Outsourced processes and ISO 9001:2008
1:17:22
Medical Device Design Control
59:53
8 жыл бұрын
Managing the Medical Device Supply Chain
1:05:37
FDA Requirements for Device Labeling
1:10:24
How to prepare for an FDA inspection
58:29
FDA QSR Requirements for DMR & DHR
59:20
cGMP for Medical Devices Including IVDs
1:16:37
Пікірлер
@zul.cenaheyn
@zul.cenaheyn 6 күн бұрын
Is 510k documents needed for ultrasonic dental tartar removal machine?
@carol_hyejinkim
@carol_hyejinkim 5 ай бұрын
Great webinar. Thank you😊
@yumingzhao5577
@yumingzhao5577 5 ай бұрын
True expert
@user-gl2ux3dr1j
@user-gl2ux3dr1j 7 ай бұрын
Thanks for the information
@Anon-up3be
@Anon-up3be 7 ай бұрын
This place is an email spam factory.
@timglover4180
@timglover4180 8 ай бұрын
Really good video content and really helpful! Unfortunately I had to listen to it multiple times and keep rewinding as the sound was quite muffled, I tried it on multiple devices.
@benlee3545
@benlee3545 11 ай бұрын
hi, your video is good. you also share some of the experience you have in software but it will be better if you can include examples of the device master record for clearer illustrations and templates etc.
@ysshaikali1643
@ysshaikali1643 Жыл бұрын
Thank you for your information. I learned, understand well
@jerrylee2698
@jerrylee2698 Жыл бұрын
arrest the medical mafia
@lissaoneill8008
@lissaoneill8008 Жыл бұрын
44:50 Stock Recovery. Interested to know would this be considered stock recovery?: manufactured lot has known defect. Some part of lot was distributed but it is known that all distributed devices were used up with no harm. The firm still decides to destroy what's left in stock - would this be a stock recovery since it is known nothing is currently in distribution or it is no longer stock recovery since part of lot had been distributed and it doesn't matter whether there is nothing in distribution anymore?
@SamHarmony2
@SamHarmony2 Жыл бұрын
Thank you for the content. Very helpful! Is it possible to receive a copy of this powerpoint presentation?
@AbbyGhignone-yy7yt
@AbbyGhignone-yy7yt Жыл бұрын
I miss you papa. I love you. You’re amazing.
@beaudyorcel4987
@beaudyorcel4987 Жыл бұрын
This is a great presentation
@sonandpets1215
@sonandpets1215 Жыл бұрын
What an incredibly, clear, and to the point presentation
@NazrulIslam-kb2tt
@NazrulIslam-kb2tt Жыл бұрын
How can i get pdf of this presentation?
@liorx10
@liorx10 Жыл бұрын
Thanks I really appreciate your explanation, it was definitely very clear and educated.
@CityWalkSHA
@CityWalkSHA Жыл бұрын
Still a very good training material today! Thank you!
@davidmuseau1406
@davidmuseau1406 Жыл бұрын
Seriously get rid of that straw Dan
@tinthings314
@tinthings314 Жыл бұрын
Very good overview of validation principles, thank you very much
@dorrinasefi9400
@dorrinasefi9400 Жыл бұрын
I wish i read the comment. No content here!
@SanthoshKumar-np8pr
@SanthoshKumar-np8pr Жыл бұрын
Great session
@fadumaali5738
@fadumaali5738 Жыл бұрын
Thank you, I learned a lot from this webinar
@davidfrancis1299
@davidfrancis1299 Жыл бұрын
Fantastic overview! I am saving for reference. Please let me know if there is an updated version. Great job!
@caseykrauter3422
@caseykrauter3422 Жыл бұрын
The sound in the video cuts off at minute 45. Can you reupload the video and verify that the sound works after minute 45?
@kkwok9
@kkwok9 Жыл бұрын
Nice job Thorough, formal, technical and to the point. Thank you Sir
@gxpmatters5705
@gxpmatters5705 2 жыл бұрын
kzfaq.info/love/yB3GFq6cWuAZzGWpnTX70A
@daltonymd8391
@daltonymd8391 2 жыл бұрын
sterilization is definitely design output, biocompatibility aswell
@sanketmane7109
@sanketmane7109 2 жыл бұрын
Thank you🙂
@kkwok9
@kkwok9 2 жыл бұрын
A nice presentation. This gal knows her stuff. Thank you
@abhilovemarvel1810
@abhilovemarvel1810 2 жыл бұрын
sir i want some book suggestion where i get knoledge abou this think
@kkwok9
@kkwok9 2 жыл бұрын
This gal knows her stuff. I have heard her other presentations on your channel. Melinda is an amazing speaker
@bobtan9321
@bobtan9321 2 жыл бұрын
Sounds impressive but don't be taken in. NOt listed is Preventing doctors from seeing Clinical Trial Data. As it is clear, many of you are not aware of Pfizer's clinical trial data being locked up for 75 years by our boys at the FDA. Also not listed is the dictatorial ruling by the FDA to ignore the warning of the Advisory Committee on Vaccines, "Members of the FDA advisory committee struck a skeptical tone during the meeting Friday, questioning Pfizer's conclusions that immunity is waning to the point that vaccinated people of all ages" It is sad that so many people that should know better are duped by an FDA that's been running amuck. Houston, we've got a problem, a huge problem of integrity. And we are all being played.
@shivakumar-ll6ro
@shivakumar-ll6ro 2 жыл бұрын
Sir can you please explain me in standard iso 2859 or is 2500 Based on lot size and sample size we have accept and reject numbers I want to know how those accept and reject numbers are calculated and created .... please do needful 🙏🙏🙏
@TeW33zy
@TeW33zy 2 жыл бұрын
Didn't even understand half the words? What is the document he said download. I couldn't make out the word cusid?
@TeW33zy
@TeW33zy 2 жыл бұрын
What is cusid?
@paragkale5459
@paragkale5459 2 жыл бұрын
nice
@kkwok9
@kkwok9 2 жыл бұрын
Very nice. Information was much appreciated
@kkwok9
@kkwok9 2 жыл бұрын
Good information. Thank you
@jennifercamison3815
@jennifercamison3815 2 жыл бұрын
Very helpful video
@kkwok9
@kkwok9 2 жыл бұрын
Excellent presentation Thank you folks
@parveshthakur2979
@parveshthakur2979 3 жыл бұрын
Can i Get this course certification
@nguyentung5406
@nguyentung5406 3 жыл бұрын
can you upload slide show pdf, it'll be fantasic
@BharathKumar-gm5zz
@BharathKumar-gm5zz 3 жыл бұрын
Very good information sir, Is analytical development formulation department is come under A R&D in pharma industries.
@tlm7790
@tlm7790 3 жыл бұрын
Outstanding job Dan!
@kkwok9
@kkwok9 3 жыл бұрын
Good stuff Shes good at presenting
@orisolesolutions3867
@orisolesolutions3867 3 жыл бұрын
Introduction to regulatory affairs. Scope and Opportunities of Regulatory Affairs . kzfaq.info/get/bejne/fdmCgq6JprqdY4E.html
@kevinkane6418
@kevinkane6418 3 жыл бұрын
What a complex protol(s) to follow!!!!! excellent information and clinically sound, thank you!!!!!
@genekim1426
@genekim1426 3 жыл бұрын
Extremely clear, concise overview of the FDA drug approval process. Thank you!
@kkwok9
@kkwok9 3 жыл бұрын
Nice job Mr O'leary