Human Factors and Risk Management Leading Post-Conference Workshop at Pre-Filled Syringes San Francisco

SMi Reports: The inaugural Pre-filled Syringes San Francisco Conference on September 14th and 15th, 2020 will also have two post conference workshops taking place on the 16th of September.

San Francisco, CA, June 10, 2020 --( SMi Group is holding the inaugural Pre-filled Syringes San Francisco conference, taking place on the 14th and 15th September 2020, in San Francisco, USA. Along side the conference there will also be running post conference workshops.

"Human Factors and Risk Management"
Workshop Leaders: Denise Forkey, Senior Human Factors Engineer, Userwise
Miles Buroker, Human Factors Engineer, Userwise

Overview of the workshop:
Risk management is central to the development of any medical device or combination product. Integration of Human Factors Engineering processes into the development of your device ensures the prioritization of safety and efficacy when in the hands of the end user. This workshop will teach best practices in identifying use errors and analysing risks stemming from use of medical products. We will review pertinent definitions and strategies for determining use-related risk and perform exercises to train these skills.

To find out more about The Inaugural Pre-Filled Syringes San Francisco conference and workshops please visit:

Why You Should Attend:
• Integration of Human Factors Engineering processes in risk management saves time and money in product development
• Effective identification of use-related risk helps inform constructive design decisions
• Mitigation of use-related risk improves treatment outcomes for end users
• Understanding the methods used to assess use-related risk will improve the efficiency and acumen of your organization

Who should attend:
• Drug-delivery developers
• Medical Device Engineers
• Primary Packaging material designers
• Secondary packagers
• Smart device developers
• Training device developers
• Device-safety solution providers
• Drug developers

About the Workshop Leaders:

Denise Forkey has over 25 years of experience in medical device and combination product testing with experience in human factors engineering, pre-clinical testing, R&D and quality engineering. The last 5 years Denise has directed her efforts to Human Factors and Usability Engineering of complex medical devices, combination products, and consumer based medical products. She partners with UserWise clients on human factors strategy for FDA and international human factors submissions as well as any and all aspects of the usability engineering process. Denise has experience developing use-related risk analyses, preparing documentation for and executing formative and summative usability evaluations and human factors validation testing.

Miles first is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA. His focus is predominantly on combination products.

The brochure with the full workshop agenda, and speaker line-up is available online:

Pre-filled Syringes San Francisco
14TH – 15TH September 2020
Hyatt Centric Fisherman's Wharf, San Francisco

Proudly sponsored by: Credence MedSystems | Mitsubishi Gas Chemical | PHC Corporation | Plastic Ingenuity | Steris | Steri-Tek | Sumitomo | Zeon Speciality Materials|

For media queries please contact Jinna Sidhu at or call +44 (0)20 7827 6088.

About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at
SMi Group
Jinna Sidhu
+44 (0) 20 7827 6088