Industries: Pharma / BiotechSkin & Cosmetics

The Regulated Medical Marijuana Business - From Concept to Product Sale

Course Director: Richard Newmiller

Course Description - Course runs 9:00 - 5:00 both days (Breakfast & Lunch Included)

This two-day course consists of lectures and imbedded examples while encouraging direct interaction with the instructor.  Participants will receive a hard copy of the instructor’s class notes upon arrival.  The course is designed to educate the attendee by exposing them to the following topics.

  • The growing demand for medical marijuana
  • Federal versus State legislation
  • The governing regulatory agencies with direct impact
  • The major components of a business plan
  • Manufacturing planning from capacity scheduling to waste management control
  • Typical Standard Operating Procedures (SOPs) required
  • Quality functions such as release specifications, variances, deviations, retains, etc.
  • Space programming factors such as adjacencies, flows, pressurization, etc.
  • Site selection (community acceptance, utilities, labor rates, due diligence, etc.)
  • Project team member selection
  • Architectural design (floor plan, access, egress, finish schedules, etc.)
  • Mechanical design (room criteria, air flows, cooling & heating loads, filtration, etc.)
  • The major components of an HVAC system – energy saving enthalpy control
  • Electrical design (main service, back-up, lighting controls, load summary, etc.)
  • Comparison of grow lighting options
  • Security design (intrusion detection, surveillance, controlled access, product vault, etc.)
  • What constitutes preliminary, detailed, permitting & construction drawings
  • Identification of the licensing process and the required documentation
  • The value added functions of a construction manager who works for the owner
  • Commissioning & validation – protocol development and execution plan
  • Operations (vendor management, tracking, performance, contract lab, QA, etc.)
  • Staffing (job descriptions, policies, work rules, training, testing, etc.)
  • Approval inspection (compliance, master files, mock inspections, challenges, etc.)
  • Guidance (contracting options, scope and budget development, etc.)

Who Should Attend

This educational course is specifically designed to provide a comprehensive overview of the medical marijuana industry for growers, owners, designers, engineers, investors, regulators and lenders.  In addition, Quality, Validation, R&D, Clinical, Manufacturing, and Management personnel who are functioning as inspectors, auditors, investigators, operators, and end-users as well as those in project team or project management roles will benefit.

This two-day course will provide you with the subject matter needed to enhance your understanding of the industry by reviewing topics such as product demand, legalization, business and manufacturing plans, regulatory compliance, space programming, site selection, project team selection, architectural design, engineering, licensing, construction management, commissioning and validation, operations, and compliance/approval inspection.

Course Agenda

First Day

Introductions & Agenda Review

  • Growing demand and legalization
    • Controlled substance
    • Cannabinoids
    • Product descriptions
    • Legislation status maps (US states)
    • Qualifying conditions
    • Variations in medical marijuana programs
    • World map status
    • Market forecasts
    • Health effects of marijuana
  • Business plan
    • Define strategy and market
    • Select plant varieties
    • Distribution & POS method
    • Production forecast
    • Revenue forecast
    • Timeline
    • Risk analysis (demand, supply, regulation, operations, IP)
    • Funding, cash flow & ROI
    • Exit strategy
  • Manufacturing plan
    • Capacity & scrap
    • Sequencing
    • Cycle times
    • Yields
    • Photosynthesis, Respiration and CO2
    • Extraction process
    • Irrigation & fertilization
    • Diseases, infections, and pests
    • Filling & packaging
    • Security
    • Inventory tracking
  • Regulatory compliance
    • Embrace compliance
    • Local, regional and national regulations / authorities
    • Product release specifications
    • Contract lab selection and oversight
    • FDA clinical data and drug master files
    • Quality management systems (ISO, QA, QC)
    • Standard Operating Procedures (SOP)
    • Good agricultural practices (GAPs)
    • Pesticide dilemma
    • Odor control standards
  • Space programming
    • Design scope of work
    • Isolation goal
    • Functions
    • Square footage allocations
    • Head counts
    • Adjacencies
    • Flows (material and personnel)
    • Floor plan – first draft
    • Pressurization scheme
    • Detailed requirement analysis by room
  • Site selection
    • Green field, brown field, renovation, tenant fit-out
    • Local infrastructure – availability, capacity & rates
    • Zoning, use and building regulations
    • Geotechnical report
    • Environmental site assessment
    • Zoning maps
    • Condition inspection
    • Expansion option
    • Allowable drinking water contaminates

