• Governance, Risk, & Compliance

Pacira Sr. Director, Quality Assurance

 

We have an annual requirement of eight hours of cGMP training during the year for direct employees in manufacturing and four hours for indirect. The topic that I had requested was any type of PAI training.  Bob put together an excellent Statement of Work (SOW) training entitled “Are you Ready for a PAI?” which Pacira was in the process of PAI preparations for a new drug approval.  The training included individuals from the operators, analysts and included Executive Vice Presidents.  The session lasted for four hours and there was not a single individual in the audience that did not participate by asking questions, commenting on Bob’s expertise of the subject and overall gained in their cGMP awareness from the experience.  

In addition to cGMP training Bob and Ward Johnson, also from USDM, conducted a mock PAI audit.  Both Bob and Ward had a full knowledge of all the regulations and made several observations and comments to the CMC sections of our NDA which were corrected and resulted in a successful PAI outcome.  

I personally plan to use USDM for the cGMP program in 2012. The true professionalism and knowledge has been an asset to our cGMP program and I’d recommend USDM to anyone that is planning to upgrade or maintain their company cGMP programs.  It was a pleasure to work with individuals that know the subject and are able to communicate to all levels of employees where the message is understood and there’s no second guessing as to the meaning of the guidance’s.  If there is additional information that you might need concerning USDM please feel free to contact me at my contact information below. 

Sincerely, 
Russell Owen
Sr. Director, Quality Assurance
Pacira Pharmaceuticals, Inc. 

 

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