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
Interface Analysis Associates
San Jose, CA | May 20-21, 2015
|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!
- How to utilize Human Factors expert inputs, data and user research methods early during product development of a new device or combination drug product.
- The critical Human Factors design principles that should be optimized for every device.
- The roadmap for Human Factors design validation that can be applied in every development project to reduce development delays and improve the likelihood of approval.
- How to establish reasonable Human Factors/design validation expectations with FDA reviewers. Understanding the differences in CDRH, CEDR, and CBER Human Factors expectations.
- How to approach generics competitors vs. generic swap vs. new drug device submissions. The differences can be the difference between success and failure!
- Understanding the paradigm shift from conventional regulatory, legal and quality thinking. Human factors has its own rules—the sooner you learn them, the better!
- Why utilizing existing FDA Human Factors guidance documents can be dangerous. What you know can hurt you!
- It all starts with the risk analysis! Why your risk analysis is all wrong and how to fix it.
- How to prepare for the validation process: Why you may not be ready to validate, even though you think you are.
- How to write and submit a Human Factors summative validation test protocol to the FDA. What’s the best approach? And, do you have to submit one?
- When to validate? Before or after your Phase 3? And why?
- Key techniques for validation study success. Why so many validation attempts fail.
- When and how to validate labeling and differentiation.
- Avoiding failure. The top 10 mistakes you and your company will never make again!
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
- 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.
- HF Staff (especially junior personnel and recent hires)
- Product and Device Management
- Regulatory and Quality personnel
- Product Packaging and Labeling
- Device Engineering and Design
Anthony D. Andre, Ph.D., CPE
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.