Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
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We value your feedback on the Posts, Discussions, Information presented by Qvents. Also write to us on Pharma Quality and Regulatory topics and subjects you would like Qvents to cover. Your feedback helps us in making and maintaining the Qvents portal as a useful resource for Pharma TechOps professionals. Please also write to us for general feedback, quality of contents, any irrelevant or offensive posts, threads, comments
Please feel free to contact us for any enquiries.
Email: contact@qvents.in
Phone: (+91) 9945519525
The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence – for GxP computerised systems which interface with Artificial Intelligence models to predict or classify data with direct impact on patient safety, quality and data integrity. For...
The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted for Medical devices by third Party testing facilities. As per the notification...
Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US due to presence of benzene contaminant as per California State Board of Pharmacy Recall Alert. The benzene contaminant is resulting from one of the excipients...
