After obtaining a grower license, licensees must focus on regulatory compliance to maintain their license. Licenses must be renewed annually, which requires proving ongoing eligibility. Regulations include detailed reporting requirements for any changes, extensive recordkeeping, and allowing inspections. Non-compliance can result in fines or license suspension. Licensees must anticipate delays and uncertainty as the new industry develops. Maintaining compliance with all laws, rules and regulations is essential to the long-term success of a cannabis business.
Providing SharePoint Solutions in an FDA Regulated EnvironmentDeb Walther
This talk explains to the IT Professional the reasons behind the FDA regulations and what must be considered when implementing SharePoint in a GxP environment.
This breakfast club focused on the new Data Protection regime covering what the new regime will entail and what to be thinking about now in order to be ready for the new regulations.
https://www.brownejacobson.com/sectors-and-services/sectors/public-sector
Devices Sponsor Information Day: 5 - Post-market - Recalls and non-recall act...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
This presentation covers the basics of federal grant accounting and compliance (and why you need to know it), state and local tax and corporate tax issues (even if you're not generating revenue), R&D credits, and more for biotech companies.
Presentation to Ukraine Commodity Market Development Conference
The author of the presentation: Christa Lachenmayr, Division of Market Oversight, CFTC (US)
Providing SharePoint Solutions in an FDA Regulated EnvironmentDeb Walther
This talk explains to the IT Professional the reasons behind the FDA regulations and what must be considered when implementing SharePoint in a GxP environment.
This breakfast club focused on the new Data Protection regime covering what the new regime will entail and what to be thinking about now in order to be ready for the new regulations.
https://www.brownejacobson.com/sectors-and-services/sectors/public-sector
Devices Sponsor Information Day: 5 - Post-market - Recalls and non-recall act...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
This presentation covers the basics of federal grant accounting and compliance (and why you need to know it), state and local tax and corporate tax issues (even if you're not generating revenue), R&D credits, and more for biotech companies.
Presentation to Ukraine Commodity Market Development Conference
The author of the presentation: Christa Lachenmayr, Division of Market Oversight, CFTC (US)
Commercial Property Due Diligence - a Lawyer's Practical GuideTom Meagher
In this we cover: Certificates of Title, Restrictions on Sale, Leases, Management & Maintenance, Physical aspects of the Property, Planning, Licensing & Environment and other related due diligence considerations
In order to safely navigate these tricky waters, it is best to be prepared ahead of time, so that potential hazards and serious issues can be averted. By knowing what to expect and when to execute, your deals will not only close, but move forward more smoothly.
In this webinar, we will review the background and current landscape for deals, including leading deal transaction vehicles, and federal and state requirements. We will then discuss some of the more common compliance requirements, and the issues and challenges associated with them so that attendees may learn best practices in improving the efficiency and transparency of deal workflow.
HIPAA in 2023: Changes, Updates, and Best PracticesConference Panel
HIPAA 2023 Guidance and Compliance refers to the latest regulations and guidelines for protecting patient privacy in healthcare. Healthcare organizations need to stay current on the rules and guidelines related to privacy, security, and breach notification. This includes understanding the key changes to HIPAA regulations, ensuring compliance for covered entities and business associates, implementing best practices for maintaining HIPAA compliance, and addressing the impact of technology and innovation on healthcare privacy and security. Training, risk assessments, audits, and patient rights are also essential aspects of HIPAA compliance.
Register for the HIPAA 2023 Guidance and Compliance Webinar,
https://conferencepanel.com/conference/hipaa-2023-latest-guidance-and-compliance-focus
Tellefsen and Exactpro Systems Team Up to Help Clients with REG SCI
Meeting the demanding new requirements imposed upon firms by SEC Regulation SCI
is a key issue for many firms, especially in the areas of independent systems testing
and certification. Tellefsen and Company, L.L.C. (Tellefsen) and Exactpro Systems,
LLC (Exactpro) have today announced a marketing partnership in which both firms will
collaborate to provide key industry constituents with market structure consulting, financial
technology infrastructure testing and software quality assurance testing services.
