Health Canada Guide-0069 - Regulatory Provisions

• Review guidelines for products in transit: stability data requirements and temperature mapping
• Discuss the regulatory scope of temperature monitoring for CRT Hear recommended approaches for risk evaluation and mitigation and analyze examples of compliance and non-compliance
• Take a look at what Roche implement locally to distribute to our Canadian customers to fulfill the authority requirements

Presentation by Tonino Antonetti Executive Director, Regulatory Affairs, Quality Management, Safety & Health and Environment Roche Diagnostics Canada