Medical Device Quality & Regulatory Requirements for Importer/Distributor and Manufacturers – Canadian Market
A ONE DAY COMPREHENSIVE & INTERACTIVE COURSE
Receive a Credit toward the Diploma program in Pharmaceutical Quality Control & Quality Assurance
Distinguished Faculty
Mia Spiegelman, B.Sc., RAQC
National Regulatory Affairs and Quality Assurance Director
Cardinal Health Canada
Mia Spiegelman was educated in Israel, Argentina and Toronto and holds a B.Sc. in Chemistry from York University and a Post Degree Certification if Pharmaceutical Regulatory Affairs and Quality Assurance from Seneca College. She brings to the table 9 years of experience in Generic Drugs, Medical Devices, Cosmetics and Natural Health Products. She has worked in various companies and has dealt with various product lines such as endoscopes, Dialysis Machines, Importation and distribution of all classed of regulated products as well Service Departments for the Medical field. Currently, she is a National Director for RA/QA in Canada’s leading and only national full service and value add distributor for Medical, Surgical and laboratory products – Cardinal Health Canada.
Registration Fee Includes
Presentation Materials, Luncheon, Refreshment and Free Parking
Note: Please indicate any special Dietary requirements when registering for the course
Dates Available
March 7, 2012
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 intensive one-day comprehensive course, provides participants with a solid understanding of the principles behind the Medical Device Regulations and how to apply them to your company’s current processes and procedures. The course starts with a detailed overview of Medical Device Regulations and the requirements of Establishment which wishes to import / Distribute / Manufacture these medical products. Different business scenarios will b e highlighted such as Manufacturing, Importation, Distribution, Private labelling and even servicing will be touched upon. The course shares experiences from real life scenarios of companies wishing to handled Medical devices in the Canadian market and “Lessons learned” as well as “show-stopper” situations.
Course Outline
- INTRODUCTION – Medical Device Regulations Explained
- Classes of Devices
- Establishment Licence Requirements
- Risk based classification
- Labelling requirements
- IVDDs
- Custom Devices
- Recalls
- Mandatory Problem Reporting
- Record Retention
- Software considerations
- Nne-Medical Device Regulations Mandatory considerations for the Canadian Market:
- MSDS
- Canadian Electircal Approval
- TDG
- Temperature considerations
- Latex / BPA / DEHP Content
- Expiry
- Sterility
- ISO 13485 – Brief description of when you would need this and what does it entail
- Considerations on voluntary vs Mandatory ISO implementation and Registration
- The “Growing pain” – lessons learned
- Timelines and show stoppers
- What about Service?
- Business Scenarios – Considerations to be made if you are or with so be:
- International Manufacturer selling into the Canadian Market
- National Manufacturer selling into the Canadian Market
- Importer into Canada
- Distributor in Canada
- Manufacturer / Importer Combination
- Manufacturer Distributor Combination
- Provide Service or Installation of your equipment
- Have a Private Label agreement with a third Party Manufactuere
Who Should Attend
This One-day course is applicable to Personnel from the following areas:
- Quality Assurance
- Validation
- Quality Control Laboratory
- Regulatory Affairs
- Analytical Laboratory
- Training
- Contract Laboratory
- Consultants
- Manufacturing
- Packaging and Labeling
- Distributers and Wholesalers
- Importers
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.