Tellefsen is a management consulting firm founded in 1984 to provide counsel and
professional services to meet the growing needs of the financial services industry. The
firm’s principals and consultants have a wealth of experience in regulatory compliance
and U.S. market infrastructure (exchanges, ATS, dark pools etc). One of Tellefsen’s core
competencies has been is assisting firms with their regulatory compliance requirements
through technology analysis, planning, testing, and evidencing.
Exactpro is a rapidly growing quality assurance services firm specializing in market
infrastructure. Exactpro provides both functional and non-functional testing for global
exchanges, dark pools and clearing houses using a range of sophisticated in-house built
testing and evidencing tools.
John Rapa, President and CEO of Tellefsen, indicates: “The implementation of Reg SCI
is another example of market regulations where market participants must provide evidence
of their comprehensive infrastructure testing, policies and procedures and market oversight
compliance. We are delighted to team up with Exactpro whom we know from other customer
engagements. We are very impressed by their capabilities, diligence and effectiveness in
planning, executing and evidencing tests that prove regulatory compliance”.
Iosif Itkin, Co-Founder of Exactpro, says: “Our firm has a great set of tools and services that
we believe can help clients meet Regulation SCI in a cost effective manner. We are very
conversant with this domain and are delighted to be working with Tellefsen on this; our two
firms’ capabilities are entirely complementary”.
Regulations Impacting Public Refrigerated WarehousesAngela Carver
The government and government regulatory agencies impose guidelines upon supply chain service providers such as public refrigerated warehouses because they have significant impact on product quality and safety as they are typically the last to handle and/or process the inventory before reaching consumers. Because of this direct connection to consumers, product safety is a critical element.
In many cases, cold storage supply chain service providers must quickly adapt their businesses to meet regulatory guidelines regardless of cost to avoid stiff penalties or shut downs. Some of the most recent regulations impacting temperature controlled facilities include the Food Safety Modernization Act (FSMA), the Sanitary Transport Rule, FDA Title 21 CFR Part 11 and the Drug Quality Security Act (DQSA). Each of these affect operations in a unique way and pose a different set of challenges for each PRW.
The FSMA was signed into law by the Obama administration as part of a movement to increase food safety. In this regulation, the FDA is granted additional power through these provisions: expanded administrative detention, records inspection, authority to deny entry, suspension registration and mandatory recall. This was done in hopes of reducing or eliminating the 48 million foodborne illnesses reported each year.
The sanitary transport rule, as part of the FSMA, is an additional safeguard added to prevent transportation practices that may negatively impact food safety. This new rule applies to shippers, receivers and carriers transporting both human and animal food products within or into the US. Shippers hired by PRWs now must follow strict vehicle maintenance guidelines, operational procedures, data exchange, training protocols and record maintenance.
Another regulation impacting public refrigerated warehouses is FDA Title 21 CFR Part 11. This regulation was initially drafted in 1997 and has been subsequently updated to accommodate new and updated technology. This law regulated what type of electronic signature is acceptable and in what cases electronic signatures are considered valid. This helps to streamline audits, system validations and audit trails required by the FDA.
Lastly, for those PRWs handling pharmaceutical inventory, DQSA designates what inventory and transaction data must be saved and available for FDA if requested. This regulation impacts manufacturers, re-packagers, wholesale distributors, 3PLs and dispensers. Under DQSA, businesses must record transaction information, history and statements.
To learn more about regulations impacting public refrigerated warehouses contact Datex cold storage experts today at www.datexcorp.com , marketing@datexcorp.com or 800.933.2839 ext 243.
This presentation provides an overview of the major provisions proposed by the EPA in the new hazardous waste generator improvements rule. It outlines the four primary issues that exist with today's regulations and how some of the more significant proposals seeks to address those issues. Find out about the rule process and schedule and what this means for hazardous waste generators.
Regulatory 101 for Medical Device Start UpsEMMAIntl
In this webinar hosted from EMMA International's Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and device listings.
FLIR Consent Agreement Analysis - Part 1Matt Henson
This presentation discusses the FLIR Consent Agreement, which stemmed from violations of the International Traffic in Arms Regulations (ITAR). The presentation focuses on what went wrong (the Proposed Charging Letter) and touches on the mandatory requirements (Consent Agreement). This is Part 1 in a multi-part series.
