REGISTER Workshop Details Dates March 13, 2025 Time 1:00 pm – 4:00 pm Cost CAD $485.00 + HST Location Online Deadline March 6, 2025 Workshop Overview Temperature control is critical for maintaining the integrity of pharmaceutical products. Health Canada’s Guide 0069, “Temperature Control of Drug Products during Storage and Transportation,” mandates that drug products must be transported, handled, and stored within their labeled storage conditions to mitigate the risk of temperature excursions. Whether dealing with ambient, refrigerated, frozen, dry ice, or liquid nitrogen conditions, preventing cold chain failures is essential to protect product quality. To comply with these regulations, it.. READ MORE »
REGISTER Workshop Details Dates October 16, 2024 Time 1:00 pm – 2:30 pm Cost CAD $395.00 + HST Location Online Deadline October 9 , 2024 Workshop Overview In the dynamic landscape of regulatory affairs within the medical device, IVD, and pharmaceutical/biologics industries, confusion often arises between Regulatory Strategies, Plans, and Tactics. This webinar aims to unravel this confusion by delineating the differences between a Regulatory Strategy and a Regulatory Plan, offering practical insights to streamline operational processes and enhance strategic clarity.Drawing from extensive experience in Regulatory Affairs, our experts will address the impact of operational confusion, highlighting the inefficiencies and.. READ MORE »
REGISTER Workshop Details Dates January 30, 2025 Time 9:00 am – 5:00 pm Cost CAD $645.00 + HST Location Online Deadline January 23, 2025 Workshop Overview The objective of this workshop is to provide participants with a comprehensive understanding of the importance and underlying principles of Chemistry, Manufacturing, and Controls (CMC) requirements from a regulatory perspective. Attendees will gain in-depth knowledge of the CMC section of the Common Technical Document (CTD), the required format for regulatory submissions in Canada and the EU. This workshop will equip participants with the skills needed to effectively compile and present CMC data, ensuring compliance.. READ MORE »
REGISTER Workshop Details Dates February 20, 2025 Time 1:30 pm – 4:30 pm Cost CAD $395 + HST Location Online Deadline February 13, 2025 Workshop Overview Computer System Validation (CSV), or Software Validation, is a critical regulatory requirement mandated by Health Canada, the FDA, and the European Union. This regulation ensures that all computerized systems or automated data processing systems used in the healthcare industry (including Pharma, Medical Devices, Logistics, and Warehousing) are validated for their intended use according to established pre-defined protocols before production use. This workshop provides a foundational understanding of Software Validation and its regulations throughout the.. READ MORE »