2-day In-person Seminar on Compliance Software Solutions for Medical Devices at Singapore

Event Details

Time: September 28, 2015 at 9am to September 29, 2015 at 6pm
Location: Mandarin Orchard Singapore
Street: 333 Orchard Road, Singapore 238867
City/Town: Singapore
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: John Robinson
Latest Activity: Aug 4, 2015

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Event Description

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.

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.

Speaker:

Casper 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.

Location: Singapore Date: September 28th & 29th, 2015 Time: 9:00 AM - 6:00 PM
Venue: Mandarin Orchard Singapore

Venue Address: 333 Orchard Road, Singapore 238867

Price: $2,095.00 (Seminar for One Delegate)

Until August 15, Early Bird Price: $2,095.00

From August 16 to September 26, Regular Price: $2,295.00

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone: 800-447-9407

Fax: 302-288-6884