Natural Health Products Regulation Workshop Early Bird Available

Register by January 29 and save 20 percent with code SAVE20

Greetings! Understanding how Natural Health Products are regulated in Canada is essential for anyone involved in developing, licensing, marketing, or maintaining compliance for these products. This workshop provides a clear and practical overview of how NHPs are regulated under the Food and Drugs Act and the Natural Health Products Regulations, including the roles of Health Canada, the NNHPD, and enforcement bodies. Participants will learn what qualifies as an NHP, how NHPs differ from drugs and supplemented foods, and why correct product classification is critical to avoiding compliance risk. The session walks through the full regulatory lifecycle of an NHP, from product classification and licensing to post market obligations. Attendees will gain practical insight into application classes, monographs, claims and evidence requirements, traditional and homeopathic products, and the regulatory tools used to submit and manage applications. The workshop also covers operational requirements such as labeling, adverse reaction reporting, recalls, and ongoing compliance responsibilities, helping participants understand what regulators expect both before and after licensing. This workshop is designed for professionals and students who work with, or plan to work with, Natural Health Products in Canada and need a solid understanding of regulatory expectations. It is particularly relevant for those in regulatory affairs, quality assurance, product development, manufacturing, labeling, compliance, and market authorization roles, as well as importers, distributors, consultants, and entrepreneurs bringing NHPs to market. Students in life sciences, nutrition, health sciences, pharmaceutical sciences, or regulatory affairs will also benefit from the foundational, applied perspective offered. The session is led by Andreea Simo, a regulatory affairs and quality professional with experience across global organizations such as PepsiCo and Jamieson Vitamins, as well as consulting firms and start ups. Her background spans regulatory affairs, product development, and quality assurance for natural health products and foods, offering a balanced view of how products are developed, assessed, and brought to market in real world settings. Register by January 29 to receive an early bird discount of 20 percent. Use code SAVE20 at registration. Date & Time Feb 20, 2026 11:00 AM - 2:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. REGISTER TODAY Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

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LAST 24 HOURS: EU-GMP for Cannabis Sites: A Practical Readiness Workshop

Map Health Canada to EU-GMP, close gaps, and prepare for inspections with confidence.

Greetings! If you’re running a Health Canada - licensed cannabis site and considering EU markets, EU-GMP can feel confusing and heavier than it needs to be. This workshop is designed to break it down in a practical, step-by-step way. We’ll look at how your current Health Canada framework maps to EU-GMP, where the real gaps usually show up, and what actually needs to change to move toward EU readiness. The focus is on clarity, not theory, so you leave knowing what inspectors expect and how to prepare with confidence. The session is meant for owners and site leaders planning EU entry, QA and RA professionals, QAPs, operations and production managers, compliance and documentation teams, project managers handling certification timelines, and consultants or auditors supporting GMP readiness. If EU-GMP is on your roadmap, or even just being discussed internally, this session will help you make informed decisions. We’ll cover EU-GMP in plain language and walk through how it differs from Health Canada requirements. From there, we’ll discuss what auditors actually look for in QMS design, facilities, equipment, utilities, and training programs. We’ll also talk through the path from readiness to certification, what inspection day typically looks like, and how to build a compliance culture that holds up beyond a single audit. There will be time for practical next steps and open Q&A. By the end of the workshop, you’ll be able to map your Health Canada compliance posture to EU-GMP clauses and annexes, identify and prioritize the gaps that matter most, and strengthen or refine your QMS so it meets EU auditor expectations. You’ll understand how to plan validation and qualification activities with proper documentation, prepare a focused evidence package for inspections, and estimate realistic timelines, costs, and decision points for EU certification. The session is led by Mussarat Fatima, a Quality Assurance and Regulatory Affairs leader with over 20 years of experience across pharmaceuticals, cannabis, food, and biotech. She has guided dozens of organizations through Health Canada licensing with zero major audit findings, built high-performing QA teams, and led digital QMS implementations that significantly reduced audit response times. Mussarat is known for translating complex regulations into practical systems, SOPs, and training that work in real operating environments. Date & Time Jan 23, 2026 2:00 PM - 4:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. REGISTER TODAY Interested in this workshop? Register today by calling our team at 416-502-2277 or email us at info@aaps.ca

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Hello, ensure compliance with GMP temperature control

Learn when, why, and how temperature mapping supports product quality and regulatory expectations.

