Key Benefits

By participating, you will learn:

• Secrets to success for incorporating design controls into a fast and flexible development process

• Keys to streamlining verification practices

• Strategies for efficient and effective implementation of product safety controls

• Prudent document retention and communication management

• Learning from "closed" claims

• How to view risk management as everyone's job

• Improving communication between mid and executive management

• Understand CAPA Connector (only section that specifically requires feedback to management)

• Find out what to keep your eyes one with regard to Management Responsibility for QA

• Understand the conversion of the compliance perspective to the management perspective

• Insight into the role of the management representative

• How to prepare and conduct an FDA inspection

• Hear case studies – lessons learned and experiences in FDA inspections

• How to best prepare site, systems and staff for inspection

• Gain perspective on inspection in U.S. and outside the U.S.

• Develop Manageable CAPA Systems

• Successfully Manage Field Corrective Actions

• Create Highly Effective Risk Management Systems

• Understand the links between ISO 13485:2003, FDA’s Quality System Regulation, Europe’s CE Marking Requirements and Canada’s Medical Devices Regulations

• Gain insight into FDA’s inspection authority and how to respond to troublesome requests

• Learn the Perspective of Notified Body for CE Mark Directive 93/42/EEC and Third Party Audit (Inspection) Process