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
Past Events
US FDA Quality Systems & Medical Device Requirements - 10-11 Dec 2009, The Rembrandt Hotel, London, United Kingdom (1525)
Important
Please, check "US FDA Quality Systems & Medical Device Requirements" official website for possible changes, before making any traveling arrangements
