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RE: FDA Investigator Overreach

Posted by:Jonathan Amaya-Hodges, 19 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

I concur with Peter: the observations of the inspector may be modified or removed by management, which is one reason why it takes so long for the EIR to become available. Additionally, it may be useful read more
RE: FDA Investigator Overreach

Posted by:Peter Smith, yesterday

Discussion

Found in: Regulatory Open Forum Discussions

First, the FDA Investigator's observation is not the final agency decision. If you are unable to change the Investigator's mind and the issue finally appears on an FDA-483, you can respond (within 15 business read more
FDA Investigator Overreach

Posted by:, 2 days ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous How do you handle it when, even after your pushback, an FDA investigator still insists on reporting your firm as having violated FDA law read more
CDER NextGen Portal Account

Posted by:Ahmed Soliman, 2 days ago

Discussion

Found in: Regulatory Open Forum Discussions

Hi everyone, As a new member of RAPS, I wanted to express how much I am enjoying my experience so far. I have encountered a question for which I have been unable to find an answer. Recently, my boss read more
RE: Critical materials for unapproved supplier

Posted by:Arvilla Trag, 2 days ago

Discussion

Found in: Regulatory Open Forum Discussions

The term "root cause analysis" is used to describe an investigation that uses the 5 Questions approach to discover the actual source of a deviation, nonconformity, whatever you choose to call it, as there read more

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CDER NextGen Portal Account

By: Ahmed Soliman , yesterday

Posted in: Regulatory Open Forum

Hi everyone, As a new member of RAPS, I wanted to express how much I am enjoying my experience so far. I have encountered a question for which I have been unable to find an answer. Recently, my boss left the company after establishing a communication ...
How to Continue my Career Growth in Regulatory

By: Anonymous Member , yesterday

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hi All, Due to an unexpected layoff, I found myself looking for a job for quite a while. The job search has been very long and I had a hard time finding an opening. I recently was offered ...
These 105 professionals passed their RAC exams in spring ...

By: Ryan Connors , 2 days ago

Posted in: Regulatory Open Forum

RAPS today announced the names of 105 professionals who passed their RAC in the spring examination window, which spanned March and April 2023. These professionals have obtained their RAC-Drugs or RAC-Devices designation, the leading credentials for ...
BIMO - master investigator list and lock point

By: Anonymous Member , yesterday

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous For the purposes of preparing a master investigator list to complete BIMO requirements in a BLA/NDA, what is the clinical operations milestone that is most appropriate to use? Data cutoff ...
Member Q&A: Despina Vasiliou, regulatory affairs manager ...

By: Ryan Connors , 2 days ago

Posted in: Regulatory Open Forum

I'm excited to unveil our latest member Q&A! Despina Vasiliou joined me for a chat about her career path, her thoughts on the regulatory profession and more. "I started off in regulatory affairs, actually, by accident," she says. "I had graduated ...