FDA Device Software Regulation

Course "FDA Device Software Regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost

Overview:

Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device's performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions regarding patient management and treatment. FDA's risk classification will gradually clarify how it intends to manage the health risks. Software use has become increasingly complicated with the expansion of software applications, for example: cybersecurity, interoperability, mobile medical "apps," home use and remote use. Another growing concern is the public's use of software programs to manage their health issues rather than go to a healthcare professional.

The increasing sophistication and venue for use create new software design validation considerations. In many instances, validation is limited to the immediate use of the software rather than its environment of use, its performance with other software programs and software hacking. When software causes a problem, fixing the malfunction or "bug" may be more difficult as software becomes more sophisticated, customized by users and placed in a network system. In these kinds of circumstances, it is difficult to decide who is responsible for managing and fixing the software problems. This becomes a major regulatory headache for FDA and generates business-to-business conflicts. When firms are designing and marketing software, they should be mindful the unknowns that lurk in the future of software regulated as a device by FDA.

Why should you attend?

For decades, firms have experienced serious problems with software and have been at a loss to make a well-informed follow up. Software problems represent one of the most common root causes for recalls that are associated with deaths and serious injuries beyond what should be necessary to quantify. FDA sees firms revise software only to create more problems rather than solve them. The infusion pump industry is a classic example that drove FDA to implement a new rigorous paradigm for device evaluation.

The growth of the medical software industry outpaces how FDA's regulatory process is designed. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. You need to understand and apply the current provisions that NIST has put forth in recent reports FDA will integrate them into its regulatory oversight.

Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Can one software program defeat the performance capability or back up safety features of another software program? When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

These are the kinds of issues that will be highlighted during the webinar. The issues require careful consideration even though no obvious answer appears at hand.

Areas Covered in the Session:

FDA legal authority
FDA software guidance
Voluntary standards
National Institute of Science and Technology
Cybersecurity
Interoperability
Mobile Apps
Predictive analytics
Software validation
Software recalls

Who will benefit:

Regulatory Affairs
Quality Assurance
Software Design Engineers
Manufacturing
Complaint Dept.
Hospital Risk Dept.

Agenda:

Day 1 Schedule:

Lecture 1:

FDA authority and regulatory program

Types of Software are devices
Regulatory strategy
Risk classification
Function and outcome

Medical Device Data Systems (MDDS) Office of the National Coordinator (ONC) for Health Information Protection Software regulatory applications FDA Guidance

Premarket submissions
Paradigms: aeronautics

Quality System Regulation (QSR)

Design verification and validation
Voluntary standards
Corrective and Prevent Action Plans

Voluntary standards Recalls:

Service / maintenance / recall.
Implementation strategy

Corrections and Removals reporting Updates: FDA vs. non-FDA Predictive analytics

Lecture 2:

Interoperability

Compatibility by design
Hardware
Software

Labeling

Precautions
Instructions for use

Use of Voluntary Standards Proprietary information Failure management / follow up User's vs. manufacturer's legal responsibility

System configuration
Customization
Environment of use
Professional
Home use

Day 2 Schedule:

Lecture 1:

Cybersecurity

Device vulnerabilities: malfunction and failure
Pre-emption design
Latent malware/virus
Post-event management
Corrective action for software
Disclosure to users

National Institute of Science and Technology Report

Lecture 2:

Medical Mobile Applications (mobile apps)

Mobile apps defined as a device
FDA regulatory strategy
FDA guidance
National Institute of Science and Technology Report and Collaboration
Updates (FDA vs. non-FDA updates)
Criteria for corrective and preventive action deemed recalls
Reports of Corrections and Removals
Reports of adverse events

Professional vs. lay use / home use Labeling: instructions for use and precautions Environment of use FDA regulation of accessories Federal Communications Commission (FCC) regulation

Speaker:

Casper Uldriks

ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks, through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. As an investigator, he was responsible for countless 483s, scores of Warning Letters, injunctions, individual seizures, mass seizures and was coined by industry as FDA's "Darth Vader." He inspected foods, drugs, methadone clinics and clinical investigators, but specialized in the FDA's medical device program. He 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 for FDA. 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.

Location: Boston, MA Date: April 21st & 22nd 2016 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Boston Logan Airport

Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA

Price:

Price: $1,295.00 (Seminar for One Delegate)

Until March 10, Early Bird Price: $1,295.00 from March 11 to April 19, Regular Price: $1,495.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com