Second Day

  • Design & Engineering (licensed professionals)
    • Project Team
    • Professional services contracting options
    • Disciplines (licensed professionals)
    • Professional services cost ranges
    • Design sequence
    • Construction administration
    • Single Line Diagrams (electrical and HVAC)
    • Environmental conditions per growth stage
    • HVAC Diagrams and system types
    • Air filtration and odor control
    • Grow lighting options
    • Grow room design efficiency
  • Licensing
    • Patient-Focused Analysis
    • What to expect when applying
    • Applicant occupational and statutory requirements
    • Transactional relationships (dispensary, manufacturer, cultivator)
    • Identification of the review agencies
    • Application process steps; application and licensing fees
    • Required manufacturing documentation
    • Investigation and back-ground checks
    • Responsible personnel (duties & bio.)
    • Limitations: size, location, inventory, waste water, air
    • Significant method variation from state to state
  • Construction management
    • Project management triangle
    • Project execution comparison
    • Pre-construction services outline
    • Cost estimate classifications
    • Cost estimate variations
    • Cone of uncertainty
    • Construction services outline
    • Construction schedule variations
    • Estimating example
    • GC vs CM summary
  • Commissioning & Validation
    • Definitions
    • Confirms equipment selection & proper installation
    • Commissioning flow chart, critical team members
    • Industry guidelines
    • Commissioning checklist
    • Documentation matrix
    • Control parameters and calibration
    • Protocol development; IQ, OQ, PQ phases
    • Qualification report
    • Impact assessment; Boundary identification
    • Validation plan – a proposal for discussion
  • Operations
    • On-line position advertisement, job descriptions
    • HR functions and policies
    • Security, non-diversion, electronic systems
    • Energy, plug & cord equipment
    • Supply vendor management
    • Performance, maintenance, compliance reports
    • Trouble shooting
    • Inventory management
    • Tracking system
    • Quality assurance
    • Grow efficiency
    • Maintenance operations
    • Intellectual property (IP)
  • Compliance/approval inspection
    • Master documentation files with change control
    • Current SOPs
    • Training records
    • Mock inspections, rehearsed procedures, security challenges
    • Responding to observations (questions or judgements)
    • Compliance audit
  • Guidance; Q&A
    • Develop a written scope-of-work
    • If possible, employ one firm to design the facility
    • Try to minimize time and material contracts – employ fixed price or lump sum
    • Construction contracting options – GC vs CM
    • Scope, schedule, and cost estimate development
    • Total cash flow projections by period
    • Geographical (distance) management
    • Early termination of any team member who is dysfunctional, nonproductive, or a disturbance
    • Grow facility: pre-purchase inspection observations
  • Conclusion
    • Opinion: Regulation at the federal level is coming!
      • Product quality
      • Product safety
      • Interstate commerce
      • Banking
      • Tax revenues
      • Regional and Global competition
    • Comment: Use procedures and controls to manage your business (and not vice versa)
    • Use these notes as a path and a reference
    • Any additional questions?

Learning Objectives

Upon completion of this course, each participant will have an in-depth overview and understanding of the medical marijuana industry starting with the business concept and ending with product sale. Tools, methods and techniques will be employed throughout the course topics to help ensure the planning and execution process is completed in a timely manner while avoiding the typical pit falls that increase cost and extend schedules. Generally acceptable good manufacturing practices and good engineering practices will be integrated throughout the course to provide a robust and repeatable process for compliance with maximum uptime to enable a return on investment. Employee training, building system commissioning and validation, security, cleaning, sanitization and other Standard Operating Procedures (SOPs) will be introduced.