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 2 Days 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 Biobank Fundamentals
Session 1: Overview of ISO 20387
- Introduction to ISO 20387: Scope and purpose
- Historical context and development of the standard
- Importance of ISO 20387 in biobanking and research
- Key principles of biobank management and ethical considerations
Session 2: Understanding Biobanks and Their Functions
- Definition and types of biobanks: Human, animal, plant, and microbial
- Role of biobanks in research and medicine
- Key components of biobanking: Biological material, data, and metadata
Session 3: Requirements of ISO 20387
- Detailed examination of the requirements for biobanks according to ISO 20387
- Quality management systems (QMS) in biobanks
- Documentation and record-keeping for compliance
- Roles and responsibilities in biobank operations
Session 4: Implementing Quality Management in Biobanks
- Establishing and maintaining a quality management system tailored for biobanks
- Standard operating procedures (SOPs) for collection, storage, and retrieval of biological materials
- Risk management strategies specific to biobanking operations
Group Activity:
- Participants will analyze a case study of a biobank, identifying compliance gaps and proposing solutions based on ISO 20387 standards.
Day 2: Practical Applications, Audits, and Continuous Improvement
Session 5: Managing Biological Material and Data in Biobanks
- Best practices for collection, processing, and storage of biological materials
- Data management and integration of biological and clinical data
- Ethical and legal considerations in biobanking: Consent, privacy, and data sharing
Session 6: Conducting Audits and Assessments for ISO 20387 Compliance
- Best practices for conducting internal audits of biobank operations
- Techniques for assessing compliance with ISO 20387
- Quality control and assurance measures in biobanking
Session 7: Case Studies of Successful ISO 20387 Implementation
- Real-world examples of biobanks that have successfully achieved ISO 20387 accreditation
- Discussion of challenges faced during the accreditation process and solutions implemented
- Strategies for maintaining compliance and fostering continuous improvement
Session 8: Future Trends in Biobanking and ISO 20387
- Emerging technologies and trends in biobanking (e.g., biobanking informatics, precision medicine)
- The evolving regulatory landscape and implications for biobanks
- Preparing for future changes and updates in ISO 20387 and related standards
Group Activity:
- Teams will create a mock internal audit report for a biobank, highlighting key findings, recommendations, and action plans for improvement.
Closing Session:
- Q&A session to clarify participant queries
- Discussion on the importance of ongoing education and training in ISO 20387 compliance
- Feedback collection from participants regarding the training programme
Learning Outcomes:
Upon completion of this training programme, participants will be able to:
- Understand the principles and requirements of ISO 20387 in the context of biobanks.
- Implement an effective quality management system tailored for biobanking operations.
- Conduct audits and assessments to ensure ongoing compliance with ISO 20387.
- Recognize future trends and innovations in biobanking that may impact the life sciences sector.
Delivery Method:
- Classroom Training: Interactive lectures, group discussions, case studies, and hands-on activities.
- Distance Learning: Recorded lectures, online discussions, virtual group activities, and assessment quizzes.
Materials Provided:
- Course handbook and supplementary materials
- Access to online resources and additional reading materials
- Certificates of completion
This structured content is designed to equip participants with the knowledge and skills necessary to enhance their understanding and implementation of ISO 20387 for effective biobanking technical services.
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:
Two day 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:
- 2 Day Training program of ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND COLLECTIONS TECHNICAL SERVICES and any other program is Rs 10500+18%GST
Payment should be made by Cheque / DD in favor of “UKJAS Accreditation Pvt Ltd, Mumbai
Reviews
There are no reviews yet.