FDA Form 483 and Warning Letter - Understanding FDA Procedure

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This training will help viewers to understand many topics related to FDA Form 483 and Warning Letter - Understanding FDA Procedure.
Below points are discussed during this session -
Possible Regulatory or Enforcement Pathways
What is a Form FDA 483?
What should I do during the closing discussion and Form FDA 483 review?
Post FDA 483 - How to Respond?
What Should Your Response Include?
Understanding of warning letter.
Issuing Warning Letters - Factors to Consider by FDA
Purpose of issuing a warning letter
Ongoing or Promised Corrective Actions
Response Letter
Verification of Corrective Actions
Multiple Centre Review
Warning Letters Response - Time Frame
Link to download Regulatory Procedures Manual September 2018 Chapter 4-Advisory Actions - www.fda.gov/me...
Link to download FDA Compounding QualityCenter of Excellence What to ExpectAfter an Inspection - www.fda.gov/me...
Link to download the training material - we.tl/t-AOhq5l... (This link will valid only for April 16,2023)

[@vijay18panneer]

Kindly make video HVAC system with important guidline reference.....

[@hitendrakumarshah3718]

Sure. I will make training on it.

[@mongsama79]

Thank you for your video. It`s very honour to watch your video.
I wanna ask you something.
In the case of Elevar therapeutics and Jiangsu Heungrui, they received form483 from FDA.
I thought that FDA didnt complete EIR. So they got a CR LETTER.
When they can receive EIR Release?

[@hitendrakumarshah3718]

Thank you for your kind comment. Once the CAPA is accepted by the compliance team of FDA, EIR will be issued by FDA

[@anildesai334]

Please share FDA guidelines

[@hitendrakumarshah3718]

You can get the link from the description of the recorded webinar. You can access from the same link.

[@machindrasarak7665]

Sir nice session .Informative one.please provide guideline referance

[@hitendrakumarshah3718]

You can get the guideline link from the description section of the same recorded webinar.

[@yogeshsalunkhe8332]

Please share FDA SOP as discussed in this session

[@hitendrakumarshah3718]

You can check the description section. The link is shared to download the FDA document.

[@anildesai334]

When should FDA issue EIR? What will be time frame after inspection?

[@hitendrakumarshah3718]

For EIR, there is no time frame for FDA

[@Aditya-pq1dr]

What is the role of USFDA regarding 483....they only issue 483 but not guiding regarding US federal standard.

[@hitendrakumarshah3718]

They guide and also provide training to the people. You can download the FDA training slides from the description section of the same recorded webinar.

[@ganesh659]

After receipt of compliance report by FDA, how many days FDA will take for review and clearance? Any time limit is there?

[@hitendrakumarshah3718]

Normally it takes about 15 business days to review CAPA by FDA.

[@shaileshmewada9788]

Sir will u share ur slides also so that it will be easy to recollect all

[@hitendrakumarshah3718]

You can download the training material from the link. The link is available in the description section of the same recorded webinar. The link will be valid for only April 16,2023.

[@anildesai334]

Does 483 observations convert into Warning letter?

[@hitendrakumarshah3718]

Yes.

[@Bharatpithiyalive]

Sir,
Please help to get training material.. Link was expired

[@hitendrakumarshah3718]

Link was given during my first day of training. Now, I need to check for content to share separate link.

[@Bharatpithiyalive]

@@hitendrakumarshah3718
Ok...

[@venkatalaxmi6778]

Sir can u pls share the PPT to me

[@hitendrakumarshah3718]

The PPT is shared during the LIVE Training only.

[@kevinch7954]

Hi sir

[@hitendrakumarshah3718]

Hello

[@hitendrakumarshah3718]

Hi

[@kevinch7954]

@@hitendrakumarshah3718 I am working in api production 8 y exp. I want to learn a compliance related audit course. can you please suggest to me which course is suitable for me