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 Twitter Google-plus

Search your Topics

Popular: Warning Letters, Recalls

Latest News

  • USFDA Announces Second Quality Management Read More

    USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. It provides opportunity for a limited number of drug manufacturers to participate in the programme to evaluate Quality Management Maturity. CDER will accept...

    April 24, 2025
  • WHO Publishes Comprehensive Guidelines for Read More

    WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in pharmaceutical products. The TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products is applicable for...

    April 18, 2025
  • CDSCO Not of Standard Quality Read More

    The Central Drugs Standard Control Organisation (CDSCO) has published the NSQ (Not of Standard Quality) list of drugs for February 2025. The list comprises two parts—one detailing drugs identified as NSQ by Central Laboratories and the other by State Laboratories....

    April 9, 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 2 months, 2 weeks ago
topics OOS, OOT
icon 54 Views
icon 0 Likes
icon 0 Replies
Betalactams, Cytotoxic Contaminations
user circle QueriesQvents
time outline 2 months, 2 weeks ago
Contamination Control
icon 65 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 6 months, 1 week ago
Nitrosamines
icon 130 Views
icon 0 Likes
icon 0 Replies
Endotoxin Testing in Purified Water
user circle QueriesQvents
time outline 6 months, 3 weeks ago
Water systems
icon 119 Views
icon 0 Likes
icon 0 Replies
OEB &OEL
user circle Qvents Team
time outline 8 months, 1 week ago
Clean Rooms and Clean Room controls
icon 187 Views
icon 0 Likes
icon 0 Replies
Follow Us..............Share
Facebook Twitter Google-plus

Popular: Warning Letters, Recalls

Qvents News

View All

  • USFDA Announces Second Quality Management Read More

    USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. It provides opportunity for a limited number of drug manufacturers to participate in the programme to evaluate Quality Management Maturity. CDER will accept...

    April 24, 2025
  • WHO Publishes Comprehensive Guidelines for Read More

    WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in pharmaceutical products. The TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products is applicable for...

    April 18, 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, 7 months ago
topics OOS, OOT
icon 409 Views
icon 0 Likes
icon 1 Replies
System suitability in UV Methods
user circle QueriesQvents
time outline 1 year, 7 months ago
Methods, Validations
icon 500 Views
icon 0 Likes
icon 1 Replies
Excel sheet validation
user circle QueriesQvents
time outline 1 year, 7 months ago
Computer System Validation (CSV)
icon 435 Views
icon 0 Likes
icon 1 Replies
pH of Purified Water
user circle QueriesQvents
time outline 1 year, 7 months ago
Water systems
icon 355 Views
icon 0 Likes
icon 1 Replies
USFDA Guidance on Cleaning Validation
user circle QueriesQvents
time outline 1 year, 7 months ago
Cleaning Validation
icon 343 Views
icon 0 Likes
icon 1 Replies

Popular: Warning Letters, Recalls

Facebook Twitter Google-plus WordPress WordPress

Qvents News

View All

  • USFDA Announces Second Quality Management Read More

    USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. It provides opportunity for a limited number of drug manufacturers to participate in the programme to evaluate Quality Management Maturity. CDER will accept...

    April 24, 2025
  • WHO Publishes Comprehensive Guidelines for Read More

    WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in pharmaceutical products. The TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products is applicable for...

    April 18, 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 Twitter Google-plus

Search your Topics

Popular: Warning Letters, Recalls

Latest News

  • USFDA Announces Second Quality Management Read More

    USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. It provides opportunity for a limited number of drug manufacturers to participate in the programme to evaluate Quality Management Maturity. CDER will accept...

    April 24, 2025
  • WHO Publishes Comprehensive Guidelines for Read More

    WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in pharmaceutical products. The TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products is applicable for...

    April 18, 2025
  • CDSCO Not of Standard Quality Read More

    The Central Drugs Standard Control Organisation (CDSCO) has published the NSQ (Not of Standard Quality) list of drugs for February 2025. The list comprises two parts—one detailing drugs identified as NSQ by Central Laboratories and the other by State Laboratories....

    April 9, 2025
View all