Cognicert ISO 20387 Bio-banking Management System Lead Assessor Course

Training Overview:

The “ISO 20387 Lead Assessor Course” is a comprehensive program designed to equip individuals with the knowledge and skills needed to assess and evaluate biobanking systems in accordance with ISO 20387:2018. This course focuses on the principles of assessment, audit methodologies, and the specific requirements of ISO 20387. Participants will learn how to lead and conduct assessments of biobanking facilities and organizations to ensure compliance with the standard.

Target Audience:

The target audience for the “ISO 20387 Lead Assessor Course” includes professionals and individuals who wish to become proficient in leading assessments and audits of biobanking systems. This may include:

Quality Assurance Professionals: Quality assurance managers, specialists, and professionals responsible for assessing and ensuring compliance with ISO 20387 in biobanking facilities.
Biobank Managers: Managers and administrators of biobanking facilities seeking to assess and improve their compliance with ISO 20387.
Biotechnology Industry Professionals: Professionals working in the biotechnology sector interested in conducting assessments and audits of biobanks.
Experienced Auditors: Individuals with prior experience in auditing quality management systems who wish to expand their auditing expertise to include biobanking.

Reference Standards:

The primary reference standard for this course is ISO 20387:2018 – “Biotechnology – Biobanking – General Requirements for Biobanking.” Additionally, the course may reference ISO 19011:2018 – “Guidelines for Auditing Management Systems” to provide a framework for audit practices and principles.

Objectives:

The objectives of the “ISO 20387 Lead Assessor Course” are:

Understanding ISO 20387: To provide participants with a comprehensive understanding of the ISO 20387 standard and its relevance to biobanking.
Assessment Principles: To familiarize participants with the principles of assessment, audit planning, and audit methodologies specific to biobanking.
Lead Assessor Competencies: To develop the competencies required to lead assessments and audits of biobanking facilities effectively.
Biobank Assessment Practices: To equip participants with knowledge of best practices for assessing and auditing biobanks for compliance with ISO 20387.

Learning Outcomes:

By the end of the course, participants should be able to:

Interpret and apply the requirements of ISO 20387:2018 to assess and audit biobanking systems.
Plan and conduct assessments and audits of biobanking facilities, including preparing assessment schedules and checklists.
Evaluate and report assessment and audit findings, including nonconformities, and recommend corrective actions.
Demonstrate the skills and knowledge necessary to lead and manage assessment and audit teams effectively.
Facilitate the improvement of biobanking systems to ensure compliance with ISO 20387.

Training Content:

The training content should cover various aspects of assessing and auditing biobanking systems in compliance with ISO 20387. 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 Assessment

Assessment principles and terminology
Assessment methodologies and planning

Module 3: ISO 20387 Requirements

In-depth examination of ISO 20387 requirements
Interpretation and application of ISO 20387 clauses

Module 4: Assessment Planning and Preparation

Developing assessment objectives and criteria
Assessment scope, schedule, and checklists

Module 5: Assessment Execution

Conducting opening meetings and interviews
Gathering and evaluating evidence during assessments

Module 6: Nonconformities and Reporting

Identifying nonconformities and opportunities for improvement
Preparing assessment reports

Module 7: Corrective Action and Follow-up

Recommending corrective actions and preventive measures
Ensuring follow-up and closure of nonconformities

Module 8: Leading Assessment Teams

Leading and managing assessment teams effectively
Team dynamics and collaboration

Module 9: Assessment Challenges in Biobanking

Addressing common challenges and issues in biobanking assessments and audits
Case studies and practical scenarios

Module 10: Assessment Simulation and Role-Playing

Practical exercises and role-playing to apply assessment principles in biobanking scenarios

Module 11: ISO 20387 Lead Assessor Certification

Requirements and process for ISO 20387 lead assessor certification

Module 12: Q&A and Course Evaluation

Opportunity for participants to ask questions and provide feedback on the course

Duration: 5 days

TRAINING METHODOLOGIES

Case Study
Individual Exercises
Role Play
Group Exercises
Group Presentation
Examination

ISO 20387 Bio-banking Lead Assessor

ISO 13485 Lead Auditor Course