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Recorded Webinar
The FDA CGMP and Data Integrity in Pharmaceuticals
timelapse 60 Min with 15 Min QnA of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
This Webinar will help your firm to remain in good compliance with the US FDA. Discussion will include methods for maintaining a continuous quality improvement program thereby keeping your site ready for regulatory inspections all of the time.
Potential Negative Consequences of not Complying with CGMP Regulations
If you receive a Warning Letter or you firm is placed on the Import Alert List: you may have to stop manufacturing, recall your products, train all of your employees, validate your manufacturing processes, validate your testing methods and re-qualify your equipment. You will also be required to hire consultants.
This will cost you millions of dollars and could take several years to re-start your production. You will not obtain any new NDA or ANDA approvals and you will not be able to submit any changes to your already approved applications. Your stock price will go down. You may lose your customers and you may have to close your facilities.
This presentation will also include a summary of recent Warning Letters and Import Alerts issues to Indian Pharma.
Key Areas Covered During the Webinar:
- You will learn these Good Compliance Practices from a former FDA Investigator and CDER Compliance Officer
- This Webinar will help your firm to remain in Good Compliance with the US FDA
- Discussion will include methods for maintaining a continuous quality improvement program
- Provide methods for avoiding FDA-483 observations
- Good Practices on how to verbally respond to FDA-483 observations during the exit meeting
- You will learn the potential negative consequences of not complying with CGMP regulations
- This presentation will also include a summary of recent Warning Letters and Import Alerts issues
- Learning from competitors mistakes will prevent you from making these same mistakes
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