TGA Presentation: GMP Clearance Information Session,5-7 September 2017TGA Australia
Provides an overview of the improvements made to the GMP clearance process including the revised guidance, the introduction of an application assistance tool, the redesigned application e-forms and the compliance verification process.
Calgary Oil & Gas Regulatory and Standards Day January 18th 2023Nimonik
On 18th January 2023, Nimonik Inc. hosted the inaugural “Calgary Oil & Gas Regulatory and Standards Compliance Day”. During the event, we covered newly published topics, upcoming regulatory changes for the oil & gas industry, and best practices for compliance management. The event attendees also had the opportunity to connect with industry peers and share compliance challenges.
How to Get Your Recreational (Adult-Use) License and Overcome Roadblocks with...Cannabis Legal Group
How to Get Your Recreational (Adult-Use) License and Overcome Roadblocks with your Municipality by Barton Morris, Principal Attorney Cannabis Legal Group
Commercial Property Due Diligence - a Lawyer's Practical GuideTom Meagher
In this we cover: Certificates of Title, Restrictions on Sale, Leases, Management & Maintenance, Physical aspects of the Property, Planning, Licensing & Environment and other related due diligence considerations
In order to safely navigate these tricky waters, it is best to be prepared ahead of time, so that potential hazards and serious issues can be averted. By knowing what to expect and when to execute, your deals will not only close, but move forward more smoothly.
In this webinar, we will review the background and current landscape for deals, including leading deal transaction vehicles, and federal and state requirements. We will then discuss some of the more common compliance requirements, and the issues and challenges associated with them so that attendees may learn best practices in improving the efficiency and transparency of deal workflow.
HIPAA in 2023: Changes, Updates, and Best PracticesConference Panel
HIPAA 2023 Guidance and Compliance refers to the latest regulations and guidelines for protecting patient privacy in healthcare. Healthcare organizations need to stay current on the rules and guidelines related to privacy, security, and breach notification. This includes understanding the key changes to HIPAA regulations, ensuring compliance for covered entities and business associates, implementing best practices for maintaining HIPAA compliance, and addressing the impact of technology and innovation on healthcare privacy and security. Training, risk assessments, audits, and patient rights are also essential aspects of HIPAA compliance.
Register for the HIPAA 2023 Guidance and Compliance Webinar,
https://conferencepanel.com/conference/hipaa-2023-latest-guidance-and-compliance-focus
Tellefsen and Exactpro Systems Team Up to Help Clients with REG SCI
Meeting the demanding new requirements imposed upon firms by SEC Regulation SCI
is a key issue for many firms, especially in the areas of independent systems testing
and certification. Tellefsen and Company, L.L.C. (Tellefsen) and Exactpro Systems,
LLC (Exactpro) have today announced a marketing partnership in which both firms will
collaborate to provide key industry constituents with market structure consulting, financial
technology infrastructure testing and software quality assurance testing services.
Tellefsen is a management consulting firm founded in 1984 to provide counsel and
professional services to meet the growing needs of the financial services industry. The
firm’s principals and consultants have a wealth of experience in regulatory compliance
and U.S. market infrastructure (exchanges, ATS, dark pools etc). One of Tellefsen’s core
competencies has been is assisting firms with their regulatory compliance requirements
through technology analysis, planning, testing, and evidencing.
Exactpro is a rapidly growing quality assurance services firm specializing in market
infrastructure. Exactpro provides both functional and non-functional testing for global
exchanges, dark pools and clearing houses using a range of sophisticated in-house built
testing and evidencing tools.
John Rapa, President and CEO of Tellefsen, indicates: “The implementation of Reg SCI
is another example of market regulations where market participants must provide evidence
of their comprehensive infrastructure testing, policies and procedures and market oversight
compliance. We are delighted to team up with Exactpro whom we know from other customer
engagements. We are very impressed by their capabilities, diligence and effectiveness in
planning, executing and evidencing tests that prove regulatory compliance”.
