ComplianceOnline

FDA vs Health Canada

Instructor: Rachelle D Souza
Product ID: 704862
Training Level: Basic to Intermediate
  • 16
  • January 2017
    Monday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 60 Min

Live Online Training
January 16, Monday 10:00 AM PST | 01:00 PM EST
Duration: 60 Min

$199.00
One Dial-in One Attendee
$399.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days after completion of Live training

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.

Why Should You Attend:

The Food and Drug Administration (FDA) and Health Canada are the regulatory authorities for USA & Canada respectively. If you are a manufacturer and want to launch or maintain your product on the North American market, be it a drug, medical device, dietary supplement, cosmetic or food, you need to ensure and maintain compliance with the regulatory requirements of these authorities. Regulatory compliance requirements also exist for other entities in the supply chain like packagers, labelers, lab testers, importers, distributors and wholesalers.

Attend this training for an understanding of the organizational hierarchy of FDA & Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.

Areas Covered in the Webinar:

  • FDA vs. Health Canada – Organizational Oversight for Different Product Types
  • FDA vs. Health Canada – Regulatory Submissions / Filings and / or Regulatory Processes for Different Product Types
  • FDA vs. Health Canada – Quality Systems & Establishment Licensing, Requirements for Supply Chain Entities
  • Examples of Consequences for Non-Compliance with Regulatory Authorities
  • FDA & Health Canada – Interactions & Potential Implications for industry

Who Will Benefit:

Professionals from Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic & Food Industries will benefit from this training. Start-ups, Virtually Run & Multi-national Manufacturers and other supply chain entities e.g. Importers, distributors, packagers, labelers, testers, wholesalers will also benefit. People in the following job functions, will benefit from this session:

  • Manufacturing
  • Supply chain
  • Quality control
  • Quality assurance
  • Regulatory affairs
  • Compliance
  • Documentation
  • Audit
Instructor Profile:
Rachelle D Souza

Rachelle D Souza
CEO and President, Regulatory Heights Inc

Rachelle D’Souza, CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities / agencies for multinational and start-up companies.

Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety / pharmacovigilance and medical information systems.

At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.

Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets.

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