Applying U.S. FDA Laws and Regulations 2017

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.

Areas Covered in the Session:

• An Overview of U.S. FDA Regulation for Medical Devices
• Quality System Regulation 21 CFR 820: Current GMP for Medical devices
• Premarket Notification - 510(k) and Premarket Approval (PMA)
• Post Market Reporting Requirements
• FDA Facility Inspection

Who will benefit:

• Regulatory Affairs - VP, Director and Managers
• Regulatory Affairs - Associates and Specialists
• Compliance Officers
• Research & Development - Product Managers
• Quality Assurance and Quality Engineers

Location: SFO, CA Date: March 2nd & 3rd, 2017 and Time: 08:30 AM to 5:00 PM

Venue: DoubleTree by Hilton Hotel San Francisco Airport

Address: 835 Airport Blvd., Burlingame CA 94010-9949

Price:

Price: $1,295.00

Until January 20, Early Bird Price: $1,295.00 From January 21 to February 28, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00       $6,475.00 You Save: $2,590.00 (40%)*

Until January 20, Early Bird Price: $1,295.00 from January 21 to February 28, Regular Price: $1,495.00

Register now and save $200. (Early Bird)

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com