Complaint and Recalls for Cannabis

Course Overview

A poorly implemented complaint and adverse reaction handling process poses both regulatory compliance and business risks to an organization. Many corporate reputations have been compromised or tainted as a result of their inability to determine “root cause” and take timely, effective action when a problem comes.

During this course, you will learn all relevant aspects to efficiently organise and improve your complaint Handling and Recall and Adverse Reaction System to fulfil current Cannabis Regulations requirements.

In principle, every complaint or adverse reaction might cause a recall, and every complaint may provide an opportunity to improve. According to the Cannabis Regulations, the Licensed Producer must review all complaints and other information concerning potentially defective product carefully according to written procedures. Additionally a system should be designed to investigate the need and initiate (if necessary) the recall. According to the Cannabis Regulations, Licensed producer should have a designated person responsible for handling the complaints and deciding the measures to be taken. The Quality Assurance (QA) should be made aware of any complaint, and be actively involved in the investigation and any subsequent recall.

Course Outline

• Review of the Cannabis Regulations
• Complaint Handling System Essentials
  • Characterizing complaints and conducting investigations
  • Risk management and determining the necessary actions:
  • Data handling and trending
  • Implementing corrective actions
  • Failure analysis and establishing preventative actions
  • Follow-up and closure
  • Standard Operating Procedure(SOP)
• Organizational and functional responsibilities of Quality Assurance Person (QAP) and Responsible Person
• Documentation and Record Keeping Requirements
• Customer response letters
• Critical linkages with Adverse Event Reporting System
• Adverse Events Reporting Regulatory Requirements
• Classification of reportable incidents
• Reporting requirements:
• Documentation
• Compliance Enforcements
• Effective Recall Management
• Events that can lead to a recall (e.g. Out of Specification, Complaints, etc)
• Purpose of a recall
• Cannabis Regulations requirements
• Recall Process
  • Roles and responsibilities
  • Investigation
  • Risk assessment and strategy
  • Effective communication
  • Market withdrawal
• Recall Closure
  • Product reconciliation
  • Recall effectiveness check
  • Preparing the final report