Medicinal Cannabis Seminar | Understanding GACP and GMP
Learning and Development Director Maria Mylonas, arguably the world’s best GMP trainer based on hundreds of GMP and GxP training reviews, was invited to be a Guest Speaker at combined Schimadzu/Scitek Medicinal Cannabis Seminars being held in August.
Learn more about entering the medicinal cannabis industry in Australia or New Zealand.
Here’s the information for the 1-Day seminar – but be sure you register by sending us an email to attend one of the free 1-Day seminars organised by Scitek and Shimadzu.
These 1-Day Australia Medicinal Cannabis Industry Seminars will help new business operators understand unique regulatory requirements for medicinal cannabis cultivation and production operations including GACP and GMP.
Medicinal Cannabis Seminars | Event Snapshot
- 1 Day Seminar (category: Australian/New Zealand Medicinal Cannabis Industry Conferences)
- Free to Attend – register by sending us an email with your details and the preferred seminar date (list the specific venue/date/City)
- Being held in major Australian cities (see schedule further below)
- August 2019 – Various dates
- Starts at 8.30 am; finishes at approximately 4:00 pm
- Featuring Medicinal Cannabis Industry experts — also available for questions during breaks
These informative medicinal cannabis business seminars are ideal for individuals seeking cultivation and production licenses and others wanting future employment in the medicinal cannabis industry in the Australian and/or Asia-Oceana region.
No pre-requisites or prior industry knowledge required.
Presentation on GAMP and GMP for Medicinal Cannabis cultivation and export businesses
Industry expert, Maria Mylonas, will be sharing her pharmaceutical industry expertise and GxP expertise.
- Maria’s presentation will help start-up cannabis business operators in Australia, New Zealand, and other Asia-Oceana countries, understand:
- some of the key regulatory requirements for pharmaceutical businesses
- TGA’s GMP / PIC/S requirements and employee GACP and GMP / GxP training requirements
- quality management regulations / QMS investigations likely to impact cannabis business licence holders and operators
- TGA auditing trends (GMP compliance issues leading to audit failures/product losses when TGA inspects complementary medicine manufacturers)
GMP stands for good manufacturing practices, a crucial component for producing regulated goods, such as scheduled medicines, poisons and medical devices.
GACP stands for good agricultural and collection practices, which are key requirements in the production of herbal medicines including medicinal cannabis.
GACP and GMP in the pharmaceutical cannabis sector (in brief):
- GACP & GMP help manufacturers to produce quality-tested, safety-tested herbal medicines
- Cannabis medicines and supplies must meet regulatory standards (PIC/S Annex 7 for Manufacturing of Herbal Medicines and other GACP / GMP standards) for
- approval for domestic use
- export into larger markets, such as the European market (UK, Germany) and/or USA markets
- maintaining your licence and permits (failures to meet GMP / GACP could lead to withdrawal or cancellation of your licenses and permits; or in the event of fraudulent records, counterfeit medications or substandard products, can also lead to jail time)
Availability of medicinal cannabis in Australia – TGA approval notes:
- medicinal cannabis products are not yet TGA approved in Australia
- however, they are recognised as having potential health-related QOL benefits for some patients and may be accessible by the SAS
- patients and doctors interested in medicinal cannabis treatments must use the Special Access Scheme (SAS), administered by State Agencies
Use and possession of cannabis without a legitimate prescription, by an Authorised Provider and approved under the SAS, remains illegal in Australia.
Maria’s presentations at these 1-Day Seminars will provide start-up cannabis businesses with a helpful overview of GMP (PIC/S regulatory requirements for medicinal cannabis business operators).
This information is important for license applicants to consider when:
- designing business plans and budget allocations
- contemplating site selection, facility architecture, cleanrooms and production workflow designs
- choosing data systems and security systems
- other Quality Management Systems (QMS) criteria, including employee training programs
Who should attend the Medicinal Cannabis Seminars?
These free 1-day “plant to product” seminars are suitable for current and future Australian cannabis business operators or employees including:
- Business Owners
- ODC Cannabis Licence Holders (including future licence applicants or interested Investors)
- Engineering professionals and bio-science graduate students
- Quality management personnel working with herbal medicine manufacturing
- Future job seekers in the cannabis industry in Australia
- Horticulture employees considering entering the sector
- GMP Industry employees and validation engineers considering a career change into medicinal cannabis
AGENDA | Topics and Presenters at the Schimadzu and Scitek hosted Medicinal Cannabis Seminar
Along with Maria Mylonas’s presentations about regulatory requirements, other topics discussed by Organisers/Speakers at the Medicinal Cannabis: From Plant to Product 1-day seminar include:
- Raw Material Testing for Medicinal Cannabis – presented by Rod Finney (Schimadzu)
- Production Basics, Part I – From Plant to Extract – presented by Tobias Schappeler (Scitek)
- Medicinal Cannabis Product Testing – presented by Nigel Grieves (Schimadzu)
- Supporting Growth and extraction methods with CO2 (BOC limited)
- Calibration Standards for Medicinal Cannabis testing (Novachem Pty Ltd)
- Production Basics, Part II – From extract to API – presented by Tobias Schappeler (Scitek)
Seminar Dates | August 2019
All cannabis seminars in August 2019 will start at 8:30 am and end around 4:00 pm. ** No charge to attend **
- PERTH | Location: Bentley, WA | Monday | 19th August
- BRISBANE | Location: near Brisbane Airport | Tuesday | 20th August
- MELBOURNE | Location: near Monash University/Conference area | Wednesday | 21st August
- SYDNEY | Location: Olympic Park | Thursday | 22nd August
How to Register
These 1-Day seminars are available at no charge, but registration via email is a must.
Unable to attend on those dates, but want to learn more about GMP requirements for complementary medicine manufacturing?
- Register for the March 2020 International Cannabis Conference
- Browse our GMP online training course bundles.
- You can also attend small-group GMP training courses.
For more info on the medicinal cannabis cultivation industry in Australia and around the globe:
- Visit the expert cannabis consultants pages for information about start-ups and business expansions for the global medicinal cannabis and pharmaceutical GMP industry.
- Review our top 10 medicinal cannabis industry blogs.
If you need help starting your business, designing your facilities or quality management and data systems, or want ODC application assistance, contact PharmOut’s top medicinal cannabis consultants.
The importance of Good Manufacturing Practices (GMP Basics) for Medicinal Cannabis Business Operators including Export Businesses | In Brief
Good manufacturing practices (PICS / GMP) requirements are important considerations for new medicinal cannabis cultivation and export businesses to fully understand, BEFORE they begin to design their cannabis greenhouses/medicinal cannabis processing facilities (SOPs) or engineer their cleanrooms, testing laboratories, validation procedures, workflows, quality management systems (QMS), security systems, storage and distribution systems for cannabis medicine production and exportation.
- Pharmaceutical-grade cannabis medicines are controlled medications (review the TGA’s pharmaceutical classification/schedule and SUSMP (poisons standard).
- Production, batch traceability, testing, stocktake/storage facilities and distribution processes for these products will be subject to frequent GMP audits
- Intensive investigations should be expected by government agencies, who will evaluate production and distribution in terms of PIC/S GMP and GDP standards
- Pharmaceutical cannabis products and supplies must meet GACP, GMP and GDP requirements; and other GxP standards including security from production to distribution
- They will be subject to rigorous quality management reviews and TGA Audits (or FDA audits for medicinal marijuana suppliers to the USA markets).
Page updated on August 2, 2019.