CERTIFIED ISO 2000:2018 LEAD AUDITOR

February 13, 2025 No Comments » Cognicert adminweb

COGNICERT CERTIFIED ISO 2000:2018 LEAD AUDITOR

*International Certification by Cognicert Limited, UK

Training schedule will be adjusted according to the agreement.

Duration: 3 days

(2 days training in class, 1 day certification exam)

Background

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.

Objectives

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

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.

Course Contents

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

Instructor

Expertindo Instructor Team

Investasi dan Fasilitas

Metode Pelaksanaan	Harga & Fasilitas
Opsi 1 – Full Self Study	Self-study Rp 2.900.000 per peserta Sertfikasi £190 Pound sterling Minimal kuota 1 peserta dan bisa request tanggal Pelaksanaan training maksimal 7 hari melalui modul yang disediakan. Ujian Sertifikasi menyesuaikan kesepakatan, maksimal 10 hari sejak pendaftaran Pelaksanaan ujian secara online Fasilitas: Sertifikat Training Softfile & Hardfile, Pengiriman Sertifikat ke Alamat Peserta, Softfile Materi, Sertifikat Cognicert Biaya belum termasuk PPN 11%
Opsi 2 – Pelatihan Online	Training Online Rp 4.900.000 per peserta Sertfikasi £190 Pound sterling Minimal kuota 1 peserta dan bisa request tanggal Pelaksanaan training selama 2 hari in class half day (08.00 – 12.00 WIB atau 13.00 – 17.00 WIB) Ujian dilaksanakan di hari ke-3 atau menyesuaikan kesepakatan. Maksimal 10 hari sejak pendaftaran. Pelaksanaan ujian secara online Fasilitas: Sertifikat Training Softfile & Hardfile, Pengiriman Sertifikat ke Alamat Peserta, Softfile Materi, Sertifikat Cognicert Biaya belum termasuk PPN 11%
Opsi 3 – Pelatihan Offline di Yogyakarta	Training Offline Rp 6.900.000 per peserta Sertfikasi £190 Pound sterling Minimal kuota 1 peserta dan bisa request tanggal Pelaksanaan training selama 2 hari in class full day (08.00 – 16.00 WIB) Tempat pelaksanaan di Hotel Malyabhara Malioboro, Yogyakarta Ujian dilaksanakan di hari ke-3 atau menyesuaikan kesepakatan. Maksimal 10 hari sejak pendaftaran. Pelaksanaan ujian secara online Fasilitas: Meeting Room, Modul Training, Sertifikat Training, Training Kits, Lunch, Coffee Break, Sertifikat Cognicert. Biaya belum termasuk PPN 11%
Opsi 4 – Pelatihan Offline Luar Yogyakarta (Jakarta, Bandung, Surabaya, dll)	Training Offline Rp 7.900.000 per peserta Sertfikasi £190 Pound sterling Minimal kuota 2 peserta dan bisa request tanggal Pelaksanaan training selama 2 hari in class full day (08.00 – 16.00 WIB) Pilihan Tempat pelaksanaan: Hotel Grand Tebu, Bandung Hotel Santika Pandegiling, Surabaya Hotel Asyana Kemayoran, Jakarta Hotel Ibis Simpang Lima, Semarang Hotel Ibis, Solo, dll Ujian dilaksanakan di hari ke-3 atau menyesuaikan kesepakatan. Maksimal 10 hari sejak pendaftaran. Pelaksanaan ujian secara online Fasilitas: Meeting Room, Modul Training, Sertifikat Training, Training Kits, Lunch, Coffee Break, Sertifikat Cognicert. Biaya belum termasuk PPN 11%