Discussion forum for Pharma Quality events, Regulatory Actions

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

Keep learning, Be upto date and Stay relevant!!!

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
Environmental Monitoring Systems: Why and Where to Monitor in Aseptic Processing Areas Environmental Monitoring as per Annexure 1, risk assessment to determine optimal sample point locations, and choose suitable monitoring equipment, examples of installed sensors at critical location #Annexure1, #Particle...Measurement, Particle Measuring Systems 16 Apr 2025 Webinar Free
Overview of USP Microbiology Chapters Microbiology USP best practices, compendial and regulatory guidance on rapid microbiological testing, types of microbiology tests, microbiological detection, enumeration, identification #Microbiology, USP 21 Mar 2025 Webcast Paid
AI in GxP: Opportunities, Challenges and Industry Guidance Insights on current AI trends, EMA & FDA guidance, EU AI Act & legal framework for AI, Use of AI in regulatory decision-making, Validation AI-enabled systems, case studies KENX 19 Mar 2025 Podcast Q&A Session 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