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2 days Seminar on FDA Software Regulation - Medical Devices
Presented By Complianzworld
Thursday, December 4th at 9:00am PST
Online sale ends: 12/03/14 at 6:00pm PST
San Francisco, CA 94109
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Speaker: Casper E. Uldriks


Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value.

He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.


Course Description:

This 2 day course will explains FDA’s regulatory approach to software regulation, its use of guidance and risk classification for software controls. You will understand how FDA’s regulatory program covers a number of software topics, such as: validation, clinical management applications, interoperability of multiple sourced devices, cybersecurity, home use and the burgeoning market of mobile applications (mobile apps) for diagnostic or treatment purposes. You will understand how these topics provide great business opportunities but also have inherent risks with direct or indirect health consequences. Moreover, you will be able to see how important cybersecurity will be in the future and your options for managing it.

FDA’s historical experience with software problems is extensive, if not dramatic, and has led to some unprecedented changes in how it will regulate software based devices in the future. You will understand the importance of applying the Total Product Life Cycle paradigm in your product improvement and design practices. The course will also point out future software based uses and how it may affect immediate patient care, allied healthcare programs and social services. The course will explore the limitations of government regulation, risk management, labeling for home use and catastrophic failure. Applying human factors considerations will become critical as healthcare becomes increasingly decentralized and the patient population profile becomes more diverse. Attendees will leave with a clearer understanding of the issues FDA covers in its regulatory program.

Reasons to attend:

  • Understand FDA’s job and your obligations
  • Identify how you can anticipate FDA’s regulatory initiatives
  • Identify and manage the risks inherent in your software based products
  • See how FDA expects you to learn from your mistakes
  • Start to identify who is responsible for software problems and how to limit it liability
  • Plan for changes in patient care and wellness programs

Target Audience:

  • Software developers and servicers
  • Institutional healthcare risk and liability managers
  • Regulatory affairs directors for medical device firms
  • Medical practice group management

 [Click Hear for Agenda & More information]


Day 1:

8:00 – 8:30 AM: Registration

8:30 – 10:00 AM:

  • FDA legal authority
  • FDA regulation
    • Quality System regulation
    • Design validation
    • Corrective and Preventive Action (CAPA) obligations
    • Total Product Life Cycle (TPLC)

10:00 – 10:15 AM: Break

10:15 – 12:00 noon:

  • FDA regulations (continued)
    • Medical Device Reporting
    • Reports of Corrections and Removals
      • Regulation
      • Draft guidance – potential impact
      • Software “Bugs”

12:00 – 12:45 PM: Lunch

12:45 – 2:15 PM:

  • Medical Device Data Systems (MDDS) Rule
  • HHS Office of the National Coordinator:

Health Information Technology: regulation and policy

  • FDA risk paradigm for software regulation

2:15 – 2:30 PM: Break

2:30 – 4:00 PM:

  • Software Marketing and Misbranding Violations
  • Generic Software Platforms
  • Customizing software and regulatory liability
  • Updating platforms and revising customized programs

Day 2:

8:30 – 10:00 AM:

  • Interoperability
    • Software use and failures
    • Verification
    • Responsibility
    • Voluntary Standards
    • User back up plans and support

10:00 – 10:15 AM: Break

10:15 – 12:00 noon:

  • Cyber Security
    • Hackers
    • Protection
    • Response plan

12:00 – 12:45 PM: Lunch

12:45 – 2:15 PM:

  • Mobile Apps
    • Is it a device?
    • Risk Level Criteria
    • Diagnostic and. Treatment Uses
    • Consumer and Home Medical Care
    • Impact on Health Care Practices

2:15 – 2:30 PM: Break

2:30 – 3:30 PM:

  • FDA inspection
    • Scope of inspectional coverage
    • Software Validation
    • Root cause investigations and recalls

To Enroll for This Program Today  please click hear

Thank you & Regards,

Kevin Roberts,


Call us at this Toll Free number: +1-866-978-0800


Presented By

9:00am to 11:00am
Doors open at 9:00am

General Admission: $1,299.00


complianzworld<br> San Francisco, 94109


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