FDA Smart News & Events
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Modern Pharmaceuticals Interview with FDASmart.
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FDA Smart
Express Pharma Official Interview with FDASmart Inc.
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FDA Smart
Attended at Pharmaceutical Ingredients Japan 2009.on 1st to 3rd July, Tokyo Big Sight, Tokyo.
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FDA Smart
Exhibitor at Bangalore Bio 2009 held on 18th to 20th June. Bangalore, India.
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FDA Smart
We are partnering with India's leading clinical research training institute-ICRI
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SmartInspect :


Pfizer Inc. in the US is a customer, Sanofi Aventis   is CURRENTLY evaluating  the technology and  after one meeting/demo, Glaxo Smith Kline and Bristol Meyers Squibb in the US have expressed interest as well, i.e. includes TOP three (3) of the TOP 10 global big pharma companies in the industry.

Daiichi Sankyo in Japan has requested pricing. Discussions with senior management at Astellas HQ  are underway with Tokyo.

There’s a pattern here.  There must be something to this ?

The Director of  DMPQ at the US FDA (Division of Manufacturing & Product Quality) had this to say about Smartinspect:
This technology does sound like it has some promise to help a firm's external auditors with additional expertise in some cases, without being at the audited site

The Editor in Chief of Pharmaceutical Technology, Iselin, New Jersey in the US  made the comments below:
It’s very exciting to hear about all of your success with SmartInspect, and with increased concern about supply-chain security, I’m sure you’ll only increase your demand”


SmartInspect is  a state of the art mobile, wearable, wireless conferencing tool to help you manage your pharma/biotech supply chain.

◙  SmartInspect…. is a new, wearable , wireless, mobile video-audio technology (VoIP)  that works with standard wireless technology (Wifi 802.11b/g) using Internet broadband or 3G cellular phone connection.
In a nutshell, it’s  a wearable “seeing”, “talking”  VoiP conferencing system with “feet”, YOURS !

◙   Using SmartInspect, one can REMOTELY Monitor, Guide or “Police” GMP quality audits for APIs  specially those  sourced from emerging ASIAN regions – Internet is (almost) FREE ! 

◙  Transmit headset camera, real time video via the Internet  while you communicate by audio using a Skype like service

◙  Record real-time, live video and audio  for archiving
or 
Keep  video/audio  recording as part of your  Quality Systems validation process
or
Re-purpose for training others in real-time or on demand


Here’s how Pfizer intends to use it:

  Smartinspect, fda inspection, quality audit, pfizer

 

 

 

 

 

 

 

 




We invite you to email us at
 rbalani@fdasmart.com  to SCHEDULE a FREE fifteen (15) minute, REAL-TIME DEMO  over the WEB.

  We will be using the  actual SmartInspect gear itself  ……while YOU view on your desktop  What Our  Handheld, VGA  quality
  video camera  SEES  as We Move About  While Talking with us LIVE Remotely!

While doing the DEMO :

 -   We can SEND you a SmartInspect video  recording instantly  of what you Saw or Heard during the DEMO or vice-versa!
-   To add to the fun….. you  could TAKE a SNAPSHOT (photo)  of what our Wearable, REMOTE CAMERA SEES  from your Desktop and SEND it  to   us on one button click!
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We guarantee innovative ideas for SmartInspect use will occur to YOU  to deliver more efficiency, minimize costs or both with your Quality Audit process  & beyond!

◙  HELP YOU MANAGE THE NEW PHARMACEUTICAL GLOBAL SUPPLY CHAIN
◙ Remotely  ASSIST with  3rd party supplier/vendor  GMP quality audits
◙  Do BioPharma remote DISTANCE TRAINING away from the CLASSROOM and out WHERE it belongs, i.e. the Actual Production Facility site or in front of bioreactors or PLCs !
◙ Monitor Clinical Trial Studies outsourced to CROs  in emerging countries without the COST or Jet Lag !
◙ Remotely “Police” API sourcing from overseas (China/India, etc.),  i.e. THERE IS NO NEED TO REMAIN SLEEPLESS with ASIA  !

 

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