The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: February 11, 2016 at 9am to February 12, 2016 at 6pm
Location: Hilton Garden Inn Philadelphia Center City
Street: 1100 Arch St
City/Town: Philadelphia
Website or Map: http://bit.ly/Applying-US-FDA…
Phone: 18004479407
Event Type: conference
Organized By: John Robinson
Latest Activity: Dec 17, 2015
Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 days, the following essential topics will be covered:
Why should you attend?
The complex network of multilayer laws, regulations and regulatory requirements create confusion and misinterpretation that leads the device manufacturer into Non-compliance state. Non-compliance to applicable laws and regulations results into severe penalties or regulatory actions form U.S. FDA that could damage image and position of the company. To avoid such undesired circumstances, it is important to see a big picture of TPLC and all applicable U.S. FDA laws and regulation at each phase of their own product life cycle.
Agenda:
Day 1 Schedule:
Lecture 1:
Total Product Life Cycle and Your Medical Device
Lecture 2:
An Overview of U.S. FDA Medical Device Regulation - Part 1
Lecture 3:
An Overview of U.S. FDA Medical Device Regulation - Part 2
Lecture 4:
Regulations for Design and Product Development
Day 2 Schedule:
Lecture 1:
Premarket Notification - 510(k) and Premarket Approval (PMA)
Lecture 2:
Regulations for Production & Process Control - Part 1
Lecture 3:
Regulations for Production & Process Control - Part 2
Lecture 4:
Readiness for FDA Facility Inspection
Speaker:
Location: Philadelphia, PA Date: February 11th & 12th 2016 and Time: 08:30 AM to 5:00 PM
Venue: Hilton Garden Inn Philadelphia Center City
Address: 1100 Arch St, Philadelphia, PA 19107, United States
Price:
Register now and save $200. (Early Bird)
Until January 15, Early Bird Price: $1,295.00 from January 16 to February 09, 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
Registration Link - http://bit.ly/Applying-US-FDA-Laws-and-Regulations
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