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 The staff of Whetstone Associates, Inc. has extensive experience with Positron Emission Tomography and with the production and testing of FDG.  One member of our group was directly involved in the development of the first PET cyclotron and in the establishment of the first commercial FDG production and distribution center in the United States in the early 1990s.
 
We have successfully submitted Radioactive Material License applications and cyclotron registrations in nine different States.

 

 We are experienced with the various requirements set forth by the Food and Drug Administration (FDA), the United States Pharmacopeia (USP) and the Code of Federal Regulations (CFR) as they apply to the manufacturing, testing and distribution of FDG.
 We have successfully brought seven different FDG production facilities into FDA compliance.  This was accomplished by developing documentation (Standard Operating Procedures, Raw Materials Specifications, Quality Manual, Radiation Safety Manual, etc.), implementing comprehensive training programs and conducting thorough compliance audits. 
 


John Haynes, President

 John has more than 25 years experience in the PET industry.  He was with EG&G ORTEC in Oak Ridge, Tennessee when they developed the first commercial PET scanner.  Later, he was with CTI in Knoxville, Tennessee and was a member of the team that developed the first self-shielded, negative-ion cyclotron for the production of PET radioisotopes.  John served as product manager for the cyclotron and Rb-82 infusion system product lines and was an active member of the team that developed the first commercial PET radiopharmaceutical production and distribution facility in the United States at St. Joseph’s Hospital in Tampa, Florida.

 

 

John was responsible for a network of seven PET radiopharmaceutical production and distribution facilities located across the United States.  He headed the compliance group that brought all seven facilities into compliance with the requirements of the USP and the FDA.
 John’s experience is supported by BS and MS degrees in Electrical Engineering from Auburn University in Alabama and an MBA in Marketing and Finance from Golden Gate University in San Francisco.  He has completed the course work for a Ph.D in Operations Management from the University of Tennessee in Knoxville.
 John is a member of Eta Kappa Nu, Tau Beta Pi and MENSA.


Experts in the field of USP and FDA compliance in the production and distribution of radiopharmaceuticals for PET imaging.

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