REGISTER Workshop Details Dates January 23, 2025 Time 2:00 pm – 4:00 pm Cost CAD $600.00 + HST Location Online Deadline January 16, 2025 Workshop Overview Quality Assurance professionals play a pivotal role in ensuring compliance with standard operating procedures and regulatory requirements. However, merely addressing deviations is insufficient without a robust strategy to prevent their recurrence. Identifying and addressing the underlying root causes is paramount to establishing a resilient quality management system. This workshop goes beyond surface-level analysis and embraces a holistic approach to process improvement. By leveraging Lean principles, participants will explore innovative methods for root cause identification.. READ MORE »
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 »
REGISTER Workshop Details Dates September 18, 2024 Time 2:00 pm – 3:00 pm Cost CAD $99.00 + HST Location Online Deadline September 11, 2024 Workshop Overview Data integrity is a cornerstone of quality assurance in any regulated industry. Reliable data is crucial for making informed decisions, ensuring compliance, and protecting patient safety. Unmanaged and inaccurate data can lead to severe consequences, including compromised product quality, regulatory non-compliance, and increased risks to patients. The FDA and other regulatory bodies have stringent expectations for data integrity, requiring firms to implement robust strategies to manage data integrity risks effectively. This webinar provides a.. READ MORE »
REGISTER Workshop Details Dates May 16, 2025 Time 1:00 pm – 2:00 pm Cost FREE Location Online Deadline May 9, 2025 Workshop Overview The newly released ICH E6(R3) Good Clinical Practice (GCP) guidelines mark a transformative shift in clinical trial design, conduct, and oversight. This workshop will provide an in-depth analysis of these changes and their real-world applications, equipping clinical research professionals with the knowledge to implement them effectively. The latest revisions emphasize modernized trial methodologies, enhanced technology adoption, greater flexibility in trial designs, and a stronger focus on patient-centric approaches. Through case studies and expert discussions, attendees will gain.. READ MORE »
REGISTER Workshop Details Dates October 28, 2024 Time 1:00 pm – 5:00 pm Cost CAD $345 + HST Location Online Deadline October 21, 2024 Workshop Overview The implementation of Good Manufacturing Practices (GMPs) is essential for maintaining product quality and ensuring regulatory compliance in industries such as Pharmaceuticals, Cosmetics, and Food. High Performance Liquid Chromatography (HPLC) is a powerful analytical technique that plays a critical role in these industries, offering unmatched sensitivity, selectivity, accuracy, and reproducibility in the quantitation of analytes. This half-day webinar is designed to provide a comprehensive understanding of how HPLC can be effectively employed in GMP-compliant.. READ MORE »
REGISTER Workshop Details Dates October 17, 2024 Time 9:30 am – 3:30 pm Cost CAD $595.00 + HST Location On-Site Deadline October 10, 2024 Workshop Overview This comprehensive workshop delves into the intricate world of Cleaning Validation in the pharmaceutical industry. The entire Cleaning Validation Program will be comprehensively examined, from Cleaning Process development to ongoing monitoring to ensure effectiveness.Led by a seasoned professional, the workshop will also provide hands-on training in a GMP laboratory setting. Students will participate in a realistic Cleaning Validation sample analysis by HPLC. Results will be calculated and compared to typical specification limits. This will.. READ MORE »
REGISTER Workshop Details Dates April 17, 2025 Time 2:00 pm – 4:00 pm Cost CAD $150 + HST Location Online Deadline April 10, 2025 Workshop Overview This introductory workshop provides a foundational understanding of Regulatory Affairs in the healthcare industry, focusing on the drug development process and new drug submissions. Participants will gain insights into the steps involved in getting a new drug approved, including the different notice types, priority review policies, and the importance of pre-submission meetings. The workshop also covers the submission formatting and screening process, with an emphasis on the Common Technical Document (CTD) and the advantages.. READ MORE »
