Name: ISO 20387 Bio-banking Lead Assessor
Price: 1200 GBP
Availability: InStock

London

ISO 17025 Lead Assessor CourseCOURSE OBJECTIVES The &ldquo;ISO 17025:2018 Lead Assessor&rdquo; course provides comprehensive training in<ul style="color: rgb(122, 122, 122); box-sizing: border-box;" fr-original-style=" color: rgb(122, 122, 122);"><li fr-original-style="" style="box-sizing: border-box;">Learn how to audit each and every ISO 17025:&nbsp;2018 and ISO 17011&nbsp;requirements</li><li fr-original-style="" style="box-sizing: border-box;">Learn basic auditing skills;</li><li fr-original-style="" style="box-sizing: border-box;">Implement methods to comply with the ISO 17025:2018 requirements.</li><li fr-original-style="" style="box-sizing: border-box;">Auditing process and techniques</li><li fr-original-style="" style="box-sizing: border-box;">Assessor&rsquo;s skills and techniques</li><li fr-original-style="" style="box-sizing: border-box;">To examine the requirements of ISO 17025 from an Internal Assessor Perspective</li><li fr-original-style="" style="box-sizing: border-box;">Auditing reports process, corrective action and follow-up</li><li fr-original-style="" style="box-sizing: border-box;">Learn how to plan and conduct an internal ISO 17025 audit, and how to report audit results;</li><li fr-original-style="" style="box-sizing: border-box;">Learn how to effectively use root cause analysis as part of the ISO 17025 Laboratory procedure on corrective action</li></ul>&nbsp;WHO NEEDS THIS COURSE? &bull; Persons responsible for conducting internal and external audits according to ISO 17025:2018 requirements &bull; Persons involved in the Laboratory management systems ISO 17025:2018<h4 style="color: rgb(122, 122, 122); box-sizing: border-box;" fr-original-style=" color: rgb(122, 122, 122);">&nbsp;COURSE CONTENT</h4>&nbsp;Lesson 1: Background and Development of ISO 17025:2018Definition of ISO 17025:2018History of LaboratoryMajor Changes in ISO 17025:2018The Laboratory Management PrinciplesBenefits of ISO 17025:2018Types Of AuditsWhy Management System Audits are neededLesson 2: Introduction to the Requirements of the ISO 17025:2018 StandardInterpretations of Key TermsElements of a Laboratory SystemThe ISO 17025:2018 StandardEight Principles of Laboratory ManagementContinual Improvement CycleLaboratory Management Process ModelLaboratory System RequirementsThe Documentation Requirements of ISO 17025:2018Management ResponsibilityResource ManagementProduct RealizationMeasurement, Analysis and ImprovementLesson 3: The Process Management ApproachProcess Management ApproachThe Planning PhaseEstablish Process MeasurementsAnalyze the ProcessDesign or Redesign the ProcessProcess MappingLesson 4: Introduction to Document ControlElements of DocumentsProcess Approach to DocumentationIdentifying Documents and their OwnersTypes of DocumentsMaster Document ListDocument ControlRevisions and MaintenanceTips for Document WritersLesson 5: Introduction to Management ReviewMaking Management Review relevant to ManagementWhat will be reviewed?Establishing the ObjectivesPlanning the Management ReviewOutput of Management ReviewLesson 6: How to Deal with External Assessors &ndash; A Basic Guide for Internal AssessorsWhat is an External Laboratory Audit?What should an Employee expect during an Audit?How should Employees interact with Assessors?Lesson 7: ISO 19011:2018 and ISO 17011:2017Fundamentals of Internal AuditingDecide how to AuditPrinciples of AuditingManaging an Audit ProgrammePreparation &amp; Planning Of Audits Preparation Of checklistLesson 8: ISO 19011:2018 and ISO 17011:2017Audit ActivitiesIdentification of Non-Conformities [N/C&rsquo;s].Documenting the Audit (Audit Report)Conducting Audit Follow-UpPractical Auditing ExerciseCompetence and Evaluation of Assessors.Lesson 9:&nbsp;Creating a Corrective Action PlanWho participates?What is Root Cause Analysis?When (and when not) to use Root Cause AnalysisThe Root Cause Analysis ProcessHow to construct a Root Cause Analysis ChecklistExamples of how a well-run Root Cause Analysis Process worksCorrective and Preventive Actions<ul style="color: rgb(122, 122, 122); box-sizing: border-box;" fr-original-style=" color: rgb(122, 122, 122);"><li fr-original-style="" style="box-sizing: border-box;">Duration: 5 days</li><li fr-original-style="" style="box-sizing: border-box;">Training Methodologies<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Case Study</li><li fr-original-style="" style="box-sizing: border-box;">Individual Exercises</li><li fr-original-style="" style="box-sizing: border-box;">Role Play</li><li fr-original-style="" style="box-sizing: border-box;">Group Exercises</li><li fr-original-style="" style="box-sizing: border-box;">Group Presentation</li><li fr-original-style="" style="box-sizing: border-box;">Examination</li></ul></li></ul>

