I would say this is the same but maybe that process validation can be for a succession of equipment. Like validation of 3 successive equipment. And equipment validation is for 1 equipment.
Excellent summary in a nutshell...this summary looks a lot like we do in our company...this podcast serves as a validation of our thinking on this topic
Excellent topic thank you for this comprehensive overview of an iceberg topic. Are you planning a separate DQ discussion? Including a legal challenge for marketing surveillance before and after the going to market or phased human trials?
Excellent information, but I thought that the rule of 3 has been removed and is no longer recommended since companies were defaulting to it instead of providing statistical significance, what do you think? Is that accurate? Please correct me if I am wrong.
Hi, not at all. There is no specific methods that are described to execute this. But this rule of 3 is providing some statistical measures to confirm the validation is correct. This was also recommended on the GHTF guidance. So this proves it is really considered by all companies.
Great session and very useful
Thanks for your support
What’s the difference between Process Validation and Equipment Validation?? How do you define that ??
I would say this is the same but maybe that process validation can be for a succession of equipment. Like validation of 3 successive equipment. And equipment validation is for 1 equipment.
Excellent summary in a nutshell...this summary looks a lot like we do in our company...this podcast serves as a validation of our thinking on this topic
Excellent topic thank you for this comprehensive overview of an iceberg topic. Are you planning a separate DQ discussion? Including a legal challenge for marketing surveillance before and after the going to market or phased human trials?
Hi Theresa, Nothing planned for now but I can look at it for another episode
I feel the organiser is interrupting too frequently with his questions and that distracted me a lot.
Urs-FAT-SAT-DQ-IQ-OQ ,Sop and finally PQ..
The person taking interviwe is unnecessarily talking and making interview bad
Monir let your guest speak more then you or else we lose the consistency or what topic is about
Thanks for your feedback. Sometime I get also too excited about the topics I am talking about so sorry for that.
@@EasyMedicalDevice no need to be sorry I learns a lot from you 😁 you are a GURU
Very good information sir...
Thank you so much dear sir❤️
Nice 🙂
Is the link for downloading the templates still working? I tried to download them with no success
Thank you for the detailed information. but I have one question.
How to perform validation of process for customized medical device?
Thanks for detailed information and explanation.
You’re welcome
Superb discussion. Thank you!
Thanks for info and the validation toolkit is so useful
🙏
Can you kindly provide the steps of IQ,OQ PQ for steam sterilizer?
Normally you are following the protocol… or if there none then you might have to create… and in that case FAT/SAT would be very helpful.
Excellent information, but I thought that the rule of 3 has been removed and is no longer recommended since companies were defaulting to it instead of providing statistical significance, what do you think? Is that accurate? Please correct me if I am wrong.
Hi, not at all. There is no specific methods that are described to execute this. But this rule of 3 is providing some statistical measures to confirm the validation is correct. This was also recommended on the GHTF guidance. So this proves it is really considered by all companies.
Very knowledgeable.
Thanks ruba, really appreciated
What is the difference between process validation and machine qualifications?
Machine qualification is going under process validation which is covered much wider range of different tasks
Great useful sharing!
Do we need PQ on post sterile products or only pre sterilized? Please someone answer this. Thanks
Both.
You are PQ every single individual equipment
GOOG CONTENT , MERCI