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?
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.
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.
@@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
Please share FDA SOP as discussed in this session
You can check the description section. The link is shared to download the FDA document.
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?
Thank you for your kind comment. Once the CAPA is accepted by the compliance team of FDA, EIR will be issued by FDA
Kindly make video HVAC system with important guidline reference.....
Sure. I will make training on it.
Please share FDA guidelines
You can get the link from the description of the recorded webinar. You can access from the same link.
When should FDA issue EIR? What will be time frame after inspection?
For EIR, there is no time frame for FDA
Sir nice session .Informative one.please provide guideline referance
You can get the guideline link from the description section of the same recorded webinar.
What is the role of USFDA regarding 483....they only issue 483 but not guiding regarding US federal standard.
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.
Sir will u share ur slides also so that it will be easy to recollect all
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.
After receipt of compliance report by FDA, how many days FDA will take for review and clearance? Any time limit is there?
Normally it takes about 15 business days to review CAPA by FDA.
Does 483 observations convert into Warning letter?
Yes.
Sir,
Please help to get training material.. Link was expired
Link was given during my first day of training. Now, I need to check for content to share separate link.
@@hitendrakumarshah3718
Ok...
Sir can u pls share the PPT to me
The PPT is shared during the LIVE Training only.
Hi sir
Hello
Hi
@@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