Iosif Itkin, Co-Founder of Exactpro, says: “Our firm has a great set of tools and services that
we believe can help clients meet Regulation SCI in a cost effective manner. We are very
conversant with this domain and are delighted to be working with Tellefsen on this; our two
firms’ capabilities are entirely complementary”.
Regulations Impacting Public Refrigerated WarehousesAngela Carver
The government and government regulatory agencies impose guidelines upon supply chain service providers such as public refrigerated warehouses because they have significant impact on product quality and safety as they are typically the last to handle and/or process the inventory before reaching consumers. Because of this direct connection to consumers, product safety is a critical element.
In many cases, cold storage supply chain service providers must quickly adapt their businesses to meet regulatory guidelines regardless of cost to avoid stiff penalties or shut downs. Some of the most recent regulations impacting temperature controlled facilities include the Food Safety Modernization Act (FSMA), the Sanitary Transport Rule, FDA Title 21 CFR Part 11 and the Drug Quality Security Act (DQSA). Each of these affect operations in a unique way and pose a different set of challenges for each PRW.
The FSMA was signed into law by the Obama administration as part of a movement to increase food safety. In this regulation, the FDA is granted additional power through these provisions: expanded administrative detention, records inspection, authority to deny entry, suspension registration and mandatory recall. This was done in hopes of reducing or eliminating the 48 million foodborne illnesses reported each year.
The sanitary transport rule, as part of the FSMA, is an additional safeguard added to prevent transportation practices that may negatively impact food safety. This new rule applies to shippers, receivers and carriers transporting both human and animal food products within or into the US. Shippers hired by PRWs now must follow strict vehicle maintenance guidelines, operational procedures, data exchange, training protocols and record maintenance.
Another regulation impacting public refrigerated warehouses is FDA Title 21 CFR Part 11. This regulation was initially drafted in 1997 and has been subsequently updated to accommodate new and updated technology. This law regulated what type of electronic signature is acceptable and in what cases electronic signatures are considered valid. This helps to streamline audits, system validations and audit trails required by the FDA.
Lastly, for those PRWs handling pharmaceutical inventory, DQSA designates what inventory and transaction data must be saved and available for FDA if requested. This regulation impacts manufacturers, re-packagers, wholesale distributors, 3PLs and dispensers. Under DQSA, businesses must record transaction information, history and statements.
To learn more about regulations impacting public refrigerated warehouses contact Datex cold storage experts today at www.datexcorp.com , marketing@datexcorp.com or 800.933.2839 ext 243.
This presentation provides an overview of the major provisions proposed by the EPA in the new hazardous waste generator improvements rule. It outlines the four primary issues that exist with today's regulations and how some of the more significant proposals seeks to address those issues. Find out about the rule process and schedule and what this means for hazardous waste generators.
Regulatory 101 for Medical Device Start UpsEMMAIntl
In this webinar hosted from EMMA International's Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and device listings.
FLIR Consent Agreement Analysis - Part 1Matt Henson
This presentation discusses the FLIR Consent Agreement, which stemmed from violations of the International Traffic in Arms Regulations (ITAR). The presentation focuses on what went wrong (the Proposed Charging Letter) and touches on the mandatory requirements (Consent Agreement). This is Part 1 in a multi-part series.
TGA Presentation: GMP Clearance Information Session,5-7 September 2017TGA Australia
Provides an overview of the improvements made to the GMP clearance process including the revised guidance, the introduction of an application assistance tool, the redesigned application e-forms and the compliance verification process.
Calgary Oil & Gas Regulatory and Standards Day January 18th 2023Nimonik
On 18th January 2023, Nimonik Inc. hosted the inaugural “Calgary Oil & Gas Regulatory and Standards Compliance Day”. During the event, we covered newly published topics, upcoming regulatory changes for the oil & gas industry, and best practices for compliance management. The event attendees also had the opportunity to connect with industry peers and share compliance challenges.
