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X-ORIGINAL-URL:https://www.aaps.ca
X-WR-CALDESC:Events for AAPS
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DTSTART:20200101T000000
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BEGIN:VEVENT
DTSTART;TZID=UTC:20200304T130000
DTEND;TZID=UTC:20200304T150000
DTSTAMP:20260429T093952
CREATED:20190801T232117Z
LAST-MODIFIED:20230119T203651Z
UID:11255-1583326800-1583334000@www.aaps.ca
SUMMARY:Live Webinar How to Write Effective Standard Operating Procedures (SOPs)
DESCRIPTION:SOP Must Haves	\n	\n	\n \n\n\nAbstract:\nRegulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. SOPs provide the main forum for the documentation of a Company’s systems\, processes and operations. SOPs are therefore the most popular documents audited by Regulatory Agencies during GMP inspections to ensure they reflect current practices that follow regulatory requirements and they are followed as written. \nEffective SOPs lead a company not only to consistency\, quality and compliance but also to executing efficient business operations. Often SOPs are written without consultation with the end user or by someone who has good writing skills but little experience of the topic. They can include too much information\, making them difficult to follow or too little detail causing them to be ambiguous. Such SOPs can lead to audit observations that the SOPs had not been followed or did not reflect current or acceptable practices. \nThis course is designed to provide helpful information and essential training towards achieving effective SOPs. It includes topics relevant to the writing\, formatting\, execution and management of SOPs and relates to the role which SOPs play in achieving the required level of compliance and quality.  \nCourse Outline\n\nWhat is an SOP?\nWhy do we need SOPs?\nWhen do we need SOPs?\nRoles and Responsibilities\nSections of an SOP\nWriting Tips\nHow SOPs are Written\nChange Control\nMaintenance\nSOP Workshop\n\nNote: Course outline is subject to change without notice. Please check back regularly for updates. \nWho Should Attend\nThis 2-hour webinar is targeted at anyone involved in the organization\, writing or management of SOPs required for GMP\, GPP\, GVP or GCP purposes.
URL:https://www.aaps.ca/event/live-webinar-how-to-write-effective-standard-operating-procedures-sops
LOCATION:AAPS Training Center\, 200 Consumers Road\, Suite 200\, Toronto\, Ontario\, M2J 4R4\, Canada
CATEGORIES:Live Webinars
ATTACH;FMTTYPE=image/jpeg:https://www.aaps.ca/wp-content/uploads/1920x560-Desktop-Live-Webinar.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20200305T130000
DTEND;TZID=UTC:20200305T150000
DTSTAMP:20260429T093952
CREATED:20190730T003705Z
LAST-MODIFIED:20240206T164839Z
UID:10846-1583413200-1583420400@www.aaps.ca
SUMMARY:Live Webinar GMP Fundamentals
DESCRIPTION:Annual GMP Masterclass 2024\n\n\n\n\nCourse Overview\nThis webinar examines the history\, rationale\, purpose\, and GMP requirements applicable to the manufacturing\, packaging and labeling\, testing\, and control of pharmaceutical products and consequence of inaction.\nGain practical knowledge in understanding of the essential elements and quality systems required for GMP and for maintaining compliance in the pharmaceutical industry. \nCourse Outline\n\n	Assuring Quality in the workplace\n	The benefits of GMP compliance\n	Management Responsibilities for GMP\n	SISPQ/principles of drug production\n	Principles of GMP\n	Training/Effective Training Requirements\n	GMP Documents\n	Standard Operating Objectives\n	Quality Control/Quality Assurance\n	Methods and Specifications\n	Sanitation Programs\n	Out of Specification and Deviation Investigations\n	Production Controls\n	Good Documentation Practice\n	Record Keeping\n	Validation and their types\n	Effective Change Control\n	Industry Trends\n	Hosting Inspectors and Auditors\n\nWHO SHOULD ATTEND\nThis course is valuable for Directors\, Managers\, Supervisors\, Associates in the Pharmaceutical\, Biopharmaceutical\, Vitamins\, Herbals\, Medical Devices and allied industries with daily responsibilities in the following areas: \n\n	Regulatory Affairs\n	Clinical Research\n	Quality Assurance\n	Documentation and Technical Writing\n	Product Submission\n	Project Management\n	Training\n	Product Development\n	Consultants\n	Others who interact together to launch a product
URL:https://www.aaps.ca/event/live-webinar-gmp-fundamentals
LOCATION:AAPS Training Center\, 200 Consumers Road\, Suite 200\, Toronto\, Ontario\, M2J 4R4\, Canada
CATEGORIES:Live Webinars
ATTACH;FMTTYPE=image/png:https://www.aaps.ca/wp-content/uploads/Annual-GMP-Masterclass-2024-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20200310T020000
DTEND;TZID=UTC:20200310T153000
DTSTAMP:20260429T093952
CREATED:20190801T231111Z
LAST-MODIFIED:20230120T133643Z
UID:11252-1583805600-1583854200@www.aaps.ca
SUMMARY:Live Webinar Sanitation Program for Cannabis Production – Cannabis Act
