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Mastering ISO 14155; Regulatory Compliance for Medical Device Clinical Trials

Mastering ISO 14155; Regulatory Compliance for Medical Device Clinical Trials

$199.00
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What does the ISO 14155 course cover?

ISO 14155 is covered here in 10 modules: Introduction to ISO 14155 and Regulatory Compliance, Clinical Trial Design and Management: Risk management and safety reporting, Regulatory Requirements for Clinical Trials: Regulatory reporting and compliance and 7 more. The outline lists 39 specific topics, opening with overview of ISO 14155 and its importance in medical device clinical trials and closing with best practices.

How do you approach ISO 14155 step by step?

The work is sequenced in 10 stages. It starts with Introduction to ISO 14155 and Regulatory Compliance, moves through Clinical Trial Design and Management: Risk management and safety reporting and Regulatory Requirements for Clinical Trials: Regulatory reporting and compliance, and ends at Clinical Trial Regulatory Update: Strategies for implementing regulatory changes.

What is in Module 1 of the ISO 14155 course?

Module 1 is Introduction to ISO 14155 and Regulatory Compliance. It works through overview of ISO 14155 and its importance in medical device clinical trials, regulatory framework for medical device clinical trials and understanding the role of regulatory authorities and sponsor responsibilities. It sets the vocabulary the remaining 9 modules build on.

How is the ISO 14155 course delivered?

The ISO 14155 course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.

How much does the ISO 14155 course cost?

The ISO 14155 course is $199 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.

Closely related courses: Clinical Trial Compliance Efficiency Playbook, Clinical Trials in Predictive Analytics Dataset, Data-Driven Clinical Trials, AI-Powered Clinical Trials.

More answers: what you get with every course, refund policy, all help answers.

Mastering ISO 14155: Regulatory Compliance for Medical Device Clinical Trials



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of the regulatory requirements for medical device clinical trials, as outlined in ISO 14155. Through interactive and engaging lessons, participants will gain the knowledge and skills necessary to ensure compliance with regulatory standards and successfully manage clinical trials.



Course Objectives

  • Understand the regulatory framework for medical device clinical trials
  • Interpret and apply the requirements of ISO 14155
  • Develop a comprehensive understanding of clinical trial design and management
  • Ensure compliance with regulatory standards and Good Clinical Practice (GCP)
  • Manage clinical trial data and documentation effectively
  • Prepare for regulatory audits and inspections


Course Outline

Module 1: Introduction to ISO 14155 and Regulatory Compliance

  • Overview of ISO 14155 and its importance in medical device clinical trials
  • Regulatory framework for medical device clinical trials
  • Understanding the role of regulatory authorities and sponsor responsibilities

Module 2. Clinical Trial Design and Management: Risk management and safety reporting

  • Clinical trial design and protocol development
  • Investigator selection and site management
  • Clinical trial monitoring and data management
  • Risk management and safety reporting

Module 3. Regulatory Requirements for Clinical Trials: Regulatory reporting and compliance

  • Informed consent and patient recruitment
  • Clinical trial documentation and record-keeping
  • Regulatory reporting and compliance
  • Good Clinical Practice (GCP) and quality assurance

Module 4. Data Management and Statistical Analysis: Data protection and confidentiality

  • Data management and data quality assurance
  • Statistical analysis and data interpretation
  • Clinical trial reporting and publication
  • Data protection and confidentiality

Module 5. Regulatory Audits and Inspections: Corrective and preventive action (CAPA)

  • Preparing for regulatory audits and inspections
  • Understanding audit and inspection procedures
  • Responding to audit and inspection findings
  • Corrective and preventive action (CAPA)

Module 6. ISO 14155 and GCP Compliance: Auditing and monitoring for

  • Understanding ISO 14155 and GCP requirements
  • Implementing ISO 14155 and GCP in clinical trials
  • Ensuring compliance with ISO 14155 and GCP
  • Auditing and monitoring for ISO 14155 and GCP compliance

Module 7. Clinical Trial Ethics and Patient Safety: Risk management and safety reporting

  • Clinical trial ethics and patient safety principles
  • Informed consent and patient recruitment
  • Risk management and safety reporting
  • Clinical trial monitoring and data management

Module 8. Clinical Trial Project Management: Project planning and budgeting

  • Clinical trial project management principles
  • Project planning and budgeting
  • Project execution and monitoring
  • Project closure and evaluation

Module 9. Clinical Trial Quality Assurance: Quality planning and quality control

  • Clinical trial quality assurance principles
  • Quality planning and quality control
  • Quality assurance and quality improvement
  • Auditing and monitoring for quality assurance

Module 10. Clinical Trial Regulatory Update: Strategies for implementing regulatory changes

  • Regulatory updates and changes in clinical trial regulations
  • Impact of regulatory changes on clinical trials
  • Strategies for implementing regulatory changes
  • Best practices for staying up-to-date with regulatory changes


Certificate of Completion

Upon completion of this course, participants will receive a Certificate of Completion issued by The Art of Service.



Course Features

  • Interactive and engaging lessons
  • Comprehensive and up-to-date content
  • Expert instructors with industry experience
  • Personalized learning experience
  • Flexible learning format (online, self-paced)
  • Mobile-accessible and user-friendly platform
  • Community-driven discussion forum
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking


Who Should Take This Course?

  • Clinical trial managers and coordinators
  • Regulatory affairs professionals
  • Quality assurance professionals
  • Clinical research associates
  • Medical device industry professionals
  • Pharmaceutical industry professionals
  • Biotechnology industry professionals
  • Anyone involved in clinical trials and regulatory compliance
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