ISO INTRODUCTION
The standards published by ISO undergo changes periodically, to reflect the best-suited practices over the changing times. ISO series of standards For a business unit to successfully set up and ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES Or get maximum benefits from an established management system, auditors within the organization have to be trained to assess the system against ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES They must also be able to assess their suppliers required management system to support own Quality Initiative.
To increase professionalism, quality auditors also seek formal registration with the IAF-AB (UK) one of the prerequisites for such registration requires the quality auditors and practitioners to successfully complete an IAF-AB (UK) approved auditor training.
OBJECTIVE OF THE COURSE:
The objective of the course is to illustrate the importance of the 4 Days Advance Training Programe role, skills and competency in bearing the ultimate responsibility for the effective performance of the audit team. A practical and intensive course for training quality professionals to External, Internal and manage third and second party audits of a ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES. Course describes how to plan and perform an audit, report findings, conduct opening and closing meetings and establish follow-up action. You will understand by the end of the course How regular auditing by an audit team directed by a competent internal auditor is the foundation of an effective ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES On completion of the course you will have the necessary skills and the experience to Internal Audit and manage your own audits. The learning process will include a Series of tutorials, exercises, culminating in both practical and written examination. Delegates will be supplied with a bound set of comprehensive course notes.
COURSE CONTENTS:
- Introduction to ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES Vocabulary & understanding definitions
- Introduction to ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES Need for Internal Quality Audits
- Auditing Techniques
- Conducting Internal Quality Audits
- Course Examination with minimum 50% passing marks.
Day 1: Introduction to ISO 20387 and Biobanking Concepts
Session 1: Overview of ISO 20387
- Understanding ISO 20387 Standards
- Introduction to ISO 20387 and its relevance to biobanks.
- Key principles and scope of the standard.
- Importance of Biobank Accreditation
- Benefits of ISO 20387 accreditation for biobanks and stakeholders.
Session 2: Fundamentals of Biobanking
- Defining Biobanks
- Overview of biobanks, types, and functions.
- Types of Biological Materials
- Different categories of biological materials collected in biobanks (e.g., tissues, blood, DNA).
Session 3: Biological Material and Data Management
- Data Collection and Management
- Procedures for the collection, storage, and retrieval of biological samples.
- Information Systems in Biobanks
- Overview of database systems used in biobanking.
Session 4: Ethical and Regulatory Considerations
- Ethics in Biobanking
- Ethical issues surrounding the collection and use of biological materials.
- Regulatory Frameworks
- Overview of national and international regulations governing biobanks.
Group Activity:
- Participants will form groups to discuss the ethical implications of biobanking and present their findings.
Day 2: Implementing ISO 20387 Requirements
Session 5: Quality Management Systems (QMS) in Biobanks
- Establishing a QMS
- Key components of a QMS for biobanks.
- Document Control and Record Keeping
- Best practices for document management in compliance with ISO 20387.
Session 6: Personnel Competence and Training
- Ensuring Competence
- Training and competency requirements for biobank personnel.
- Ongoing Professional Development
- Strategies for maintaining up-to-date knowledge and skills.
Session 7: Collection and Handling of Biological Materials
- Standard Operating Procedures (SOPs)
- Developing SOPs for the collection, processing, and storage of biological materials.
- Sample Integrity and Traceability
- Importance of maintaining sample integrity and tracking processes.
Session 8: Risk Management in Biobanking
- Identifying Risks
- Common risks associated with biobank operations.
- Mitigation Strategies
- Approaches for managing and mitigating identified risks.
Group Activity:
- Teams will develop a draft SOP for a specific aspect of biobanking, including sample handling and storage.
Day 3: Accreditation Process and Best Practices
Session 9: Preparing for ISO 20387 Accreditation
- Understanding the Accreditation Process
- Steps involved in achieving ISO 20387 accreditation.
- Documentation and Evidence Requirements
- Key documents needed for the accreditation application.