ISO 17025 Lead Assessor Course
COURSE OBJECTIVES
The “ISO 17025:2018 Lead Assessor” course provides comprehensive training in
Learn how to audit each and every ISO 17025: 2018 and ISO 17011 requirements
Learn basic auditing skills;
Implement methods to comply with the ISO 17025:2018 requirements.
Auditing process and techniques
Assessor’s skills and techniques
To examine the requirements of ISO 17025 from an Internal Assessor Perspective
Auditing reports process, corrective action and follow-up
Learn how to plan and conduct an internal ISO 17025 audit, and how to report audit results;
Learn how to effectively use root cause analysis as part of the ISO 17025 Laboratory procedure on corrective action
 WHO NEEDS THIS COURSE?
• Persons responsible for conducting internal and external audits according to ISO 17025:2018 requirements
• Persons involved in the Laboratory management systems ISO 17025:2018
COURSE CONTENT
 Lesson 1: Background and Development of ISO 17025:2018
Definition of ISO 17025:2018
History of Laboratory
Major Changes in ISO 17025:2018
The Laboratory Management Principles
Benefits of ISO 17025:2018
Types Of Audits
Why Management System Audits are needed
Lesson 2: Introduction to the Requirements of the ISO 17025:2018 Standard
Interpretations of Key Terms
Elements of a Laboratory System
The ISO 17025:2018 Standard
Eight Principles of Laboratory Management
Continual Improvement Cycle
Laboratory Management Process Model
Laboratory System Requirements
The Documentation Requirements of ISO 17025:2018
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis and Improvement
Lesson 3: The Process Management Approach
Process Management Approach
The Planning Phase
Establish Process Measurements
Analyze the Process
Design or Redesign the Process
Process Mapping
Lesson 4: Introduction to Document Control
Elements of Documents
Process Approach to Documentation
Identifying Documents and their Owners
Types of Documents
Master Document List
Document Control
Revisions and Maintenance
Tips for Document Writers
Lesson 5: Introduction to Management Review
Making Management Review relevant to Management
What will be reviewed?
Establishing the Objectives
Planning the Management Review
Output of Management Review
Lesson 6: How to Deal with External Assessors – A Basic Guide for Internal Assessors
What is an External Laboratory Audit?
What should an Employee expect during an Audit?
How should Employees interact with Assessors?
Lesson 7: ISO 19011:2018 and ISO 17011:2017
Fundamentals of Internal Auditing
Decide how to Audit
Principles of Auditing
Managing an Audit Programme
Preparation & Planning Of Audits
Preparation Of checklist
Lesson 8: ISO 19011:2018 and ISO 17011:2017
Audit Activities
Identification of Non-Conformities [N/C’s].
Documenting the Audit (Audit Report)
Conducting Audit Follow-Up
Practical Auditing Exercise
Competence and Evaluation of Assessors.
Lesson 9: Creating a Corrective Action Plan
Who participates?
What is Root Cause Analysis?
When (and when not) to use Root Cause Analysis
The Root Cause Analysis Process
How to construct a Root Cause Analysis Checklist
Examples of how a well-run Root Cause Analysis Process works
Corrective and Preventive Actions
Duration: 5 days
Training MethodologiesCase StudyIndividual ExercisesRole PlayGroup ExercisesGroup PresentationExamination

Cognicert Limited

Good Laboratory Practice (GLP)

The “ISO 17025:2018 Lead Assessor” course provides comprehensive training in

Learn how to audit each and every ISO 17025: 2018 and ISO 17011 requirements
Learn basic auditing skills;
Implement methods to comply with the ISO 17025:2018 requirements.
Auditing process and techniques

