IACET CEU.

Presentation Style

Lectures, discussions, and classroom exercises. An exam is available upon request.

Reference

This course follows the principles outlined in the following documents:

  • ISO 20387:2018, Biotechnology — Biobanking — General requirements for biobanking
  • ISO 8601:2019 Series, Data elements and interchange formats — Information interchange — Representation of dates and times

Students are required to bring copies with them furnished by their company or purchase them directly from ISO or other approved document provider prior to the class. A controlled ISO 20387 training checklist will be supplied to all participants after registration.

Training Dates

August 12 – 13, 2025
Virtual Class
8am - 5pm EST

Register