IN-VITRO DIAGNOSTICS

Conference Date: 27 Apr 2010
Conference Ref: N4-8210
Fee: £440 + VAT
Venue: MWB Cavendish Square, London, W1

 Supported by BSi

Following the success of our Medical Device Training Academy series: Medical Device Training days in 2009, we are once again providing a series of events under the Academy.

Course Summary

This course will clarify the requirements applicable for IVDs and will highlight the important issues regarding supplier control and validation. Practical workshop exercises throughout the day will help consolidate the information provided.

Key Topics to Include:

• Introduction to the IVD Directive
• What is and What is Not an IVD
• Exercise
• Comparison with the MDD
• Future Changes to the IVDD
• Conformity with the Essential Requirements
• Risk Management
• Exercise
• IVD Hot topics
• – Supplier control
• – Validation
• Exercise
• Vigilance and Post Market Surveillance
• Exercise
• Wrap Up

Who Should Attend:

• Regulatory Affairs Personnel
• Quality Assurance Professionals
• Those responsible for Original Equipment Manufacturer (OEM)/Subcontractor control of IVDs

Tutor:
Sue Spencer, Head IVD, Healthcare, BSi

Please note,The Cavendish Hotel, which is the recommended accommodation for this event, is a 15-20 minute walk from the MWB Cavendish Square venue.

Click here to register for this important Seminar.