Posts Tagged: Workshop Info

Developing an Effective CAPA Strategy

REGISTER Workshop Details Dates June 20, 2024 Time 2:00 pm – 4:00 pm Cost CAD $600.00 + HST Location Online Deadline June 13, 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 »

GMP Compliant Temperature Mapping

REGISTER Workshop Details Dates July 25, 2024 Time 1:00 pm – 4:00 pm Cost CAD $485.00 + HST Location Online Deadline June 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 product quality. To comply with these regulations, it.. READ MORE »

Regulatory Strategy – Medical Devices and Other Health Technologies

REGISTER Workshop Details Dates May 30, 2024 Time 1:00 pm – 2:30 pm Cost CAD $395.00 + HST Location Online Deadline May 23, 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 risks.. READ MORE »

Chemistry, Manufacturing and Controls Workshop

REGISTER Workshop Details Dates June 27, 2024 Time 9:00 pm – 5:00 pm Cost CAD $645.00 + HST Location Online Deadline June 20, 2024 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 »

Cleaning Validation in the Pharmaceutical Industry Workshop

REGISTER Workshop Details Dates June 14, 2024 Time 9:30 am – 3:30 pm Cost CAD $595.00 + HST Location Online Deadline June 7, 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 »

Drug Product Submission (NDS) Preparation in CTD and eCTD format Workshop

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 »

Advanced HPLC Certification

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 »

GMP Audits, Inspections, Preparation and Management

REGISTER Workshop Details Dates June 6, 2024 Time 1:00 pm – 3:00 pm Cost CAD $395 + HST Location Online Deadline May 30, 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 »

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