How to Get Your Recreational (Adult-Use) License and Overcome Roadblocks with...Cannabis Legal Group
How to Get Your Recreational (Adult-Use) License and Overcome Roadblocks with your Municipality by Barton Morris, Principal Attorney Cannabis Legal Group
Raising Private Equity Capital for Expansion, Insurance and Business Mergers/...Cannabis Legal Group
Raising Private Equity Capital for Expansion, Insurance and Business Mergers/Acquisitions by Erik Allison, Managing Partner at Skytree Capital Partners
Thinking of getting a dog? Be aware that breeds like Pit Bulls, Rottweilers, and German Shepherds can be loyal and dangerous. Proper training and socialization are crucial to preventing aggressive behaviors. Ensure safety by understanding their needs and always supervising interactions. Stay safe, and enjoy your furry friends!
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Delivering Micro-Credentials in Technical and Vocational Education and TrainingAG2 Design
Explore how micro-credentials are transforming Technical and Vocational Education and Training (TVET) with this comprehensive slide deck. Discover what micro-credentials are, their importance in TVET, the advantages they offer, and the insights from industry experts. Additionally, learn about the top software applications available for creating and managing micro-credentials. This presentation also includes valuable resources and a discussion on the future of these specialised certifications.
For more detailed information on delivering micro-credentials in TVET, visit this https://tvettrainer.com/delivering-micro-credentials-in-tvet/
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
MATATAG CURRICULUM: ASSESSING THE READINESS OF ELEM. PUBLIC SCHOOL TEACHERS I...NelTorrente
In this research, it concludes that while the readiness of teachers in Caloocan City to implement the MATATAG Curriculum is generally positive, targeted efforts in professional development, resource distribution, support networks, and comprehensive preparation can address the existing gaps and ensure successful curriculum implementation.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Introduction to AI for Nonprofits with Tapp Network
Processing - Operational Guidelines Important for Facility Inspection and Beyond
1. +
How to Maintain Your Grower License:
Navigating the Laws, Rules, and
Regulations between Licensure and
Renewal
NICKOLAS GALENDEZ| CANNABIS LEGAL GROUP
2. +
What happens after I get my Grower License?
1) After obtaining your license, you may naturally focus your energy on your facility,
managing the company, establishing business relationships, and building your brand.
2) There will be uncertainty as well as expected/unexpecteddelays as Michigan’s
medical (and likely adult-use) cannabis industry develops and evolves.
3) It is important to plan ahead, anticipate setbacks, be forward-thinking, and flexible.
4) Licenses are renewable annually.
5) It is important to comply with all regulatory requirements and anticipate/adapt to any
changes so that you are eligible for renewal and able to maintain your license
3. +
The Story of Detroit from MMCC Ordinance to
MMFLA Opt-In: Uncertainty and Delays
4. +
The Story of Detroit from MMCC Ordinance to
MMFLA Opt-In: Uncertainty and Delays
Late 2015 – Michigan Legislature begins winter break; fails to adopt Medical Marihuana Facilities Licensing Act
(MMFLA)
December 17, 2015 – Detroit adopts Medical MarihuanaCaregiver Center (MMCC) Ordinance
March 2016 – Detroit starts accepting MMCC applications
◦ Delays in application process (unanswered questions, “green zones”, public hearings, appeals, lawsuits)
September 2016 – Michigan Legislature adopts MMFLA
November 7, 2017 – Citizens of Detroit pass MMFLA opt-in ballot initiatives
February 16, 2018 – Detroit Judge invalidates parts of MMFLA opt-in ballot initiatives
July 31, 2018 – Detroit adopts MMFLA opt-in ordinance
5. +
The Story of Detroit from MMCC Ordinance to
MMFLA Opt-In: Uncertainty and Delays
TOTAL = 958 DAYS
7. +
Summary of MMFLA Application Process: Uncertainty & Delays
September 2016 – MichiganLegislature adopts MMFLA
December 4, 2017 – LARA issues Emergency Rules
December 15, 2017 – LARA starts accepting MMFLA applications
January2018 – MichiganLegislature amends MMFLA withPublic Act 10 of 2018
February 15, 2018 – “Application Deadline” for Temporary Operators
◦ LARA receives almost 200 MMFLA applications
May 30, 2018 – LARA renews Emergency Rules
June 15, 2018 – Temporary OperationDeadline I
September 11, 2018 – LARA issues new Emergency Rules for Temporary Operators
September 13, 2018 – MichiganCourt of Claimsissues temporary injunction re: September 15 deadline
September 15, 2018 – Temporary OperationDeadline II
