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FDA GMP @FDAGMP

FDA expert in GMP regulations pharmout.net Asia Joined May 2009
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FDA GMP @FDAGMP

10 years ago

All in a twitter about the newest US FDA social media guide - PharmOut Blog pharmout.net/blog/all-in-a-…

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FDA GMP @FDAGMP

13 years ago

Check this video out -- Screencast by PharmOut from Screenr.com youtube.com/watch?v=xcmFGa… via @YouTube

FDAGMP Profile Picture

FDA GMP @FDAGMP

13 years ago

All the FDA, TGA, EU, WHO etc regs in one place. Free search - gmp.pharmout.net

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FDA GMP @FDAGMP

13 years ago

US/EU/Australia pharma inspection pilots "successful" pharmatimes.com/Article/11-08-…

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FDA GMP @FDAGMP

13 years ago

In 1971 the TGA GMPs mentioned risk 3 times, 20 times in 1990, 57 times in the 2002 and 390 times in the 2009 and in your next audit?

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FDA GMP @FDAGMP

13 years ago

Do you think that the regulators asking for a Risk Based Approach (RBA) is a cop out from writing decent codes of GMP in the first place?

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FDA GMP @FDAGMP

13 years ago

The Australian TGA are asking for CAT 5 computer cables to be "validated", i.e. Temp and RH?

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FDA GMP @FDAGMP

13 years ago

Australian TGA website down and returns 404 errors... ebs.tga.gov.au joins the South African website being down frequently....

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FDA GMP @FDAGMP

13 years ago

FDA publishes ICH Q11 for comment. The look awaited guidance has finally reached public domain. fda.gov/downloads/Drug…

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FDA GMP @FDAGMP

13 years ago

CSL Flu - FDA and TGA come to an agreement on GMP violations, read this off the TGA website. tga.gov.au/newsroom/btn-c…

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FDA GMP @FDAGMP

13 years ago

FDA approves this first iPhone app to help in with PET diagnoses, called "iDiagnose".

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FDA GMP @FDAGMP

13 years ago

Some should tell him if you outsource, you should have a reduction in costs!

FDAGMP Profile Picture

FDA GMP @FDAGMP

13 years ago

President Barack Obama is requesting a $4.4 billion budget for the FDA for fiscal 2012, a 33 percent increase over the agency’s 2010 budget.

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FDA GMP @FDAGMP

13 years ago

"We're looking at anything, anything and everything that will allow us to leverage our resources better."

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FDA GMP @FDAGMP

13 years ago

"We recognize that third-party inspection programs need to be a bigger part .... we can't do all the work ourselves," FDA's John Taylor

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FDA GMP @FDAGMP

13 years ago

FDA to contract out more foreign inspections? Unbelievable?

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FDA GMP @FDAGMP

13 years ago

FDA GMP for PET Guidance - http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078738.pdf

FDAGMP Profile Picture

FDA GMP @FDAGMP

13 years ago

New FDA guidance for Industry PET Drug Applications — Content and Format for NDAs and ANDAs - Link to follow

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FDA GMP @FDAGMP

13 years ago

FDA Link - Process Validation http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf

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FDA GMP @FDAGMP

13 years ago

Draft Process Validation Guidance adopted by the FDA and released on Jan 2011. Link to follow.

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