Hi,

Can anyone send me a template for Validation Master Plan ?

Thanks,
AB :yes:

Hi,

Can anyone send me a template for Validation Master Plan ?

Thanks,
AB :yes:There's one on the clinivation site (http://www.clinivation.com/pages/resources/downloads.php).

I am attaching a file concening the validation master plan and its design. If you let me know what is the process you are validating, I may find in my library something useful.5365

Hi Gaman, thanks for the attachment. I am looking VMP for the molding equipments.

Regards,
AB :)

Hi Gentleman,

Thank you for your attachment.

Can you share any example of validation master plan of a medical device production plant?

Thanks a lot!

:thanx:

Hi there I am validating a full sustem inc of meter and medical device, can you help. It will include the overall functionality of the device and the workings of the meter.

Regards

Hi there I am validating a full sustem inc of meter and medical device, can you help. It will include the overall functionality of the device and the workings of the meter.

Regards

Welcome to the Cove. Can you be more specific in your requirements - ie. if you are molding individual parts and then assembling the device in your facility ?

Also you can use the SEARCH function to get your desired information.

Hi Guys,
Thanks for the VMP pdf. I ahve to validate drug safety system.. can one of you share the VMP if you have one?

Regards, Suresh.

Hi Guys,
Thanks for the VMP pdf. I ahve to validate drug safety system.. can one of you share the VMP if you have one?

Regards, Suresh.

There is good information for preparing the VMP on page 4 and 5 of the attachment and you could customize as per your requirements.

Hello, I'd like to download the validation master plan in one of the previous messages, but I can't. It sends me to the login page. Anybody knows why?

Hello, I'd like to download the validation master plan in one of the previous messages, but I can't. It sends me to the login page. Anybody knows why?You need to register on clinivation.com to gain access to the downloads. The registration is free.

Hallo,
I am urgently also need a template for the qualification of a pharmaceutical facility. Could someone help me please?

Thank you,
Kind regards

Hallo,
I am urgently also need a template for the qualification of a pharmaceutical facility. Could someone help me please?

Thank you,
Kind regardsSee if this is helpful
PHARMACEUTICAL MASTER VALIDATION PLAN: FREE DOWNLOAD MEDICAL EBOOKS (http://www.freemedicalebooks.net/?p=13166)

You will need to wait about 2 minutes for the free download.

Hi Al,
Thank you for the link. :thanx:
But the "Free download link" is not activated although I waited up to 5 min. Which button do I have to use "Free download link", "download" or "mirror"?
Kind regards,:)
Blume

Hi Al,
Thank you for the link. :thanx:
But the "Free download link" is not activated although I waited up to 5 min. Which button do I have to use "Free download link", "download" or "mirror"?
Kind regards,:)
Blume

The 'Free download link' is not a link - it tells you that 2 links are provided:
Download or
mirror.

Choose one that works - for my area, the mirror (megaupload) works but not the other.

Hi Al,
Thanks for your help.:thanks:
The download worked now. So I can study the content now.
Kind regards,
Blume

It's interesting how everyone jumped in on the assumption that the topic being referenced was a PROCESS validation master plan. We, on the other hand are wrestling with a format for a DESIGN validation plan, an effort which we find equally challenging.

I've thrown together a template in this regard if anyone is interested as I'd need to "genericize" it before posting....

Does actually one must have a Validation Master Plan? We never had one, and as I know, it is not required by the standard.

Hi all-

Check out a company called Kymanox. They provide technical project management and engineering services, including validation work, for the biotech, pharmaceutical, and medical device industries.

They have an online store called KymaSTORE which has a wide variety of templates and training packages that may be of use to you.

Hope this helps.

-Alyson

Hi all-

Check out a company called Kymanox. They provide technical project management and engineering services, including validation work, for the biotech, pharmaceutical, and medical device industries.

They have an online store called KymaSTORE which has a wide variety of templates and training packages that may be of use to you.

Hope this helps.

-Alyson

Alyson, are you by any chance associated with this organization?

Stijloor, Moderator.

Stijloor-

Yes, I do work for Kymanox part-time. I've seen the templates that they have available for purchase and thought they might be helpful. If it was an illegal post I could delete it, and I apologize if I broke any rules of the forum. I was just trying to provide a valuable service to those who needed resources.

Best regards,
Alyson

Yes, I do work for Kymanox part-time.

That's what I thought when I read your post.

The fact that you work for a company should be mentioned whenever recommending them.

Stijloor-

Yes, I do work for Kymanox part-time. I've seen the templates that they have available for purchase and thought they might be helpful. If it was an illegal post I could delete it, and I apologize if I broke any rules of the forum. I was just trying to provide a valuable service to those who needed resources.

Best regards,
Alyson

Alyson,

A simple line in your post stating your association with this company will suffice. You can also include a simple reference in your post such as: "See my personal profile for additional information." We are very sensitive to people promoting their wares... But you're OK.

Stijloor, Moderator.

Sorry for jumping into your thread. :o It was the only way to get in from my location. :frust:
I just started a new job and I am searching for process validation training courses. Can someone help me?
:thanks:

It is interesting that so many people take "Master Plan" to be the instructions for completing specific validations. We have a simple "Validation Master Plan" which lists all elements in the company (Equipment, Processes, etc) which require some type of qualification and then list which qualifications those require. Once we have our "master" plan established, then we create specific instructions for each element.