Seminar on Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC) at Philadelphia, PA

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:

• Total Product Life Cycle and Your Medical Device
• An Overview of U.S. FDA Medical Device Regulation
• Regulations for Design and Product Development
• Premarket Notification - 510(k) and Premarket Approval (PMA)
• Regulations for Production & Process Control
• Readiness for FDA Facility Inspection

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:

Subhash R Patel

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