Discussion forum for Pharma Quality events, Regulatory Actions

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

Discussion forum for Pharma Quality events, Regulatory actions (Warning letters, Recalls, 483s, Import alerts; Deviations, OOS, Complaints) and other Pharma Tech Ops topics
Qvents Knowledge sharing & learning platform
Qvents is a knowledge sharing platform focussed on Pharma Quality Systems, GMP and Regulatory topics. Qvents discusses different quality and regulatory events, what causes such events, what companies can do to prevent such events. You can post your comments and replies, seek clarifications and start new discussions. View what industry is doing, learn from industry professionals, peers and seniors, use the learnings for training, development, adopt for enhancing the systems and processes.
Qvents …Come alive with your expertise and knowledge
Qvents focusses on Pharma Quality Events (Qvents), Regulatory observations and actions. You can participate in discussions, contribute your ideas and perspectives, Qvents is a powerful medium where your expertise and knowledge on the subject can come alive, get peer reviewed & commented and get noticed…
Warning letters
USFDA Warning letters are discussed, with analysis of key deficiencies and observations, what can lead to the observations, what you should have in place to meet agency expectations and prevent such observations and evets at your site, company. Read, give your comments, seek clarifications and use the discussions for trainings and audit readiness at your facility.
USFDA 483s
Published USFDA 483s (Inspectional observations issued at the close of inspections) are reviewed and discussed focussing on what can lead to such observations, what you should have in place to meet agency expectations and prevent such observations at your manufacturing site. You can identify the inspector focus, review the post and comments, reply and seek clarifications and use the discussions for trainings and audit readiness at your facility.
Product Recall
Product recalls are cumbersome to execute and close, invite regulatory attention, leads to loss of reputation and harm the patient population if not executed adequately. The product recall posts discusses recalls due to GMP issues focussing on what can lead to such events, and what companies should have in place to prevent such events at the facilities
Discussion forum
Discussion forums on Pharma Tech Ops, Quality, regulatory topics..Post your queries and comments on various topics, learn from industry peers..For the pharma professionals to learn and grow together for better quality and better compliance
Check out the Guidelines page for comprehensive list of guidelines and updates, Learning Resources page for upcoming and archived Trainings and Webinars, News page for latest news on Pharma Quality and regulatory news.
User Profiles Page
Update your profile, get noticed. All your posts, comments, replies can also be viewed from your profile page and you control what others can view and cannot view. Search for profiles of Qvents users, view the profiles, proficiencies and expertise and connect. A great way for Pharma industry to professionals to get noticed and connected!!!
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