Module I(a) Description:

A timely, fast and successful application process is the beginning of many product success stories in Canada.  Module I(a) covers:

• Management of Applications
• Process Overview and Target Times
• Class II Requirements
• Class III & IV General Requirements
• Administrative Processing and Application Validation
• Quality Issues addressed with Clarifaxes
• Application Screening Quality Issues addressed with Screen Deficiency Letters, Class II, III & IV

Module I(b) Description

• Use of STED documents in the application process (medical devices, non-IVD)

Each webcast is approximately 1.5 hours in length.

Speakers:

All presenters are from Health Canada's Medical Device Bureau.

Module I(a) speaker is Sarah Chandler from the Device Licensing Service Division.

Who should attend?

• Regulatory Affairs Associates of all levels
• Quality Assurance Managers / Associates
• Research & Development Managers / Associates

Registration Information:

MEDEC Members:  $50 plus tax

Non-MEDEC Members:  $75 plus tax 

NOTE:  It will be about 24 hours from the time you register to the time you receive the connection information.

Cancellation Policy: Cancellations must be received in writing 10 business days prior to the date of the webcast to qualify for a refund. Substitutions are permitted. Failure to show will result in full fee charge. Payment must be received prior to the start of the webcast. Registrations become effective only when payment has been received by MEDEC.