ISO 17025 Lead Assessor Course

General Admission

<div style="color: rgb(87, 87, 87); box-sizing: border-box;" fr-original-style=" color: rgb(87, 87, 87);">Cognicert ISO 20387 Bio-banking Management System Lead Assessor Course Training Overview:The &ldquo;ISO 20387 Lead Assessor Course&rdquo; 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 &ldquo;ISO 20387 Lead Assessor Course&rdquo; includes professionals and individuals who wish to become proficient in leading assessments and audits of biobanking systems. This may include:<ol fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Quality Assurance Professionals:&nbsp;Quality assurance managers, specialists, and professionals responsible for assessing and ensuring compliance with ISO 20387 in biobanking facilities.</li><li fr-original-style="" style="box-sizing: border-box;">Biobank Managers:&nbsp;Managers and administrators of biobanking facilities seeking to assess and improve their compliance with ISO 20387.</li><li fr-original-style="" style="box-sizing: border-box;">Biotechnology Industry Professionals:&nbsp;Professionals working in the biotechnology sector interested in conducting assessments and audits of biobanks.</li><li fr-original-style="" style="box-sizing: border-box;">Experienced Auditors:&nbsp;Individuals with prior experience in auditing quality management systems who wish to expand their auditing expertise to include biobanking.</li></ol>Reference Standards:The primary reference standard for this course is ISO 20387:2018 &ndash; &ldquo;Biotechnology &ndash; Biobanking &ndash; General Requirements for Biobanking.&rdquo; Additionally, the course may reference ISO 19011:2018 &ndash; &ldquo;Guidelines for Auditing Management Systems&rdquo; to provide a framework for audit practices and principles.Objectives:The objectives of the &ldquo;ISO 20387 Lead Assessor Course&rdquo; are:<ol fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Understanding ISO 20387:&nbsp;To provide participants with a comprehensive understanding of the ISO 20387 standard and its relevance to biobanking.</li><li fr-original-style="" style="box-sizing: border-box;">Assessment Principles:&nbsp;To familiarize participants with the principles of assessment, audit planning, and audit methodologies specific to biobanking.</li><li fr-original-style="" style="box-sizing: border-box;">Lead Assessor Competencies:&nbsp;To develop the competencies required to lead assessments and audits of biobanking facilities effectively.</li><li fr-original-style="" style="box-sizing: border-box;">Biobank Assessment Practices:&nbsp;To equip participants with knowledge of best practices for assessing and auditing biobanks for compliance with ISO 20387.</li></ol>Learning Outcomes:By the end of the course, participants should be able to:<ol fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Interpret and apply the requirements of ISO 20387:2018 to assess and audit biobanking systems.</li><li fr-original-style="" style="box-sizing: border-box;">Plan and conduct assessments and audits of biobanking facilities, including preparing assessment schedules and checklists.</li><li fr-original-style="" style="box-sizing: border-box;">Evaluate and report assessment and audit findings, including nonconformities, and recommend corrective actions.</li><li fr-original-style="" style="box-sizing: border-box;">Demonstrate the skills and knowledge necessary to lead and manage assessment and audit teams effectively.</li><li fr-original-style="" style="box-sizing: border-box;">Facilitate the improvement of biobanking systems to ensure compliance with ISO 20387.</li></ol>Training Content:The training content should cover various aspects of assessing and auditing biobanking systems in compliance with ISO 20387. Here&rsquo;s a breakdown of potential content areas:Module 1: Introduction to ISO 20387<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Overview of ISO 20387:2018 and its scope</li><li fr-original-style="" style="box-sizing: border-box;">The importance of ISO 20387 in biotechnology biobanking</li></ul>Module 2: Principles of Assessment<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Assessment principles and terminology</li><li fr-original-style="" style="box-sizing: border-box;">Assessment methodologies and planning</li></ul>Module 3: ISO 20387 Requirements<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">In-depth examination of ISO 20387 requirements</li><li fr-original-style="" style="box-sizing: border-box;">Interpretation and application of ISO 20387 clauses</li></ul>Module 4: Assessment Planning and Preparation<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Developing assessment objectives and criteria</li><li fr-original-style="" style="box-sizing: border-box;">Assessment scope, schedule, and checklists</li></ul>Module 5: Assessment Execution<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Conducting opening meetings and interviews</li><li fr-original-style="" style="box-sizing: border-box;">Gathering and evaluating evidence during assessments</li></ul>Module 6: Nonconformities and Reporting<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Identifying nonconformities and opportunities for improvement</li><li fr-original-style="" style="box-sizing: border-box;">Preparing assessment reports</li></ul>Module 7: Corrective Action and Follow-up<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Recommending corrective actions and preventive measures</li><li fr-original-style="" style="box-sizing: border-box;">Ensuring follow-up and closure of nonconformities</li></ul>Module 8: Leading Assessment Teams<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Leading and managing assessment teams effectively</li><li fr-original-style="" style="box-sizing: border-box;">Team dynamics and collaboration</li></ul>Module 9: Assessment Challenges in Biobanking<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Addressing common challenges and issues in biobanking assessments and audits</li><li fr-original-style="" style="box-sizing: border-box;">Case studies and practical scenarios</li></ul>Module 10: Assessment Simulation and Role-Playing<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Practical exercises and role-playing to apply assessment principles in biobanking scenarios</li></ul>Module 11: ISO 20387 Lead Assessor Certification<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Requirements and process for ISO 20387 lead assessor certification</li></ul>Module 12: Q&amp;A and Course Evaluation<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Opportunity for participants to ask questions and provide feedback on the course</li></ul>Duration: 5 daysTRAINING METHODOLOGIES<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Case Study</li><li fr-original-style="" style="box-sizing: border-box;">Individual Exercises</li><li fr-original-style="" style="box-sizing: border-box;">Role Play</li><li fr-original-style="" style="box-sizing: border-box;">Group Exercises</li><li fr-original-style="" style="box-sizing: border-box;">Group Presentation</li><li fr-original-style="" style="box-sizing: border-box;">Examination</li></ul></div>

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

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.


2 Courses

ISO 17025 Lead Assessor Course

By Cognicert Limited

ISO 20387 Bio-banking Lead Assessor

By Cognicert Limited

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