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!!!
Previous
Next

Latest Posts

Follow us on
Facebook Linkedin Twitter

Search your Topics

Popular: Warning Letters, Recalls

Latest News

  • FDA Issues Repeat Warning Letter Read More

    The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP violations observed during an inspection at the firm's Bang Phli District facility in September 2024. International Laboratories Corp (ILC) is a Thailand based manufacturer and...

    March 25, 2025
  • Strides Recall Several Lots of Read More

    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...

    March 17, 2025
  • Glenmark Recalls Over 1.5 Million Read More

    Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication, Atomoxetine, across the US and Europe due to the presence of the nitrosamine impurity N-Nitroso atomoxetine. This marks the first recall of Atomoxetine for the...

    March 3, 2025
Show More
No more posts to show
View all
Digital platform for Pharma TechOps professionals: Pharma GMP News, Quality & Regulatory Events, Warning letters & USFDA 483s, Product Recalls, Guidelines, Discussion Forums, Trainings, Pharma Jobs, Networking
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!!!
Previous
Next
Qvents: Pharma Information, learning and knowledge platform
Qvents publish news and expert review posts on Pharma Quality & Regulatory events, Warning letters, 483s, alerts, recalls, enforcement actions; Deep review of What causes the events, What should be in place to prevent such events, Actions & CAPAs.

Be informed about current concerns and focus areas of regulators and auditors; Share your views, comments, hear from industry peers….

Qvents Forums
Discussion forums on Pharma GMP, Quality, Regulatory, TechOps topics – Create your Topics, Post your Queries, Join discussions on current Topics in the Forum, post your comments!!!
Pharma Guidelines
Access the most UpToDate Pharma Quality, Regulatory, Technical Guidelines / Guidances from different agencies; All related guidelines on each topic from different agencies at one place (USFDA, EDQM, EMA, WHO, TGA, ICH, Professional bodies like ISPE, PDA and others)
Qvents Learning Resources
Qvents list select Learning Resources - Trainings, Webinars, Seminars, Conferences from different agencies, professional bodies, organisations, SMEs and Experts. Register for upcoming events; View past events from archives.
Pharma Jobs
Browse Pharma job openings. Search jobs with key words. Register your profile in Qvents and Search for Jobs matching your profile.

Pharma Job Listing / Employers

List your Job Openings with Qvents; Search for profiles matching the jobs requirements; View profiles, Connect with candidates.

Subscribe to Qvents.
Get email updates on new Posts, News, new Forum Discussions & Topics.

Register & Update your Profile.
Update your profile at Qvents. Search for Jobs matching your profiles.
Updating your profile helps in networking with Industry peers. Helps Employers to find your profile and connect with you
Previous
Next

Qvents Posts

View All

Qvents Forums

View All

All
Popular
Featured
Recent
Unsolved
Solved
Handing OOT Batches
user circle QueriesQvents
time outline 1 month, 2 weeks ago
topics OOS, OOT
icon 32 Views
icon 0 Likes
icon 0 Replies
Betalactams, Cytotoxic Contaminations
user circle QueriesQvents
time outline 1 month, 3 weeks ago
Contamination Control
icon 45 Views
icon 0 Likes
icon 0 Replies
Does all APIs with amine functional group carry risk of Nitrosamine formation
user circle Qvents Team
time outline 5 months, 1 week ago
Nitrosamines
icon 109 Views
icon 0 Likes
icon 0 Replies
Endotoxin Testing in Purified Water
user circle QueriesQvents
time outline 5 months, 3 weeks ago
Water systems
icon 102 Views
icon 0 Likes
icon 0 Replies
OEB &OEL
user circle Qvents Team
time outline 7 months, 2 weeks ago
Clean Rooms and Clean Room controls
icon 166 Views
icon 0 Likes
icon 0 Replies
Follow Us..............Share
Facebook Linkedin Twitter

Popular: Warning Letters, Recalls

Qvents News

View All

  • FDA Issues Repeat Warning Letter Read More

    The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP violations observed during an inspection at the firm's Bang Phli District facility in September 2024. International Laboratories Corp (ILC) is a Thailand based manufacturer and...