DESCRIPTION:Sanitation Program for Cannabis Production	\n	\n		\n \n\n\nCourse Overview\nGood Production Practices (GPP) of the Cannabis Act mandates that Licensed Producers ensure the cleanliness of the premises and equipment. Having effective sanitation and pre-operational Inspection procedures can minimize the risk of contamination of your product\, ingredients\, processing aids\, packaging materials\, and product contact surfaces. \nIt is therefore extremely important to understand the fundamental principle of sanitation procedures and to implement and use these procedures effectively. Lack of proper and validated cleaning and sanitation program can result in costly contamination\, return of products\, and recalls. \nThis course and workshop concentrate on three important aspects of an effective sanitation program; Premise\, Equipment and Personnel. Participants are given a thorough understanding of the importance of cleaning and sanitizing procedures and their responsibilities\, and why these are important parts of their (and not cleaners`) jobs. \nCourse Outline\n\nCannabis Regulations-Review Sanitation Requirement\, Expectation and Current Guidance\nWhat is Sanitation\nSanitation Program for\n\nPremise\nEquipment\nPersonnel\n\nSanitation Procedure (SOP) for\n\nPremise\nEquipment\nPersonnel\n\nSanitation Verification\n\nWho\, When\, What\, How\n\nSanitation Checklist\nPre-Operational Inspection\nSanitation Records\nRole of QA\nTraining of Personnel\nCleaning Agents\n Pest Control\n\nNote: Course outline is subject to change without notice. Please check back regularly for updates.
URL:https://www.aaps.ca/event/live-webinar-sanitation-program-for-cannabis-production-cannabis-act
LOCATION:AAPS Training Center\, 200 Consumers Road\, Suite 200\, Toronto\, Ontario\, M2J 4R4\, Canada
CATEGORIES:Live Webinars
ATTACH;FMTTYPE=image/jpeg:https://www.aaps.ca/wp-content/uploads/1920x560-Desktop-Live-Webinar.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20200312
DTEND;VALUE=DATE:20200314
DTSTAMP:20260429T093952
CREATED:20190731T001018Z
LAST-MODIFIED:20211129T195203Z
UID:10921-1583971200-1584143999@www.aaps.ca
SUMMARY:Cannabis Retail Operations and Management Workshop
DESCRIPTION:Cannabis Retail Operations and Management Workshop	\n\n\n\nLive interactive and instructor led\n \n \nAbstract\nThe Cannabis Act establishes that provincial\, territorial and municipal governments will determine the framework for the retail distribution of cannabis. As a result of each province creating their own retail model\, a patchwork system has formed across Canada with different rules and regulations depending on what province and municipality you plan to operate in.  \nOpportunities to establish private cannabis retail businesses will be available in Ontario\, Alberta\, Saskatchewan\, Manitoba\, Yukon\, Nunavut\, Newfoundland and Labrador. Applications for a cannabis retail licence will be primarily handled by the liquor and gaming control boards of each province. It is important for potential retailers to properly prepare themselves in order to ensure that they will successfully obtain the required licence(s) and authorization. \nThis workshop will help guide you through the application process including the form and manner for submitting an application for a Cannabis Operator Licence and Store Authorization in Ontario and the information that is required to be submitted. A thorough overview of the Cannabis Retail Act will be provided focusing on the Registrar’s standards that have been established. This includes store and security requirements\, advertising and promotional restrictions\, required staff training\, background checks\, record keeping and documentation practices\, and maintaining compliance with the federal cannabis tracking system. \nCourse Outline\n\nCannabis Retail Regulations\, Licensing and Application Requirements\nCannabis Botany\, Product Categories and Responsible Retailing\nCannabis Retail Operations\nSupply Chain Management\, Buying and Merchandising\nStore Design and Layout\nStaff management\, training and development.\n\nThis course will deliver the tools to enable you to:\n\nApply for a Cannabis Retail Operator or Store Authorization Licence\nUnderstand best practices related to store and security requirements\nDevelop knowledge on the various cannabis products available in the Canadian market\nOwn and operate your own cannabis retail store\nUnderstand the supply chain in relation to cannabis in Ontario\nProper procedures for hiring\, training and developing staff.\n\nWho Should Attend\nCannabis industry professionals including employers and employees\, those who are interested in obtaining a cannabis retail licence\, or retail store manager licence.  \nCertificate of Attendance and Course Material\n\nAll participants will receive a certificate of attendance upon completion of the course.\nThe participants will be receiving specially prepared course manual.
