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Thank you Mr. Golden, this is very helpful

👌👌

We appreciate your efforts from India

Excellent discussion. We love watching your quality discussion from India

Excellent discussion. Thanks very much

Thnx

How are combination products classified in Europe as in EU MDR ?

Single entity combo products must be chemically combined, like “silicone ring combined with progesterone”. Where the silicone ring is used as a delivery vehicle to deliver the drug product. Not sure if a pen injector is a single entity combination product?

A very interesting insight. It's fantastic to view the universal transition away from Computer System Validation toward Computer System Assurance. Also excellent to see how important it is to have a partner.

Thank you Stacy

Very nice presentation ... Speaker is very passionate to the topic Thnx "Voices in Validation"

Very nice thnx

How are you going to justify not validating "big data algorithms", regardless of what data (primary og supportive) they are analyzing, if the direct output of those algorithms are used for making decision affecting product quality or patient safety? The need for validation depends on intended use. Some kind of validation of those algorithms has to be done surely. "Self-validating" is not a concept in itself nor exact science, but relies on the person/system behind producing the algorithm. Arguing that Tesla is not performing process validation is not an valid argument.

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How should the storage conditions limits be established? For example temperature from 0 to 45°C.

Can the panelists comment on the following pl? 1. There are lots of tools that are coming in today for testing, devops etc., to what extent do we need to extend the Qualification to these tools? 2. Are there clear pointers coming as to where its reqd n where its not? Where do we stop?

Thank you so much ... one note please about the filter example: is it allowed to write on piece of paper outside the official record?

Loved this episode!!

Unfortunately the discussions were hardly on Test automation which the topic was supposed to be

Can u pl.send the cybersecurity SOp that you were talking about...to. gsvk68@gmail.com

Thanks a lot for the channel a d topics pl. Can you pl let know when are you planning to hold the webinar on the standards that were being spoken about. Is it possible to list them down in the description to start with or point us to any link that has it?

It's was very knowledgeable conversation. Thank you really got insight about CSA.

Excellent information

First time visit. THANK YOU SO MUCH for Drs. Bernard Hsu and Paul Pluta on YOUR show! Added your and their links to my SUBS! In a more humorous vein I was reminded about a "NEW" laxative in competition with ExLax is... "FeatherLax" ... which seems to "tickle-the sh*t" out of you! BUT, warning, if you overdose you may die laughing!

Sorry to say very less informative.

Thank you so much from India

Ajaz Hussain 👌

I am a CSV(quality analyst) professional. I should say that was an excellent discussion on CSA and it helped me a better idea on the topic. But I have few questions and it would really be helpful if some expertise could answer it. 1. If there will be less focus on documentation of test records, what exactly would a QA do? Will QA become a risk based "tester" ? Then how different will a tester be different from a Quality Analyst? How is the risk identified? 2. Will CSA require less quality analysts than CSV as there will be very less documentation? In other words how does CSA impact on jobs?

This is a wonderful session😃👍

Deep thinking and great sharing about CSV and CSA, Thank You

thanks for the important information . could you please do some more videos on CSV

Good Info

Thank you for this insightful forward-thinking approach to computer system validation that integrates both technology and methodology