October 1, 2018 – LARA issues new Emergency Rules for Temporary Operators II
*October 31, 2018 – Temporary Operation Deadline IV
December 15, 2018 – Temporary OperationDeadline III
8. +
Summary of MMFLA Application Process:
Uncertainty and Delays
◦ Reasons for Uncertainty and Delays
◦ New law, rules, licensing framework, and application process
◦ Comprehensive disclosure requirements
◦ Length of time needed to gather, submit, review, follow up, and respond
◦ Regulatory Assessment Fee
◦ FY 2018 - $48K (except Class A Grower/safety compliance facility)
◦ FY 2019 - $66K (except Class A Grower/safety compliance facility)
◦ Municipal Application Process/Approvals & Closing on Property
9. +
Summary of MMFLA Application Process:
Uncertainty and Delays in Lansing
10. +
Summary of MMFLA Application Process:
Uncertainty and Delays in Warren
11. +
Summary of MMFLA Application Process:
Uncertainty and Delays in Pontiac
12. +
Summary of MMFLA Application Process:
Uncertainty and Delays in Grand Rapids
13. +
Top Three Takeaways
1. Anticipate delays and embrace uncertainty
2. Fully comply with all laws/rules/regulations (and any
changes)
3. Plan for the future and don’t cut corners
14. +
How to Maintain Your License
• Duty to Report
• Changes/Modifications to Facility Plan & Facility
• Regulatory Compliance – Tracking & Recordkeeping
• Inspections/Investigations
• License Renewal
• Grower Facility Operations
• Where to get plants?
• What to do after?
• Pesticide Compliance
15. +
Duty to Report
• Rule 15 – Notification and Reporting
• Rule 16 – Notifications of diversion, theft, loss, or criminal
activity
• Rule 81 – Employees; requirements
16. +
Rule 15 – Notification and reporting
• Continuing duty to provide LARA with up-to-date information
• Must report any changes to facility operations
• Must report material changes to LARA before making any
• Must notify LARA of certain incidents within 1 business day
17. +
Rule 15 – Notification and reporting
• Examples of “material” changes
• Change in owners, officers, members, or managers
• Change of location (will require new license/new inspection)
• Any violations of local ordinance/zoning regulations related to licensed
activities
• Addition or removal of named people
• Change in entity name
• Any attempted transfer, sale, or other conveyance of an interest in a license
• Any change or modification to the facility that was not inspected or part of the
facility plan or final inspection
• Operational/method changes
• Additions or reductions in equipment
18. +
Rule 15 – Notification and reporting
• Must notify LARA within 1 business day if:
• Adverse Reactions to product sold or transferred
• Criminal charges/convictions or civil judgments in any state
• Regulatory disciplinary actions taken in any state (including pending)
• Failure to report = sanctions/fines
19. +
Rule 16 – Notifications of diversion, theft,
loss, or criminal activity
• Must notify within 24 hours:
• LARA
• State police
• Local law enforcement
• Failure to report = sanctions/fines
20. +
Rule 81 – Employees; requirements
• Must have policy that requires employees to report any new or
pending charges or convictions
• Must immediately report to LARA if employee is charged or
convicted of felony
21. +
How to Maintain Your License
• Duty to Report
• Changes/Modifications to Facility Plan & Facility
• Regulatory Compliance – Tracking & Recordkeeping
• Inspections/Investigations
• License Renewal
• Grower Facility Operations
• Where to get plants?
• What to do after?
• Pesticide Compliance
22. +
Changes/Modifications to
Facility Plan & Facility
• Rule 9 – Marihuana facility plan
• Rule 21 – Changes to licensed marihuana facility
• Rule 34 – Building and fire safety
23. +
Rule 9 – Marihuana facility plan
• Must report any changes or modifications to the marihuana
facility plan to LARA
• May require preapproval
• LARA has the authority to reinspect the facility to verify the
facility plan at any time
24. +
Rule 21 – Changes to
licensed marihuana facility
• Any change or modification to the facility after licensure must
be approved by LARA before the change or modification is
made
25. +
Rule 34 – Building and fire safety
• Facility subject to inspection to confirm no health/safety issues
• Must allow LARA to enter and inspect facility at any reasonable
time
• Additional fire safety inspections required if modifications to
grow areas, rooms and storage; other material changes
26. +
How to Maintain Your License
• Duty to Report
• Changes/Modifications to Facility Plan & Facility
• Regulatory Compliance – Tracking & Recordkeeping
• Inspections/Investigations
• License Renewal
• Grower Facility Operations
• Where to get plants?
