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Current Health Canada Cannabis Act And Regulations, And Licensing Processes
Module 1
Cannabis Regulations- Overview – Current and Future
Current updates on the Cannabis Act and Regulations
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
Good Production Practices (GPP) And GxP For Cannabis
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 and Testing Requirements for Cannabis Production
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
Quality assurance training was very good with the content examples, how you stressing about the protocols of a QA person and what is expected. Seems to me that QA is always learning more information that is corrective and benefiticial. Year 2021.
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. Year 2019.
CEO at Professional Cannabis Consulting Inc.
I honestly think your staff did an amazing job as well as the extended classes shows your dedication to helping each student. Year 2018.
Facility management was an eye-opener of things like supply and demand, economy, and overall cost. The difference between things you want and the things you need. Year 2021.
Seeing how strict the regulations are within facilities is satisfying as a recreational consumer. Year 2021.
Helped reinforce concepts and helped me to visualize. It gave me a better idea of what to expect in the Cannabis Industry. Year 2019.
Quality Assurance Associate at Sevenleaf.ca
Excellent workshop! Please keep it up and come up with other important topics! Thank you! Year 2018.
The workshop is well organized, with ample amounts of information. Year 2018.
Learning where and what municipality you choose to operate in can have an outcome on success was good material to cover. Year 2021.
The information in this chapter was in-depth for anyone looking to become head of security or anyone looking to hire a competent person. Year 2021.
It was very useful and many information was covered during this training. Year 2020.
Quality Assurance Manager at ROSE LifeScience Inc.
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. Year 2019.
Quality Assurance Manager
Responsible person training was great, made me think of how important it is to be aware and responsible of things that are going on in the facility that you can improve on or prevent. Year 2021.
Thank you for nicely organized and presented materials. Year 2018.
Hearing all the requirements a responsible person has was eye-opening. Glad to had a walk-through on the process it would take to become one. Year 2021.
Great QA training program. Valuable Information. Year 2020.
Senior Account Manager at Isolocity
A lot of knowledge was provided and the book is a great reference to what I will need to re-read. Thank You! Year 2021.
I found it really that the technical writing was in particular adapted to the medical cannabis sector with appropriate assignments to enhance the learning experience . All the questions were answered in a very professional manner to give insight into processes applied to medicinal cannabis sector. Year 2018.
I learned a lot….Thanks! I had no idea how complex the cannabis business was. There are so many variables and it is obvious that we are in the early making of this business. This is great for NACPT! I look forward to making this business grow. Year 2018.
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. Year 2019.
Quality Assurance Specialist
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 Act and Regulations 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.
