FDA vs Health Canada

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, 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.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-and-health-canada-comparison-of-regulations-and-oversight-webinar-training-704862-prdw?channel=sciencedz