    March 25, 2025
  • Strides Recall Several Lots of Read More

    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...

    March 17, 2025

Guidelines

View All

Pharma Jobs

View All

Qvents: Pharma Information, learning and knowledge platform
Qvents publish news and expert review posts on Pharma Quality & Regulatory events, Warning letters, 483s, alerts, recalls, enforcement actions; Deep review of What causes the events, What should be in place to prevent such events, Actions & CAPAs.

Be informed about current concerns and focus areas of regulators and auditors; Share your views, comments, hear from industry peers….

Qvents Forums
Discussion forums on Pharma GMP, Quality, Regulatory, TechOps topics – Create your Topics, Post your Queries, Join discussions on current Topics in the Forum, post your comments!!!
Pharma Guidelines
Access the most UpToDate Pharma Quality, Regulatory, Technical Guidelines / Guidances from different agencies; All related guidelines on each topic from different agencies at one place (USFDA, EDQM, EMA, WHO, TGA, ICH, Professional bodies like ISPE, PDA and others)
Qvents Learning Resources
Qvents list select Learning Resources - Trainings, Webinars, Seminars, Conferences from different agencies, professional bodies, organisations, SMEs and Experts. Register for upcoming events; View past events from archives.
Pharma Jobs
Browse Pharma job openings. Search jobs with key words. Register your profile in Qvents and Search for Jobs matching your profile.

Pharma Job Listing / Employers

List your Job Openings with Qvents; Search for profiles matching the jobs requirements; View profiles, Connect with candidates.

Subscribe to Qvents.
Get email updates on new Posts, News, new Forum Discussions & Topics.

Register & Update your Profile.
Update your profile at Qvents. Search for Jobs matching your profiles.
Updating your profile helps in networking with Industry peers. Helps Employers to find your profile and connect with you
Previous
Next

Qvents Posts

View All

Qvents Forums

View All

All
Popular
Featured
Recent
Unsolved
Solved
Conclusive and Inconclusive invalidated OOS (Out of Specification)
user circle QueriesQvents
time outline 1 year, 6 months ago
topics OOS, OOT
icon 378 Views
icon 0 Likes
icon 1 Replies
System suitability in UV Methods
user circle QueriesQvents
time outline 1 year, 6 months ago
Methods, Validations
icon 451 Views
icon 0 Likes
icon 1 Replies
Excel sheet validation
user circle QueriesQvents
time outline 1 year, 6 months ago
Computer System Validation (CSV)
icon 412 Views
icon 0 Likes
icon 1 Replies
pH of Purified Water
user circle QueriesQvents
time outline 1 year, 6 months ago
Water systems
icon 338 Views
icon 0 Likes
icon 1 Replies
USFDA Guidance on Cleaning Validation
user circle QueriesQvents
time outline 1 year, 6 months ago
Cleaning Validation
icon 314 Views
icon 0 Likes
icon 1 Replies

Popular: Warning Letters, Recalls

Facebook Linkedin Twitter Icon_mail_alt Whatsapp

Qvents News

View All

  • FDA Issues Repeat Warning Letter Read More

    The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP violations observed during an inspection at the firm's Bang Phli District facility in September 2024. International Laboratories Corp (ILC) is a Thailand based manufacturer and...

    March 25, 2025
  • Strides Recall Several Lots of Read More

    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...

    March 17, 2025

Guidelines

View All

Pharma Jobs

View All

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!!!
Previous
Next

Latest Posts

Show More
No more posts to show
Follow us on
Facebook Linkedin Twitter

Search your Topics

Popular: Warning Letters, Recalls

Latest News

  • FDA Issues Repeat Warning Letter Read More

    The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP violations observed during an inspection at the firm's Bang Phli District facility in September 2024. International Laboratories Corp (ILC) is a Thailand based manufacturer and...

    March 25, 2025
  • Strides Recall Several Lots of Read More

    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...

    March 17, 2025
  • Glenmark Recalls Over 1.5 Million Read More

    Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication, Atomoxetine, across the US and Europe due to the presence of the nitrosamine impurity N-Nitroso atomoxetine. This marks the first recall of Atomoxetine for the...

    March 3, 2025
View all