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Our mission: Bringing practical business and technical intelligence to today's structured cabling professionals

For more than 30 years, Cabling Installation & Maintenance has provided useful, practical information to professionals responsible for the specification, design, installation and management of structured cabling systems serving enterprise, data center and other environments. These professionals are challenged to stay informed of constantly evolving standards, system-design and installation approaches, product and system capabilities, technologies, as well as applications that rely on high-performance structured cabling systems. Our editors synthesize these complex issues into multiple information products. This portfolio of information products provides concrete detail that improves the efficiency of day-to-day operations, and equips cabling professionals with the perspective that enables strategic planning for networks’ optimum long-term performance.

Throughout our annual magazine, weekly email newsletters and 24/7/365 website, Cabling Installation & Maintenance digs into the essential topics our audience focuses on.

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  • Technology: We evaluate product innovations and technology trends as they impact a particular product class through interviews with manufacturers, installers and users, as well as contributed articles from subject-matter experts.
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Human Factors and Usability Engineering in the Development of Drug Delivery Products - Two-Day Workshop Equips Product Developers with Human Factors Testing Skills (September 16-17, 2025) - ResearchAndMarkets.com

The "Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course (ONLINE EVENT: September 16-17, 2025)" has been added to ResearchAndMarkets.com's offering.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development or need to provide the regulators with specific usability data for their device to comply with the MDR.

The format for the day will be interactive with the presenter sharing his experiences as a specialist with extensive knowledge and understanding of the requirements of the MDR, IEC 62366 and FDA human factors Guidance. There will be questions posed for discussion and delegates will work through some of the key aspects of performing a successful human factors study.

Benefits of attending include:

  • Understand the requirements of IEC 62366 and FDA human factors Guidance
  • Know how to provide the regulators with specific usability data for your device
  • Understand human factors and the design process
  • Learn how to validate combination products
  • Consider human factors and risk
  • Discuss generic combination products - ANDAs and HF
  • Find out what HF data FDA require for biosimilars

Certifications:

  • CPD: 12 hours for your records
  • Certificate of completion

Who Should Attend:

This event will be beneficial to those working in the following areas:

  • Engineering and device development
  • Packaging
  • Regulatory affairs
  • Quality systems
  • Quality assurance
  • Risk management
  • Marketing
  • Usability and human factors engineering

Course Agenda

Introduction

  • Scope of the training
  • Expectations for the training

Background to human factors

  • Human factors, usability and ergonomics defined
  • Trends in drug delivery device technology
  • Use errors - scale, scope and implications
  • Defining the user interface
  • Usability research, clinical research and market research compared

Legal and regulatory requirements

  • US law and design control - implications for HF
  • MDR and usability requirements
  • Article 117 and implications for combination products
  • UK medical device regulations

IEC62366, FDA guidance and expectations

  • IEC62366 usability engineering process
  • FDA human factors guidance
  • ISO14971 applied to combination products
  • EMA guidance on combination products
  • Chinese human factors guidance 2022

Human factors methods and best practices

  • Human factors engineering
  • Perception, cognition and action model
  • Heuristic analysis

Design control, design and development

  • Design and development planning
  • Role of human factors in design control
  • UE methods and outputs
  • UE integration with combination product development

User needs & user interface specifications

  • Regulatory requirements for user needs
  • Defining formal user needs
  • User requirements and the design trace matrix
  • Building a user interface specification

Formative and validation testing methods

  • Formative testing methods
  • Human factors validation methods

Use-related risk

  • Regulatory requirements for use-related risk
  • ISO14971 applied to combination products
  • Risk analysis methods
  • Risk control
  • Residual risk analysis

HF and clinical trials

  • How HF and clinical trials differ
  • How to gather HF data during clinical trials
  • Changing the user interface during the trial program
  • HF requirements for INDs and IDEs

Technical data requirements

  • HF contents of a design history file
  • HF contents of a EU technical file

Predicate devices, platform devices and post-market surveillance

  • Platform devices - how to incorporate HF
  • Platform device due diligence
  • Post-market HF requirements - US and EU

Generic devices, biosimilars and ANDAs

  • How to do a database and literature search for known use problems
  • ANDA submissions and HF
  • ANDA versus 505(b)(2) HF requirements
  • FDA HF requirements for biosimilars

Practicalities - how to stay legal

  • GDPR, IRB, HIPAA and the Sunshine Act
  • When to apply for ethics/IRB approval
  • Common GDPR problems during HF testing

Wrap-up

  • Common pitfalls and top tips
  • Top tips

For more information about this training visit https://www.researchandmarkets.com/r/ii02pg

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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