URL:https://www.aaps.ca/event/cannabis-retail-operations-and-management-workshop
LOCATION:AAPS Training Center\, 200 Consumers Road\, Suite 200\, Toronto\, Ontario\, M2J 4R4\, Canada
CATEGORIES:Live Webinars
ATTACH;FMTTYPE=image/jpeg:https://www.aaps.ca/wp-content/uploads/1920x560-Desktop-workshops.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20200318T140000
DTEND;TZID=UTC:20200318T163000
DTSTAMP:20260429T093952
CREATED:20190730T233725Z
LAST-MODIFIED:20211208T174725Z
UID:10905-1584540000-1584549000@www.aaps.ca
SUMMARY:Review of the Safe Food for Canadians Regulations and Preventative Control Plan
DESCRIPTION:Live Webinar Review of the Safe Food for Canadians Regulations and Preventative Control Plan    \n    \n\n        \n  \n\n\n\n\n\n\n\n\n\n \nCourse Overview\nThe Safe Food for Canadians Regulations (SFCR) came into force on January 15\, 2019. This course will provide guidance to the food industry on the regulatory changes introduced by the SFCR. At the end of the course\, participants will be able to understand the regulatory requirements that need to be met\, apply for licence\, identify and implement changes to company’s Preventative Controls to meet the Canadian Food Inspection Agency’s (CFIA’s) requirements. \nBenefit of the SFCR:\nFor trading partners abroad\, it means that they can continue to buy with confidence\, knowing that food produced in Canada meets internationally recognized safety standards. \nFor industry\, the SFCR’s outcome-based regulations mean innovation and the production of safer food. Businesses can better avoid costly recalls\, be more competitive at home and abroad\, and increase their growth potential by accessing an even greater number of international markets. \nCourse Outline\n\nWhat are the regulatory changes introduced by the SFCR?\nWhat is expected of the regulated parties/food industries?\nHow can the food industries meet the new regulations?\nWhich sectors are affected?\nWhat are the licensing requirements?\nHow to apply for licence?\nWhat are Preventative Control Plans (PCPs) and its elements?\nHow to meet traceability requirements under SFCR?\nUnderstand the requirements for Importers.\nUnderstand the requirements for Exporters.\nImplementation timelines for licensing\, PCPs and traceability\nCFIA’s new inspection model\n\nNote: Course outline is subject to change without notice. Please check back regularly for updates. \nWho Should Attend\n\nAuditors\nConsultants to the food and cannabis edible industries\nPersonnel working in the food manufacturing\, processing\, import and export\nCannabis Edible industry\nOwners/Operators of Food Businesses\nFacility Managers & Directors\nFood Safety Personnel\nHACCP Team Members\nQA/QC Managers\, Technicians & Supervisors\nSupply Chain Managers
URL:https://www.aaps.ca/event/review-of-the-safe-food-for-canadians-regulations-and-preventative-control-plan
CATEGORIES:Live Webinars
ATTACH;FMTTYPE=image/jpeg:https://www.aaps.ca/wp-content/uploads/1920x560-Desktop-Live-Webinar.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20200327T140000
DTEND;TZID=UTC:20200327T153000
DTSTAMP:20260429T093952
CREATED:20190731T004018Z
LAST-MODIFIED:20200408T001730Z
UID:10939-1585317600-1585323000@www.aaps.ca
SUMMARY:Live Webinar Optimization of a Pharmaceutical Granulation Process using Quality by Design (QbD)
DESCRIPTION:Live Webinar Optimization of a Pharmaceutical Granulation Process using Quality by Design (QbD)	\n	\n		\n	Register online \n\n\nDates Available\nMay 22\, 2020 \nTime\n2:00 p.m – 3:30 p.m. \nCost\nCAD $345.00 + HST \nLocation\nOnline Webinar \nDistinguished Faculty\nAndy Tallevi Formulation/Process Consultant\nKeller Consulting \n\n\nAndy Tallevi is a Formulation/Process Consultant for Keller Consulting in Mississauga\, Ont.