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Both Online and OnCampus training is available
*Recorded Program: (Duration: 8 Hours, Fee: $895)
Performing self-inspection is a critical element of a Quality Management System (QMS). Preparing for regulatory inspection with appropriate technical document creation will help licensed producers produce cannabis products as per Health Canada’s regulatory standards.
This program will cover the regulatory inspection and its various types, Good Documentation Practices, cannabis technical writing, QIR, QDR, risk management in cannabis, and GAP analysis through real case studies.
Attendees may interact with the class and lead trainers for more clarifications or concerns.
Module 1
Cannabis Current Audit and Inspection
Audits (internal and external)
Self-inspection programs for process improvements
Regulatory Inspections
Types of Inspections
Preparing for inspections
Outcome of inspections
Corrective and preventive actions
Responding to Inspection Comments
Case Study – Create Template
Questions and Answers
Module 2
Cannabis Technical Writing – Part 11
Good Documentation Practices (GDP)
Training Requirements
Technical Writing for the Cannabis Industry
Quality Incident Reports (QIR)
Quality Deviation Reports (QDR)
Planned Deviation
Unplanned Deviation
Standard Operating Procedure
Protocols/Reports
Template creation
Module 3
CAPA and Gap Analysis – Part 2
Corrective and Preventive Actions
Risk management
Data handling and trending
Implementing corrective actions
Establishing preventative actions
Gap Analysis
How to perform gap analysis
Process maps
Complaint Procedures
Annual reviews
Data handling and trending
Retained Samples
Adverse Reactions
Recalls/Returns/re-processing
Module 4
Change Control and Related Topics- QA – Part 3
Change Control Process
Case Study
Evaluation Review
– B.Sc., Post Graduate Pharma QA & QC, MBA / TECH
Rathi Param is the president/founder of NACPT Pharma College, International Medical Cannabis Association (IMCA), and Validation Tech Inc. Rathi earned her B.Sc. in Chemistry from University Ottawa, MBA in Technology from the University of Phoenix and Post Graduate Pharmaceutical QA & QC Certification from SRN Institute. She is an innovative and creative leader with more than twenty years of hands-on experience in many scientific industries (medical cannabis, medical devices, environmental, food, pharmaceutical and bio-pharmaceutical), complemented with fifteen years of academic and corporate training experience. She possesses extensive expertise and knowledge of Quality Control, Quality Assurance, Formulation, Validation, Technology Transfer, Manufacturing Technology, Process Improvements, Auditing, and Inspection.
Juliet Nagudi
Graduate from Effective Technical Writing for Medical Cannabis Sector
The training you provided exceeded my expectations. It assures you and my continued relationship and further training with you. Thank you. Year 2018.