Session 10: Internal Audits and Compliance Checks
- Conducting Internal Audits
- Planning and executing internal audits to assess compliance.
- Audit Tools and Techniques
- Best practices for effective auditing in biobank operations.
Session 11: Case Studies of Successful Biobank Implementation
- Review of Industry Examples
- Analysis of successful case studies demonstrating ISO 20387 implementation.
- Lessons Learned
- Key takeaways that can be applied to participants’ biobank operations.
Session 12: Continuous Improvement in Biobanking
- Feedback Mechanisms
- Implementing systems for feedback and continuous improvement.
- Performance Measurement
- Key performance indicators (KPIs) for assessing biobank operations.
Group Activity:
- Participants will review a case study on a biobank’s journey toward accreditation and identify strengths and weaknesses in their approach.
Day 4: Future Trends and Innovations in Biobanking
Session 13: Innovations in Biobanking
- Emerging Technologies
- Discussion on new technologies affecting biobanking (e.g., biobanking automation, cloud storage).
- Data Sharing and Collaboration
- Importance of collaboration in advancing biobank research and data sharing.
Session 14: Preparing for Future Challenges
- Anticipating Future Trends
- How biobanks can adapt to changing regulations and research landscapes.
- Sustainability in Biobanking
- Strategies for implementing sustainable practices in biobank operations.
Session 15: Developing a Strategic Plan for Biobanks
- Strategic Planning Fundamentals
- How to develop a strategic plan that aligns with ISO 20387 requirements.
- Engaging Stakeholders
- Techniques for engaging stakeholders in the planning process.
Session 16: Course Review and Key Takeaways
- Recap of Major Topics
- Summary of essential concepts covered throughout the training.
- Personal Action Plans
- Participants will develop individual action plans for implementing ISO 20387 in their biobank.
Session 17: Certification of Completion
- Issuing Certificates
- Participants receive certificates of completion for the training program.
- Networking Opportunities
- Facilitating networking among participants for future collaboration and support.
Learning Outcomes:
By the end of this training, participants will:
- Understand the structure and requirements of ISO 20387 for biobanks.
- Be equipped to implement quality management systems and SOPs for biological material handling.
- Gain skills in auditing, compliance, and risk management specific to biobanks.
- Learn from case studies and industry best practices to enhance their biobank operations.
- Prepare for the accreditation process and maintain compliance with ISO 20387.
Delivery Method:
- Classroom Training: Interactive lectures, group discussions, case studies, and hands-on activities.
- Distance Learning: Virtual presentations, downloadable resources, quizzes, and online discussions.
Materials Provided:
- Comprehensive course manual covering ISO 20387 requirements, implementation strategies, and case studies.
- Templates for SOPs, audit checklists, and quality management documentation.
- Certificate of completion for participants.
This training program aims to equip participants with the advanced knowledge and practical skills necessary for achieving ISO 20387 accreditation in biobanking, ultimately ensuring the integrity and quality of biological materials and data collections.
For detail of contents refer our website at www.ukjas.com
- WHO SHOULD ATTEND:
1) All employees whose work responsibility directly affects ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES
2) Those individuals willing to take up external auditing as a future profession by becoming an independent auditor.
3) Those who intend to enroll themselves to IAF-AB (UK) Registration Schemes of ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES
4) Management Representatives responsible for effective implementation and execution of ISO ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES
- FACILITIES:
All facility for delegates covering lecture hall, tea and lunch will be arranged by Client or if you are attending the course at UKJAS Offices. UKJAS institute will arrange the above facility.
- COURSE DETAILS:
Detail program of every days training course will be sent / given on the first day to the delegates on registration.
- DURATION:
Four days Advance Training Programe ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES [Timings: 10.00 am to 6.00 pm]
FEES:
- 4 Days Advance Training program of ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES and any other program is Rs 18000+18%GST
Payment should be made by Cheque / DD in favor of “UKJAS Accreditation Pvt Ltd, Mumbai
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