Qvents

Qvents

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

Search your Topics

Popular: Warning Letters, Recalls

Latest News

  • USFDA Issues Warning Letter to Read More

    Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in January 2025. This was along expected lines, after serious data integrity issues and CGMP violations observed by FDA investigators Justin A. Boyd and Teresa I....

    February 17, 2025
  • FDA Issues Warning letter to Read More

    FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing to meet USP specifications, inadequate stability data, deficient cleaning validation and inappropriate controls over incoming material testing. The FDA inspected Wuhu Nuowei Chemistry Co., Ltd...

    February 12, 2025
  • Timeline for Revised Schedule M Read More

    Health Ministry in India has extended the timeline for implementation of the revised Schedule M by one year for MSMEs. The new timeline for implementation of the revised Schedule M by MSMEs (Micro Small and Medium Enterprises) with a turnover...

    January 30, 2025
No more posts to show
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

Qvents Forums

All
Handing OOT Batches
icon 14 Views
icon 0 Likes
icon 0 Replies
Betalactams, Cytotoxic Contaminations
icon 18 Views
icon 0 Likes
icon 0 Replies
Does all APIs with amine functional group carry risk of Nitrosamine formation
icon 82 Views
icon 0 Likes
icon 0 Replies
Endotoxin Testing in Purified Water
icon 76 Views
icon 0 Likes
icon 0 Replies
OEB &OEL
icon 147 Views
icon 0 Likes
icon 0 Replies
Follow Us..............Share

Popular: Warning Letters, Recalls

Qvents News

  • USFDA Issues Warning Letter to Read More

    Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in January 2025. This was along expected lines, after serious data integrity issues and CGMP violations observed by FDA investigators Justin A. Boyd and Teresa I....

    February 17, 2025
  • FDA Issues Warning letter to Read More

    FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing to meet USP specifications, inadequate stability data, deficient cleaning validation and inappropriate controls over incoming material testing. The FDA inspected Wuhu Nuowei Chemistry Co., Ltd...

    February 12, 2025

Guidelines

Pharma Jobs

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

Qvents Forums

All
Conclusive and Inconclusive invalidated OOS (Out of Specification)
icon 346 Views
icon 0 Likes
icon 1 Replies
System suitability in UV Methods
icon 394 Views
icon 0 Likes
icon 1 Replies
Excel sheet validation
icon 373 Views
icon 0 Likes
icon 1 Replies
pH of Purified Water
icon 301 Views
icon 0 Likes
icon 1 Replies
USFDA Guidance on Cleaning Validation
icon 281 Views
icon 0 Likes
icon 1 Replies

Qvents News

  • USFDA Issues Warning Letter to Read More

    Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in January 2025. This was along expected lines, after serious data integrity issues and CGMP violations observed by FDA investigators Justin A. Boyd and Teresa I....

    February 17, 2025
  • FDA Issues Warning letter to Read More

    FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing to meet USP specifications, inadequate stability data, deficient cleaning validation and inappropriate controls over incoming material testing. The FDA inspected Wuhu Nuowei Chemistry Co., Ltd...

    February 12, 2025

Guidelines

Pharma Jobs

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

No more posts to show
Follow us on

Search your Topics

Popular: Warning Letters, Recalls

Latest News

  • USFDA Issues Warning Letter to Read More

    Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in January 2025. This was along expected lines, after serious data integrity issues and CGMP violations observed by FDA investigators Justin A. Boyd and Teresa I....

    February 17, 2025
  • FDA Issues Warning letter to Read More

    FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing to meet USP specifications, inadequate stability data, deficient cleaning validation and inappropriate controls over incoming material testing. The FDA inspected Wuhu Nuowei Chemistry Co., Ltd...

    February 12, 2025
  • Timeline for Revised Schedule M Read More

    Health Ministry in India has extended the timeline for implementation of the revised Schedule M by one year for MSMEs. The new timeline for implementation of the revised Schedule M by MSMEs (Micro Small and Medium Enterprises) with a turnover...

    January 30, 2025