Preparing for a Health Canada Medical Device Establishment Licence (MDEL) Inspection Workshop

Register online  |  Download Registration Form (PDF)

Dates Available

April 26, 2019

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $685.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Abstract

This one day seminar will describe how Health Canada inspects licensed Medical Device Establishments. The regulatory requirements, audit preparation process, management of Health Canada documentation request, management of the audit process during the inspection and the process after the inspection will be explained.

Topics to be covered

This one day course will assist Companies with a Medical Device Establishment Licences (MDEL) to understand how to prepare for the inspection, and manage expectations both during and after the inspection.

The course details will include:

Overview of Health Canada’s regulatory requirements for Medical Device Establishment Licences

  • Device Licensing
  • Label review
  • Advertisement review
  • Additional documentation request (Procedures, Forms, Records)
  • Distribution Records
  • Recalls and Complaints
  • Clinical Testing and Special Access

Audit preparation before the Inspection

  • Review of previous Health Canada Audit Report and Response (if available)
  • Preparing the employees for the inspection
  • Conducting a Mock Inspection to identify potential Regulatory gaps

Notification by Health Canada of the inspection date

  • Responding to Health Canada Documentation Request

During the Inspection

  • Health Canada Inspection Opening Meeting
  • Facility Inspection and Tour
  • Managing the inspection process
  • Managing the Health Canada and Senior Management update meetings
  • Health Canada Closing meeting

After the inspection

  • Responding to the Health Canada Audit Report
  • Confirmation and follow up on Audit commitments (CAPAs, responsibilities and timelines)

Who should attend:

This training is applicable to Medical Device Class I Manufacturers, Importers of Class I-IV and Distributors of Class I-IV Medical Devices.

  • Quality Unit
  • Regulatory
  • Management
  • Materials Management
  • Procurement
  • Purchasing

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.

Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking (Please indicate any special Dietary requirements when registering for the course)

Note: Registration closes one week prior to the start of workshop.