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Health Canada’s Current Cannabis Regulatory Framework and Licensing Processes
Module 1
Cannabis Regulations- Overview – Current and Future
Recent and current updates on the cannabis regulations act
Regulatory Requirements for finished products, extracted oil, distillates, edibles and medical device
Module 2
Security Requirements
License security clearance processes (CTLS)
Module 3
Selling Regulatory Requirements
Environmental controls Regulatory Requirements
Packaging Regulatory Requirements
Labels Regulatory Requirements
Shipping Regulatory Requirements
Cannabis Regulations Requirements for Quality Assurance
Module 4
Cannabis Regulations and Act Overview
Developing LP application
Regulatory requirements
Document list
Compliance program
Case study
Q&A
Cannabis Good Production Practices (GPP)
Module 1
GPP – Cannabis Regulation Act, Part 5
Quality Assurance Systems for Cannabis
Module 2
Overview of GxP for Cannabis:
Good Production Practices (GPP)
Cannabis Eu-GMP
Good Agriculture and Collection Practices (GACP)
Good Manufacturing Practices (GMP)
Preventive Control Plans (PCP)
Hazard analysis and critical control points (HACCP)
Good Validation Practices (GVP)
Good Clinical Practices (GCP)
Good Laboratory Practices (GLP)
Good Documentation Practices (GDP)
Safe Food for Canadians Regulations (SFCR)
Module 3
Quality Management Systems
QMS Programs and Policies:
Control Procedures
Sanitation Program
Pest Management Program
Calibration Program
Validation Program
Training Program
Audit and Inspection Programs
Other QMS
Module 4
Good Production Practices (GPP) for Cannabis (GDocP)
GPP regulatory requirements and applications for:
Sales/exports
SOP
Building
Equipment
Filtration system
Sanitation Program
Cannabis Testing
Quality Assurance Person (QAP)
Module 5
EU-GMP – GPP Gap Analysis
Case studies
Sanitation Program for Cannabis Production and Testing Requirements
Module 1
Cannabis regulatory sanitation requirements
Expectation and current guidance
Objectives of Cleaning and Sanitation
Approved list of detergents and sanitizers
Module 2
Cleaning and Sanitation Program for production
Cleaning and Sanitation Procedure (SOP) for storage
Cleaning and Sanitation Procedure (SOP) for extraction
Module 3
Self-Inspection Procedure
leaning and Sanitation Records
Cleaning and Sanitation Verification
Module 4
Deviation, Out of Specification and CAPA
Training of personnel and record keeping
Cleaning validation requirements
Cleaning validation approaches for better performance
Module 5
Pest Control
Management
Case study
Analytical Testing Requirements
Biological Testing Requirements
Physical Testing Requirements
Stability Studies
Shelf-life establishments
Mandatory Testing Requirements
Non-mandatory Testing Requirements
Module 6
Testing Specification
Appropriate Testing Instrument and Software Systems
Certificate of Analysis
Method Development
Method Validation
Module 7
Out of Specification Result (OOS)
Out of Trent (OOT)
Outsourcing and Quality Standards
Training Requirements
Human Resources documents
Packaging, Labeling and Shipping
Case Study
Technical Writing and Establishment of Audit and Inspection Programs for Cannabis
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 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
“I am from the food industry. After this training, I have in-depth knowledge and the information needed for [a career in the] Cannabis Industry. I feel like I have been fulfilled with knowledge and understanding of the regulations, responsibilities I can bring to my work to deal with challenges. All is well.”
“I am absolutely honored to have been under your study. You have shown me what a graceful, knowledgeable, highly educated woman in a leadership role acts like. I cannot wait to continue my education with your business. Your integrity and the fact that you risked your reputation and career to help improve and set standards for the cannabis industry is astounding. Thank you”
“I worked in the pharmaceutical industry and I was looking for a career change in the cannabis industry. Excellent QA training and I appreciate the insightfulness of the requirements. Thank you, instructors, for sharing your “life experience” in the pharma/GMP/cannabis field. I truly admire your professionalism. Right after the completion of the QA training, I landed in a QA lead role in a leading cannabis company”
I got outstanding attention from NACPT. They are outstanding in helping students search for jobs, prepare a resume and interviews, personality development, etc. Teaching staff and administrative staff are friendly and very flexible, Year 2017.
“Helped reinforce concepts and helped me to visualize. It gave me a better idea of what to expect in the Cannabis Industry.”
Perfect place for study under the supervision of the director, her dedication in helping students with great knowledge and with excellent industrial networks are reaping success stories of NACPT students.. Wish this institute would help as many students as possible with their experienced staff, who are current professionals from Pharma industries. The director and her associates are fantastic and really helps students in difficult times.. Feeling happy for being a student here, Year 2016.
It was good! Year 2020.
Excellent Lectures. Excellent learning Programs, Year 2020.
Great workshop. Valuable Information. Year 2020.
It was very useful and many information was covered during this training. Year 2020.
Lecture was good, including the nutritive value of food, nutrition facts table and how it impacts on the treatment of diseases especially cannabis edibles for medical purposes. HACCP analysis was very good with details, overall. Year 2019.
The case studies and examples shared along with the dean’s much disciplined expertise really elevated our understanding of the quality control we need to be concerned about at every stage of the cannabis supply chain order to meet the highest international standards in a post-legalization world. A cross sectoral understanding of pharmaceutical and food service industries really enhanced the foundation of this course. Year 2019.
Useful to hear from experienced professionals and to validate the information currently understood. Year 2019.
Very good starting point for PCP. Year 2019.
This course was very useful in reassuring that all my studies have been correct along the line of following all aspects of GXP. Year 2020.
Thankyou for including the students in this session. It was extremely useful and insightful. It was a great overall summary of the details that I have learnt by attending the NACPT Industrial Cannabis Production Technology course which I am enjoying alot. I am planning to combine my training as a lawyer with the skills I am learning on the course to embark on a new exciting career. Thank You NACPT. Year 2020.
Thank you for the internship!
Kunal Sudan earned his BA from McMaster University and Graduate Certificate in Mental Health and Addictions from Ryerson University. Kunal has been training students and cannabis licensed producers in various topics in the cannabis industry since 2019 at NACPT Pharma College. He has a thorough knowledge of Health Canada’s Cannabis Regulations Act and all related regulations required in the cannabis industry. Kunal has more than six years of experience in the research and development field, especially within cannabinoid sciences. He spent several years educating both patients and clinicians, developed clinical trial applications, and has overseen patient care. Kunal has been actively participating in the Continuing Medical Education at the University of Toronto, Faculty of Medicine of Canadian Consortium on the Investigation of Cannabinoids. Students will enjoy his motivational training sessions at NACPT!
– B.Sc., Post Graduate Pharma QA & QC, MBA / TECH
Rathi Param is the president / founder of the 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.