\, Canada. He has 28 years of industrial experience\, primarily in the Pharmaceutical industry. He currently consults clients in the Pharma and chemical industries assisting them with formulation and process issues and is an instructor at AAPS. \nMost recently Andy spent 1 year with Health Canada in the Bureau of Pharmaceutical Sciences reviewing and evaluating generic submissions and making recommendations for approval or refusal of Notice of Compliance for the Bureau. He has gained significant insights to the regulatory requirements and expectations of the drug substance and drug product sections of a submission filing to Health Canada. In addition\, he has an excellent understanding of the regulatory requirements for pharmaceutical development\, the GMP requirements expected for pharmaceutical manufacture and has assisted former employers numerous times in audits by Health Canada and the FDA. \nPrior to this\, Andy worked as a Senior Pharmaceutics Scientist for GlaxoSmithKline in Canada. During his 18 years with the company he led many projects developing new chemical entities in varying dosage forms. His specialty is solid oral dosage forms. He and his team successfully formulated immediate release tablets as well as many controlled release versions of GSK new chemical entities. He has experience with conventional matrix approaches as well as proprietary technologies such as Procise® and DiffCORE®. He has been responsible for overseeing the manufacture of clinical supplies of NCEs both in Canada and at other GSK sites in Europe and the US. \nAndy also has a solid understanding of material properties required of excipients and actives for successful formulation and for robust processes. He is well versed on particle sizing and powder flow. He holds a US patent on a novel approach for the assessment of the flow of pharmaceutical powders. \nPrior to leaving GSK he was heavily involved in a company-wide effort to strengthen its processes by Design for Manufacture through the use of PAT and experimental design for which he was the lead user in Mississauga. \nPrior to GlaxoSmithKline Andy worked as a scientist for Unilever developing products in the health\, beauty and detergent industries. He graduated from the University of Toronto with a B.Sc. major in Chemistry. \nAndy lives in Mississauga with his wife and 2 children. \nCourse Overview\nFor many years pharmaceutical companies have placed considerable effort in developing robust manufacturing processes to assure the highest quality products\, minimize defects\, eliminate rejects and conform to all Regulatory requirements. These processes are developed by scientists using past knowledge and 1 variable-at-a-time experiments and then subjected to process validation. Unfortunately\, more often than not\, even validated processes fail. \nAt the core of this problem is the fact that full process knowledge has not been acquired and all critical factors have not been identified. This implies that the manufacturing process can drift into a region not fully explored and produce an output that falls outside acceptable limits. \nFor the past decade and more the pharmaceutical industry\, supported by Regulators\, has been looking to Quality by Design (QbD) to remedy this problem. In pharmaceutical manufacturing the concept is to carry out experimentation and analysis using multivariate statistical techniques to determine all the factors influencing the process (critical factors)\, determining the complete region around those factors that produce a given output (design space) and then determining the optimal portion of the design space that produces the desired output within limits (optimization). \nIn this webinar participants will learn about:\n\nBasic concepts of Quality by Design (QbD)\nAdvantages of QbD over traditional 1 variable-at-a-time experimentation\nStatistical experimental design\nCritical factors\nFactor interactions\nDesign space\nInterpretation of data derived from QbD\nA real life example of QbD applied to a pharmaceutical granulation process to fully understand the critical factors and the optimal operating range within the design space for those factors\n\nNote: Course outline is subject to change without notice. Please check back regularly for updates. \nWho Should Attend\nThe webinar is suitable for those who are seeking to get a basic understanding of the concept of Quality by Design and its application to pharmaceutical processing including personnel in Production\, Quality Assurance\, Quality Control\, Validation and Development.
URL:https://www.aaps.ca/event/live-webinar-optimization-of-a-pharmaceutical-granulation-process-using-quality-by-design-qbd
LOCATION:AAPS Training Center\, 200 Consumers Road\, Suite 200\, Toronto\, Ontario\, M2J 4R4\, Canada
CATEGORIES:Live Webinars
ATTACH;FMTTYPE=image/jpeg:https://www.aaps.ca/wp-content/uploads/1920x560-Desktop-Live-Webinar.jpg
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