• What to do after?
• Pesticide Compliance
28. +
Rule 31 – State operating licensees;
licensees; operations; general
• Must maintain records and make available to LARA upon request
• What are “records”? EVERYTHING
• Rule 19(8) – Books, ledgers, documents, writings, photocopies, correspondence,
electronic records, videotapes, surveillance footage, electronic storage media,
electronically stored records, money receptacles, equipment in which records are
stored, including data or information in METRC or any other document that is used
for recording information
29. +
Rule 31 – State operating licensees;
licensees; operations; general
• What needs to be tracked and recorded? EVERYTHING
• All transactions, including current inventory
• All plants and product sold/transferred
• Surveillance and alarm system
• Product destruction and waste management methods
• Inventory storage
• Seed-to-sale tracking
30. +
How to Maintain Your License
• Duty to Report
• Changes/Modifications to Facility Plan & Facility
• Regulatory Compliance – Tracking & Recordkeeping
• Inspections and Investigations
• License Renewal
• Grower Facility Operations
• Where to get plants?
• What to do after?
• Pesticide Compliance
31. +
Rule 17 – Inspection; investigation
• LARA has authority to oversee and conduct inspections to ensure
compliance with the MMFLA and Administrative Rules:
• Investigate individuals employed by facilities
• Inspect and examine facilities
• Inspect, examine, and audit records of licensees
32. +
Rule 17 – Inspection; investigation
• Facility, offices, and other places of business may be entered at
any time if evidence of compliance or noncompliance is likely to
be found
• Possibility of administrative hold; no sales/transfers during
investigation
• Must allow inspection, examination, and audit of relevant records
33. +
Rule 19 – Sanctions; fines
•Sanctions
• License denial; limitations on license
• Removal of licensee or employee
• Revocation, suspension, nonrenewal, or administrative hold
• Orders to cease operations
•Fines (per day)
• Up to $5,000 (individual)
• Up to $10,000 or equal to daily gross receipts (licensee)
34. +
How to Maintain Your License
• Duty to Report
• Changes/Modifications to Facility Plan & Facility
• Regulatory Compliance – Tracking & Recordkeeping
• Inspections and Investigations
• License Renewal
• Grower Facility Operations
• Where to get plants?
• What to do after?
• Pesticide Compliance
35. +
Rule 14 – Renewal of a license
• To renew your license, you must prove that you are:
1. Eligible
2. Qualified
3. Suitable
• Need to timely submit complete renewal application(s)
• “Not less than 90 days before expiration of the license”
36. +
Rule 14 – Renewal of a license
• What information and documents will be required?
• Updated information
• Entity and all Supplemental Applicants
• Facility
• Must be “current, complete, true, and accurate”
• Renewal can be denied if:
• (1) you do not file in time or (2) do not provide all required information
37. +
How to Maintain Your License
• Duty to Report
• Changes/Modifications to Facility Plan & Facility
• Regulatory Compliance – Tracking & Recordkeeping
• Inspections and Investigations
• License Renewal
• Grower Facility Operations
• Where to get plants?
• What to do after?
• Pesticide Compliance
38. +
Where to get plants?
• Language in MMFLA restricts ability to obtain plants from certain sources
• Transition from Emergency Rules to Administrative Rules
• Options available to temporary operators and early licensed facilities will be unavailable
• Changes to Caregiver Transfer/Capitalization and 30-Day Transition Period
39. +
Where to get plants?
