Seminar on US Medical Device Regulation at San Diego, CA

Course "US Medical Device Regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
• Break Overnight
• Clinical Trials
o IDE
o Other
o Export for trials
o Common problems in trial design and management
• Post marketing
o QSR
o CAPA
o Reporting
o Inspections
o Export for foreign markets
• Pop quiz
o Give quiz
o Discuss questions and answers
Why should you attend?
Have you had the experience of guiding a new product through concept, development, and final design, and, while you are preparing the product for US introduction, you suddenly stop dead. It seems FDA has decided your product is a medical device!
The basic definition of a medical device is extremely broad, including "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is...intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease..." If the product’s intended us has some relationship to health, and the product is not a drug, it's possible to define it as Medical Device. Fortunately for publishers, medical textbooks and medical journals have not yet been considered to be medical devices. What has been determined to be medical devices by FDA are laboratory developed tests, and stand-alone software that keeps track of patient's condition, that is, LIMS and Electronic Health Records. If you are developing, or considering developing, or considering financing development, you need to have some basic understanding of US medical device law, and this 1.5 day session is designed to give you that.
Who will benefit:
• People who are Working in non-Regulatory or QA Areas of Medical Device Companies
• People who are Interested in Starting a Company to Sell Health-related Products
• People who are Interested in financing a Health Care Company
• People who are Interested in Selling Medical Devices
Agenda:
Day 1 Schedule:
Lecture 1: What is a device?
• How can you tell if your product is a medical device
• Regulation and guidance and the role of each
• Determining your classification
Lecture 2: Pre-market
• Design control
• Pre-submission meetings
Lecture 3: Marketing submissions
• PMA
• 510(k)
• De novo
Lecture 4: The "different" products
• Combination Products
• IVDs and LDTs
• Software
Day 2 Schedule:
Lecture 1: Clinical Trials
• IDE
• Other
• Export for trials
• Common problems in trial design and management

Lecture 2: Post marketing
• QSR
• CAPA
• Reporting
• Inspections
• Export for foreign markets
Lecture 3: Pop quiz
• Give quiz
• Discuss questions and answers

Location: San Diego, CA Date: December 17th & 18th, 2015 Time: 9 AM to 6 PM

Venue: Four Points By Sheraton San Diego Downtown
Venue Address: 1617 1st Avenue - San Diego, California, 92101 - United States

Price: $1,295.00 (Seminar for One Delegate)
Register now and save $200.
Until November 20, Early Bird Price: $1,295.00

From November 21 to December 15, Regular Price: $1,495.00

Registration Details:
NetZealous LLC - DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
USA Phone: 1-800-447-9407
Fax: 302-288-6884
support@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/1PR5s2D