CANC14 & CANC06

Quality Assurance Person (QAP)

Quality-Assurance-for-Cannabis-Basic-and-Advanced

Live Session

Time: 9:30 AM – 4:30 PM
Duration: 4 Days
Level of Training: Intermediate | Expert
Mode of Delivery: Live, Interactive and Instructor-led Webinar
Fee: $3900

Both Online and OnCampus training is available

Take an Appointment with Program Advisor

Program Overview

The Quality Assurance for Cannabis certificate training program equips you with the technical knowledge and skills necessary to ensure that each cannabis product is safe and fit for sale or distribution in accordance with the Cannabis Act and Regulations. Our Quality Assurance for Cannabis training is recognized by industry leaders and regulatory bodies across Canada and around the world.

Training will allow you to develop Good Production Practices (GPP), Quality Assurance (QA) programs and Quality Management Systems (QMS), record keeping, complaint, recall, sanitation, audit and inspection, and quality control programs as well as implement written procedures for the approval or rejection of all products, specifications, representative sampling plans, test methods, controls, results that affect the purity, quality and the composition of cannabis products, and change control, CAPA and gap analysis technical components.

Attendees may interact with the class and lead trainers for more clarifications or concerns.

Program Offers

Register for 3 certificate programs at NACPT and get any available 1-day training for free.
Attendees will be issued the certificate of completion at the end of training program.

Additional Program Info

Program Module - Day 1
Program Module - Day 2
Program Module - Day 3
Program Module - Day 4
Learning Outcomes
Job Opportunities
Who Should Attend

Day 1

Program Module

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

Day 2

Program Module

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

Day 3

Program Module

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
Cleaning 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

Day 4

Program Module

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
CRA audit
Sample CRA audit walk through
Regulatory Inspections
COVID – Virtual Inspection
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

Learning Outcomes

Review of Cannabis Regulations Act for various applications and licensing processes
Meet Health Canada’s requirements of the Quality Assurance Person (QAP) and Quality Control (QC) Analyst in the Cannabis Industry
Apply GxP (GPP, Eu-GMP, GACP, HACCP, GDP, GVP, GEP, GLP, PCP and related good practices) system within the company
Understand and implement all necessary Quality Assurance Systems
Establish quality management systems and risk management within cannabis companies for better performance
Design self-inspection and regulatory inspection methods for cannabis operation
Develop current QA practices in cannabis companies
Review and approve CofAs
Develop cannabis technical procedures, policies, protocols and technical reports
Perform product annual reviews
Product/Batch release to the market
Dealing with customer complaints, recalls, return and destructions
Will have clear instructions and idea of QAP roles, QA and QMS systems and all regulatory requirements protocols

Job Opportunities

Quality Assurance Person (QAP)
Qualified Person in Charge (QPIC)
Greenhouse Manager
Master Grower (MG)
Responsible Person (RP)

Who Should Attend

Anyone who wants to learn about cannabis quality assurance systems
Quality Assurance Person (QAP)
Qualified Person in Charge (QPIC)
Processing Facility Manager
Greenhouse Manager
Master Grower (MG)
Responsible Person (RP)
Students & Graduates
Laid-off professionals
WISB, Second Career and OW clients

Faculty of Quality Assurance Person (QAP)

Dr. Tharshani Nishanthan

Regulatory and Quality Assurance, QAP

Dr. Tharshani Nishanthan is a highly skilled and accomplished professional with comprehensive expertise in quality assurance and regulatory affairs and a Ph.D. graduate from the University of Vermont, USA . She possesses a valid security clearance with Health Canada and is an approved Quality Assurance Person (QAP) under Cannabis Act/Cannabis Regulations.

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Kunal Sudan

CEO, Delta Eight Pharmaceuticals, Faculty Member of Industrial Cannabis Production Technology

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.

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Rathi Param

President / Founder & Dean

– 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.

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