US FDA QUALITY
SYSTEMS &
MEDICAL DEVICE
REQUIREMENTS

Conference Date: 10 Dec 2009-15 Jan 2010
Conference Ref: N12-8109
Fee: £1180 + VAT
Venue: The Rembrandt Hotel, London

Benefits in attending:

• Understand the US FDA Medical Device Quality System Regulation 21 CFR Part 820
• Learn How to Successfully Apply the Regulations
• Discover the Emphasis on FDA’s Current Areas of Focus and How it Could Impact on Your Company
• Gain a Comprehensive Understanding of:                
   - Management Controls
   - Design Controls
   - Production and Process Controls
   - Corrective and Preventative Action (CAPA)
  Plan How to Align US FDA Quality System Requirements with ISO 14971 Risk Management
• Be Prepared for US FDA Inspections
• Know How to Respond to FDA 483s and Warning Letters
• Take Away the Elements of an Effective CAPA Process
• Understand Complaint Handling, Vigilance and Post Market Surveillance

To book your place, please click here.