FDA vs Health Canada
Duration : 75 Minutes
Rachelle D'Souza,
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national 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
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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.
Course Objectives:
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, labellers, 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.
Course Outline:
- 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
Target Audience:
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, labellers, 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
What do you get?
- Training Reference Materials
- Live Q&A Session with our Expert.
- Participation Certificate
- Access to SignUp Community (Optional)
- Reward Points
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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