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 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 November 8, 2024 Time 2:00 pm – 4:00 pm Cost CAD $150 + HST Location Online Deadline November 1, 2024 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 »
REGISTER Workshop Details Dates May 16, 2024 Time 9:00 pm – 5:00 pm Cost CAD $625 + HST Location Online Deadline May 9, 2024 Workshop Overview In 2003, the International Council on Harmonization (ICH) finalized guidance on marketing applications for drugs and biologics. Today, the Common Technical Document (CTD) format, recommended by ICH, is indispensable for marketing applications across various global jurisdictions, including mandatory use in regions such as Canada, Japan, Europe, and the U.S.A. Furthermore, the electronic Common Technical Document (eCTD) format has emerged as a necessity in key markets for electronic submissions, with mandatory adoption in several regions… READ MORE »
REGISTER Workshop Details Dates Sep 14, 21, 28 Oct 5, 12, 19, 2024 Time 9:30 am – 3:30 pm Cost CAD $1995.00 + HST (15% off of $2250) Location Toronto Campus – 885 Sheppard Avenue West, Toronto, ON Deadline Sep 7, 2024 Workshop Overview This comprehensive workshop delves into the intricate world of High Performance Liquid Chromatography (HPLC), a fundamental analytical technique employed across diverse industries including pharmaceuticals, biotechnology, food, cannabis and environmental sciences. HPLC serves as a cornerstone for compound analysis due to its efficacy in separating organic compounds for property analysis. Led by seasoned professionals, the workshop provide.. READ MORE »
REGISTER Workshop Details Dates September 19, 2024 Time 1:00 pm – 3:00 pm Cost CAD $395 + HST Location Online Deadline September 12, 2024 Workshop Overview In the Pharmaceutical industry, auditing contractors, vendors, and suppliers isn’t just a regulatory requirement—it’s a vital quality practice. Ensuring GMP compliance and robust Quality systems within these partnerships is crucial, yet often overlooked. Effective auditing is essential, guaranteeing that external entities meet the required quality standards, resulting in regulatory compliance and enhanced product quality. The role of an auditor in the pharmaceutical industry demands a diverse skill set—from the fundamentals of auditing to intricate.. READ MORE »
REGISTER Workshop Details Dates October 8, 2024 Time 2:00 pm – 4:00 pm Cost CAD $600.00 + HST Location Online Deadline October 1, 2024 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 July 25, 2024 Time 1:00 pm – 4:00 pm Cost CAD $245.00 + HST (50% off of $485 – limited time only) Location Online Deadline July 18, 2024 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.. 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 »
