TWO DAYS HUMAN FACTORS WORKSHOP - WHEN FAILURE IS NOT AN OPTION

The Secrets to Successful Human Factors Validation for Combination Drug Products

A 2-Day Human Factors Comprehensive & Interactive Workshop
Presented By: Dr. Anthony D. Andre, CPE
Founding Principal
Interface Analysis Associates

San Jose, CA | May 20-21, 2015

For more information, email to: 800usability@gmail.com OR call 1 (408) 342-9052
(ask for Maggie)

The Sainte Claire Hotel San Jose, CA
One of California’s genuine grand hotels – a stately hotel with majestic, plush interiors situated in the heart of downtown San Jose.
  FDA HF Validation Done Right!
IAA is a leading healthcare human factors, usability, and ergonomics consultancy, in business since 1993.
 

Through interactive lecture, discussion of numerous case studies, and promotion of Human Factors science, this advanced and comprehensive workshop on Human Factors (HF) validation of combination drug products (and medical devices) is intended to enhance your understanding of the following key elements, and more!

IAA Human Factors/ Ergonomics Healthcare Services:
  • Medical device and drug delivery device design
  • Training Procedures and Scripts
  • Instructions for Use; Carton Labeling; Quick Reference Guides
  • User-centered needs analyses for special populations (ethnography, contextual inquiry)
  • Expert Human Factors reviews of products, labeling, instruction, test plans, FDA correspondence
  • Usability Testing (we operate 2 own custom labs)—assessment, formative, and summative.
  • Validation protocol development, study execution and reporting
  • Differentiation/Labeling Studies
  • Needle Safety Validation Studies
  • FDA regulatory strategy guidance
  IAA Device and Combination Product Experience:
  • Pre-Filled Syringes
  • Pre-Filled Safety Syringes
  • Vial and Syringe Kits
  • Reconstitution Kits/Pens
  • Infusion Pumps
  • Micro-Infusers / Patch Pumps
  • Disposable Pens
  • Reusable Pens
  • Disposable Autoinjectors
  • Reusable Autoinjectors
  • Inhalers and Misters (nasal, oral)
  • Drug Patches
  • Stimulators
  • Applicators (nasal, oral, anal, vaginal)
  • Software Applications and Smartphone Apps
  • Telemetry Systems
  • Diagnostic Systems

Patients – Healthcare Professionals – Caregivers - Bystanders

Who Should Attend?

This workshop is intended for individuals working in combination product development, device manufacturing, quality assurance, regulatory affairs, product packaging and labeling, and user-training and marketing roles in the pharmaceutical and medical device industries.

Anthony D. Andre, Ph.D., CPE
Founding Principal
Interface Analysis Associates

Dr. Anthony Andre holds a Ph.D. in Engineering Psychology (Human Factors) and is a board certified Professional Ergonomist. He heads an award-winning Human Factors and Ergonomics consultancy that specializes in patient safety research, drug delivery device design, usability testing and Human Factors regulatory process consulting. His firm has a broad range of biotech, pharma and medical device clients and has been instrumental in obtaining approval of various drug delivery devices, combination products and medical devices/systems under the FDA’s most recent Human Factors requirements. Dr. Andre specializes in regulatory strategies for FDA Human Factors approval, especially when companies have failed in previous attempts. His unique approach has resulted in a 100% success rate for the hundreds of medical devices and combination drug products for which he has led the HF effort.

Since 1993 Dr. Andre has also served as a Professor of Human Factors and Ergonomics at San Jose State University. His other notable accomplishments include: President of the Human Factors and Ergonomics Society, Elected Fellow of the Human Factors and Ergonomics Society, and Founding Chair of the Annual International Symposium on Human Factors and Ergonomics in Healthcare.

For more information, email to: 800usability@gmail.com OR call 1 (408) 342-9052
(ask for Maggie)