Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

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Links to selected learning resources from different regulatory agencies, technology forums, industry leaders (USFDA, EMA, EDQM, WHO, ISPE, PICS, APIC, CEFIC, Industry leaders)– Trainings, Webinars, Seminars, Webcasts, Workshops are listed. Many of the programmes are free

Topic/Subjects Agency/Provider Date Type Free/Paid
Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products Intricacies in development opthalmic products, BE studies , challenges in generics, invitro drug release testing, qualitative (Q1) & quantitative (Q2) sameness of complex ingredients, characterisation FDA & CRCG 20 Nov 2025 Workshop Free
Managing Method Variability: A Foundation for Risk-Based Change Understanding sources of method variability—reagent, instrument, operator, sample preparation, data processing, examples, justifying changes due to shift in materials, instruments, processes #Analytical Validation, Peter Baker & Waters 02 Dec 2025 Webinar Free
2025 EDQM Virtual Training Programme: Module 1: General methods, General chapters and General monographs Fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.), walk-through of the structure of the Ph. Eur, correct use of general monographs, dosage form monographs and general chapters EDQM 01 Dec 2025 Webinar Free
2025 EDQM Virtual Training Programme: Module 2: Individual monographs Individual monographs of actives, excipients, medicinal products, link between individual, general monographs and general chapters, policy for medicinal product monographs, titles, dissolution tests EDQM 02 Dec 2025 Webinar Free
Optimizing Environmental Monitoring: The Science of Particle Loss Explains significance of particle loss in sample tubing, key variables that influence particle transmission efficiency, risk-based approach to the qualification of environmental monitoring systems #Environmental Monitoring, Particle Measuring Systems (PMS) 19 Nov 2025 Webinar Free
IPEC Good Distribution Practices Guide for Pharmaceutical Excipients Overview of the WHO Medical Product Alerts related to contaminated pharmaceutical products, Detailed review of the IPEC GDP Guide for Pharmaceutical Excipients, prevention of contamination risks #Contamination control, IPEC Europe 27 Nov 2025 Webinar Paid
Temperature Control and Digital Transformation in Pharmaceutical Production Facilities Energy impact of chilled and hot water pumping systems in pharma production plants. Intelligent, automated single & multi-pump controllers, integrated variable frequency drives for energy efficiency Grundfos Pumps 11 Dec 2025 Presentation Free
Nitrosamines in Pharmaceuticals: Navigating Risk, Regulation & Innovation Latest nitrosamine guidance, acceptable intake limits, NDSRIs & CPCA Methodology, Using structure–activity relationships, high-sensitivity techniques like LC-MS/MS for nitrosamines detection & control Waters 04 Dec 2025 Webinar Free
USP 382: A Systems Thinking Approach to Achieve Optimal Primary Packaging Performance New USP<382>, functional suitability and testing for elastomeric components, vial stoppers pre-filled syringe components, cartridges, container closure integrity, and overall system performance. Aptar Pharma 08 Dec 2025 Webinar Free
Best Practices in HPLC Sample Preparation with SPE Improving HPLC results through better solid-phase extraction (SPE). fix common issues like Poor recoveries, Variable recoveries, High levels of contamination in samples, Poor method robustness CHROMacademy 11 Dec 2025 Webcast Free
Analytical Strategies for Complex Biotherapeutics -icIEF-UV/MS Integrated capillary isoelectric (icIEF) with UV and MS, Charge variant analysis via icIEF-UV/MS for protein structure, stability profile through forced degradation evaluation for complex molecules LCGC 09 Dec 2025 Webcast Free
Trainings and Webinars Archives

The trainings and webinars archives page lists carefully selected useful and informative free learning resources available online. These webinars, workshops, seminars and webcasts are programmes that occurred in the past provide valuable information, knowledge and learning on various GMP & Regulatory topics. Please click here to go to the page - Trainings and Webinars Archives