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
Nitrosamine Mitigation: Leveraging Next Gen Technologies Discusses 3-Phase Activ-Polymer platform technology, N-Sorb – that scavenges nitrosating agents, volatile nitrosamines, and inhibits NDSRI growth in the packaging headspace #NDSRI, #Nitrosamines, Apstar 25 Jun 2025 Webinar Free
PCM: Measuring Content Uniformity with PAT & RTR (in oral solid dose applications) Technical solutions for content uniformity (CU), on-line, in-line, and at-line measurements in PCM, integration of PAT-based devices, sensor technologies, control strategy and release (RTR) examples #Uniformity of Dosage Units, USP 26 Jun 2025 Webcast Free
How to Perform a Compliant Human Error Investigation Human error is rarely the actual root cause but a symptom of systemic issues. Discusses tools and methodologies, step-by-step framework for investigating human errors, Root Cause Determination Tool #Investigation Deficiencies, ISPE 26 Jun 2025 Webinar Free
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection, Environment Explore foundations of AI/ML, AI Validation Workflows and Process, trends in AI/ML, real life case studies featuring Predictive Maintenance, Defect Detection, Environmental Monitoring, CAPAs #Maintenance Issues, ISPE 19 Jun 2025 Webinar Free
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems Overview of updated GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice, emerging technologies, opportunities & challenges posed by AI ISPE 17 Jun 2025 Webinar Free
Microbial Contamination: Common Pitfalls and How to Avoid Them Most common contamination causes and how to prevent them, gaps in gowning, aseptic technique, and environmental monitoring. Understand microbial trending, tips on setting alerts and action limits #Contamination control, #Microbial Controls, KENX 25 Jun 2025 Webcast Free
Introduction to GC-MS Fragmentation and Interpretation Explore fragmentation by electron impact ionization, covalent bonding theory, odd and even electron species, Ionization site formation and stabilization, charge retention and migration fragmentation Chromacademy 19 Jun 2025 Webcast Free
Mastering Nitrosamines analysis: From Method Development To Analysis Challenges with sample preparation, separation, detection limits, optimisation of LC & MS conditions, identify unknowns with full-scan MS/MS data acquisition with MRM > EPI using QTRAP technology #Nitrosamines, Pharmaceutical Technology 26 Jun 2025 Webinar Free
Introduction to Peptide Mapping Exploring peptide analysis, synthetic peptides, protein digestion, amino acid properties and peptide behavior, enzymatic digestion strategies, chromatographic & mass spectrometric techniques Chromacademy & Agilent 01 Jul 2025 Webcast Free
Biosimilars: Meeting the FDA with Your Biosimilar Product Effective strategies for FDA meetings, how to demonstrate biosimilarity through analytical characterization, clinical study design, interchangeability data. FDA expectations common submission pitfalls USP & Pharmatech 25 Jun 2025 Live 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