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 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 February 27, 2025 Time 2:30 pm – 4:30 pm Cost CAD $150 + HST Location Online Deadline February 20, 2025 Workshop Overview Standard Operating Procedures (SOPs) are vital for ensuring consistency, quality, and compliance in regulated industries. Regulatory agencies require documented procedures for all systems and operations impacting the safety and quality of pharmaceutical products. SOPs are among the most frequently audited documents during GMP inspections to verify they reflect current practices, follow regulatory standards, and are adhered to as written. This masterclass provides essential training for developing SOPs that are clear, practical, and effective. Participants.. 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 20, 2024 Time 1:00 pm – 3:00 pm Cost CAD $395 + HST Location Online Deadline September 13, 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 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 »
