Medical Device Quality and Regulatory Requirements for Importer/Distributor and Manufacturers – Canadian Market Workshop
April 15, 2019
9:00 a.m – 5:00 p.m.
CAD $685.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Dr. Chaitanya Baliga has over twenty years of Quality Assurance, Regulatory and Compliance experience in manufacturing, pharmaceutical, medical devices, toy, food, drug, cosmetics, natural health products and other consumer / service industries in Canada and other parts of the world.
Chaitanya has a strong understanding of regulations that pertains to Health Canada, FDA, ICH, EU MDD, ANVISA, CSA/UL, and ISO 13485/14971. Chaitanya has successfully developed process improvement / operational excellence/ regulatory compliance / licensing and auditing/inspection training programs in pharmaceutical, medical device and other regulated industries. He is technical committee member for medical devices quality management systems standards.
Chaitanya holds a Ph.D. in Materials Science from University of Surrey, UK. In addition, he holds ASQ certifications for Quality Auditor (CQA), Six Sigma Green Belt (CSSGB), and Manager of Quality/Organizational Excellence (CMQ/OE).
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 labeling 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.
- INTRODUCTION – Medical Device Regulations Explained
- Classes of Devices
- Establishment Licence Requirements
- Risk based classification
- Labelling requirements
- Custom Devices
- Mandatory Problem Reporting
- Record Retention
- Software considerations
- Nne-Medical Device Regulations Mandatory considerations for the Canadian Market:
- Canadian Electrical Approval
- Temperature considerations
- Latex / BPA / DEHP Content
- 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
- Quality Control Laboratory
- Regulatory Affairs
- Analytical Laboratory
- Contract Laboratory
- Packaging and Labeling
- Distributers and Wholesalers
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.