Greetings! Temperature control is critical to maintaining the quality, safety, and integrity of pharmaceutical products. Health Canada’s Guide 0069, Temperature Control of Drug Products during Storage and Transportation, requires that drug products be handled, stored, and transported within their labeled temperature conditions to prevent excursions that may compromise product quality. Effective temperature management across ambient, refrigerated, frozen, dry ice, and liquid nitrogen conditions is essential throughout the product lifecycle. This workshop provides a practical overview of GMP Temperature Mapping and its role in supporting regulatory compliance and operational control. Participants will explore best practices for managing temperature across a wide range of storage and transportation environments, including rooms, warehouses, freezers, fridges, incubators, trailers, tanks, and shipping containers. The session also covers when temperature mapping should be conducted, including routine assessments, following equipment or process changes, and when unexplained temperature variability is observed. Beyond compliance, temperature mapping generates valuable data that supports real-time monitoring and informed decision-making. Through this workshop, participants will gain an understanding of how to design and execute temperature mapping studies, analyze data, prepare clear summary reports, and interpret findings to maintain consistent product conditions and support continuous improvement. The session is suitable for professionals involved in quality assurance, logistics, and regulatory compliance, as well as those seeking to strengthen their understanding of temperature control within pharmaceutical, biotechnology, and medical device environments. Date & Time Jan 29, 2026 1:00 PM - 3:30 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. REGISTER TODAY Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

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FINAL CALL: Understanding CMC Requirements for Regulatory Submissions

A practical workshop on CTD Module 3, regulatory expectations, and compliant CMC documentation.

Greetings! This workshop is designed to help participants build a clear, practical understanding of Chemistry, Manufacturing, and Controls (CMC) from a regulatory standpoint. CMC is one of the most critical parts of any regulatory submission, and this session focuses on why it matters, how it is assessed by regulators, and how it should be presented within the Common Technical Document (CTD) for Canada and the EU. Participants will learn how to compile and organize CMC information in a way that supports compliance, clarity, and successful regulatory review. The session is well suited for professionals working in regulatory affairs, quality assurance, and product development within the pharmaceutical and biopharmaceutical space. It is particularly relevant for those involved in preparing, reviewing, or managing CMC content, including regulatory submission specialists, technical writers, project managers, and quality and analytical teams. Consultants and others who support regulatory submissions will also benefit from gaining a stronger understanding of how CMC expectations are applied in practice. Participants will be guided through the role of CMC across the drug development lifecycle, from drug substance characterization and nomenclature to analytical methods and validation. The workshop also covers manufacturing processes, in-process controls, process validation, and the development of meaningful specifications for drug substances and drug products. Stability testing, stability-indicating methods, and how to manage acceptable post-approval changes are discussed in the context of regulatory expectations. By the end of the workshop, participants will be more confident in understanding and preparing the CMC section of regulatory submissions. They will gain practical insight into how regulators evaluate CMC data, how Drug Master Files are used, and how to structure and present information clearly and effectively. The goal is to enable participants to contribute to stronger, more defensible submissions that support product quality and regulatory compliance. Date & Time Jan 30, 2026 9:00 AM - 5:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. REGISTER TODAY Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

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SOPs Under the Microscope: Writing Procedures Inspectors Actually Test

Learn how to write clear, audit-defensible SOPs that reflect real operations and withstand GMP inspections.

Greetings! Standard Operating Procedures are not just a documentation requirement - they are one of the clearest indicators regulators use to assess how well an organization actually operates. During GMP inspections, SOPs are routinely examined to confirm that processes are clearly defined, aligned with regulatory expectations, reflect current practices, and are followed exactly as written. Gaps between documented procedures and real-world execution are among the most common and costly audit findings. This upcoming SOP Masterclass is designed to close that gap. The session focuses on how to write SOPs that are practical, unambiguous, and audit-defensible. Participants will learn how to determine when SOPs are required, how to structure them correctly, how to define roles and responsibilities, and how to write instructions that are clear enough to be executed consistently across teams. Equal emphasis is placed on managing SOP updates through effective change control and maintaining documents so they remain current as operations evolve. The workshop is particularly relevant for professionals involved in creating, reviewing, approving, or managing SOPs under GMP, GPP, GVP, or GCP frameworks. Quality Assurance and Regulatory Affairs professionals, technical writers, and team leads responsible for compliance and inspection readiness will gain directly applicable skills. Early bird registration is currently open - register by January 26 to receive 20% off using code SAVE20 at checkout. By the end of the session, attendees will walk away with a practical understanding of SOP fundamentals, proven writing techniques, and hands-on experience applying best practices - enabling them to develop SOPs that support operational efficiency, withstand regulatory scrutiny, and reduce inspection risk. Date & Time Feb 5, 2026 1:30 PM - 4:30 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. REGISTER TODAY Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

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