• MMFLA - MCL 333.27501(8)
• Within 30 days after license is issued
• Can transfer marihuana plants, seeds, and seedlings IF:
• lawfully possessed by an individual formerly registered primary caregiver
• who is an active employee of the grower
• Ends December 31, 2018
• Alternative Options
• MCL 333.27501(2)
• Grower Facility
• Allowed to sell/transfer plants to grower; must use secure transporter
• Caregiver
• Allowed to sell/transfer seeds, seedlings, or tissue cultures to grower; no secure transporter needed
• Not allowed to sell/transfer plants
40. +
Where to get plants?
• Emergency Rule 20 – 30-Day Transition Period
• Period of thirty (30) calendar days; beginning on day license issued for first time
• Allows for product to be entered into METRC
• No similar language in Administrative Rules
• All product must be purchased and immediately entered into METRC
41. +
Where to get plants?
• Emergency Rule 11 – Capitalization requirements
• Grower
• Class A - $150,000
• Class B - $300,000
• Class C - $500,000
• 25% must be liquid assets to cover initial expenses of operating and maintaining the facility
• Cash, CDs, 401(k), stocks and bonds, and marihuana inventory
• Marihuana Inventory
• Must be possessed by registered patient or primary caregiver
• No more than 15 ounces or 72 plants can be used as inventory and capitalization
• No similar language in Administrative Rules
42. +
What to do after?
• Inventory Tracking, Testing, and Recalls
• Definitions
• Plant – any living organism that produces its own food through photosynthesis and
• (i) has observable root formation OR (2) is in growth material
• Cutting – section of lead stem or root stock used for vegetative sexual propagation
• Seed – fertilized, ungerminated, mature ovule, containing an embryo or rudimentary plant, of the marihuana
plant that is flowering
• Seedling – plant that has germinated and has not flowered and is not harvestable
• Tissue culture – cell, cutting, tissue, or organ, kept under sterile condition on nutrient culture medium of known
composition that does not have visible root formation
• Doesn’t count as a plant
• Batch – same variety grown/harvested/processed together; exposed to substantially similar conditions
• Immature plant – nonflowering; no taller/wider than 8 inches; produced from cutting, clipping, tissue culture, or
seedling; in growing/cultivating medium or container no larger than 2 inches wide/tall; sealed on sides/bottom
• Harvest batch – marihuana that has been harvested
43. +
What to do after?
• Inventory Tracking, Testing, and Recalls
• Rule 45 – Plant batches; testing procedures
• Must uniquely ID each immature plant batch in METRC
• Batch size = 100 immature plants
• Must tag each plant greater than 8x8 inches with individual plant tag; record in METRC
• Must separate plants through different growth stages
• Must ensure plant tag always identified with plant so that all plants can be easily identified and inspected
• After harvest:
• Sample must be tested by safety compliance facility and pass all tests
• Maximum batch size = 15 pounds
• Must be quarantined from other plants/batches
• Must be easily distinguishable from other harvest batches until batch broken down into packages
• After passed test:
• Must destroy individual plant tags; attach package tag; record in METRC
44. +
What to do after?
• Inventory Tracking, Testing, and Recalls
• Rule 46 – Retesting
• Safety compliance facility may retest sample to validate results of failed safety test
• Facility that provided sample is responsible for all costs
• Failed sample must pass two (2) separate retests
• Sample cannot be retested if:
• Product in final package
• Final test for pesticides failed
• If pesticide/active ingredient found banned by LARA, product ineligible for retest; must be destroyed
• Rule 47 – Recalls
• LARA may recall any products, issue safety warnings, and require facilityto provide informationalmaterial or
notifications
45. +
Pesticide Compliance
• Rule 47 – Testing
• Required safety tests:
• THC/THC-A
• CBD/CBD-A
• Foreign matter
• Microbial and mycotoxin
• Chemical residue testing – pesticides, fungicides, and insecticides
• Heavy metals
• Residual solvents
• Water activity/Moisture
• If sample fails, must destroy entire batch; record in METRC
• LARA will publish list of approved pesticide active ingredients, including banned
substances and limits for use in cultivation
49. +
Top Three Takeaways
1. Anticipate delays and embrace uncertainty
2. Fully comply with all laws/rules/regulations (and any
changes)
3. Plan for the future and don’t cut corners