FINAL CALL: 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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Your Weekly Event Guide: Expand Your Learnings and Discover Exciting Opportunities

Register Now!

Discover the top events for you in our Weekly Event Guide GMP Compliant Temperature Mapping Jan 29 | 1:00 PM - 3:30 PM (EST) (Online) Chemistry, Manufacturing and Controls (CMC) Webinar Jan 30 | 9:00 AM - 5:00 PM (EST) (Online) SoP Masterclass: Writing Effective Standard Operating Procedures Feb 5 | 1:30 PM - 4:30 PM (EST) (Online) Are you ready to expand your learnings? Broaden your knowledge and delve into new horizons with AAPS! LEARN MORE!

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Strengthening CAPA Through Lean Thinking and Root Cause Analysis

Register by January 30 and save 20 percent with code SAVE20

Greetings! Quality systems fail when corrective action stops at fixing symptoms instead of preventing recurrence. Many CAPA processes focus on closing deviations, but without clear problem definition and true root cause identification, the same issues continue to reappear. In regulated environments, this not only weakens compliance but also creates operational inefficiency, inspection risk, and unnecessary rework. This workshop introduces a Lean-based approach to CAPA that moves beyond surface-level explanations such as “human error” and focuses on process design, workflow clarity, and systemic improvement. Participants will learn how Lean principles can be applied to identify non-value-added activities, define problems accurately, map real operational processes, and develop corrective actions that address root causes rather than symptoms. The emphasis is on building CAPA systems that strengthen both regulatory compliance and day-to-day operational performance. The session is designed for quality assurance professionals, internal auditors, regulatory compliance teams, and professionals working in pharmaceutical, biotechnology, and medical device environments who are responsible for CAPA systems, inspections, and quality oversight. It is equally valuable for those seeking to strengthen their understanding of Lean problem-solving, process improvement, and sustainable quality system design. The workshop is led by Terry Pilkey, a Chartered Chemist with over 30 years of experience in the pharmaceutical industry, including more than 13 years at Health Canada within the Health Product Branch Inspectorate and current leadership as Director of QA/QC at Experchem Laboratories Inc. Her experience spans GMP inspections, compliance oversight, auditing, and laboratory quality systems, bringing both regulatory and operational perspectives into applied learning. Register by January 30 to receive an early bird discount of 20 percent. Use code SAVE20 at registration. Date & Time Feb 26, 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 416-628-7575 or email us at events@aapspharma.com

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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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