Human Factors for Combination Products
Human Factors for Combination Products

Course Description

This 3-day online course provides a comprehensive understanding of human factors in the development of combination products. It follows a structured approach based on IEC62366 and HE75 standards, focusing on patient safety, user-centered design, and ergonomics. Through a blend of theoretical knowledge and practical demonstrations, participants will learn to design, assess, and improve combination products effectively. Practical examples include an autoinjector for a rare muscular disorder, a transdermal patch for a common disorder, and a metered dose inhaler for a new respiratory illness, providing real-world context and applications.
 
Comparison with IEC62366, HE75, ISO14971, and ISO13485
 
IEC62366 provides a usability engineering process including:
- Defining intended users, use environments, and user interfaces.
- Identifying use-related hazards and critical tasks.
- Developing and implementing risk mitigation measures.
- Validating user safety and effectiveness through formative and summative evaluations.
- Documenting the usability engineering process in a Usability Engineering File.
 
HE75 offers practical design principles and methodologies for usability testing, including:
- Conducting user research and task analysis.
- Developing user profiles and scenarios.
- Performing iterative usability testing (formative and summative).
- Designing user interfaces to enhance usability and minimize errors.
 
ISO14971 framework focuses on risk management for medical devices, requiring:
- Identification of hazards.
- Estimation and evaluation of associated risks.
- Implementation of control measures to mitigate risks.
- Monitoring the effectiveness of control measures.
 
ISO13485 outlines quality management systems for medical devices, ensuring:
- Integration of design controls.
- Consistent documentation practices.
- Compliance with regulatory requirements throughout the product lifecycle.

  • Regulatory and Standards Overview:
  • EMA & FDA
  • IEC62366
  • HE75
  • ISO14971
  • ISO13485
  • User-Centered Design Process
  • Study Design for Human Factors
  • Summative Assessment
  • Regulatory Evaluation (Regulators and Notified Bodies)
  • Understand the basic definitions and key concepts of human factors and combination products
  • Recognize the regulatory and standards landscape for combination products
  • Comprehend the principles of user-centered design and ergonomics
  • Apply user-centered design principles to the development of combination products
  • Conduct comprehensive risk assessments to identify potential hazards
  • Integrate risk management processes using the ISO14971 framework
  • Perform formative assessments to evaluate early design concepts
  • Develop and implement study designs for human factors evaluation
  • Integrate ergonomics into the design of combination products
  • Conduct summative assessments and interpret results to enhance product safety and usability
  • Prepare summary documentation for regulatory submissions
  • Understand how regulatory agencies evaluate human factors and ergonomics requirements

Human Factors for Combination Products

September 24 - 26, 2024, Live Online Training
Regular price $2,250
Unit price
per 
James Pink

James Pink has over 20 years of experience in medical devices including 10 years as a lead auditor for European Notified Body. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

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9:00 AM Los Angeles time

12:00 PM New York time

5:00 PM London time

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Course Description

This 3-day online course provides a comprehensive understanding of human factors in the development of combination products. It follows a structured approach based on IEC62366 and HE75 standards, focusing on patient safety, user-centered design, and ergonomics. Through a blend of theoretical knowledge and practical demonstrations, participants will learn to design, assess, and improve combination products effectively. Practical examples include an autoinjector for a rare muscular disorder, a transdermal patch for a common disorder, and a metered dose inhaler for a new respiratory illness, providing real-world context and applications.
 
Comparison with IEC62366, HE75, ISO14971, and ISO13485
 
IEC62366 provides a usability engineering process including:
- Defining intended users, use environments, and user interfaces.
- Identifying use-related hazards and critical tasks.
- Developing and implementing risk mitigation measures.
- Validating user safety and effectiveness through formative and summative evaluations.
- Documenting the usability engineering process in a Usability Engineering File.
 
HE75 offers practical design principles and methodologies for usability testing, including:
- Conducting user research and task analysis.
- Developing user profiles and scenarios.
- Performing iterative usability testing (formative and summative).
- Designing user interfaces to enhance usability and minimize errors.
 
ISO14971 framework focuses on risk management for medical devices, requiring:
- Identification of hazards.
- Estimation and evaluation of associated risks.
- Implementation of control measures to mitigate risks.
- Monitoring the effectiveness of control measures.
 
ISO13485 outlines quality management systems for medical devices, ensuring:
- Integration of design controls.
- Consistent documentation practices.
- Compliance with regulatory requirements throughout the product lifecycle.

  • Regulatory and Standards Overview:
  • EMA & FDA
  • IEC62366
  • HE75
  • ISO14971
  • ISO13485
  • User-Centered Design Process
  • Study Design for Human Factors
  • Summative Assessment
  • Regulatory Evaluation (Regulators and Notified Bodies)
  • Understand the basic definitions and key concepts of human factors and combination products
  • Recognize the regulatory and standards landscape for combination products
  • Comprehend the principles of user-centered design and ergonomics
  • Apply user-centered design principles to the development of combination products
  • Conduct comprehensive risk assessments to identify potential hazards
  • Integrate risk management processes using the ISO14971 framework
  • Perform formative assessments to evaluate early design concepts
  • Develop and implement study designs for human factors evaluation
  • Integrate ergonomics into the design of combination products
  • Conduct summative assessments and interpret results to enhance product safety and usability
  • Prepare summary documentation for regulatory submissions
  • Understand how regulatory agencies evaluate human factors and ergonomics requirements

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Human Factors for Combination Products

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