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A pharmaceutical consultant for more than 35 U.S. and foreign generic and PhRMA pharmaceutical firms since 1998, including consent decree remediation programs

A record of accomplishment in QA and QC; laboratory operations; regulatory compliance; R & D, and mfg management in the chemical and pharmaceutical industries

I get no greater satisfaction than guiding a client to resolving a problem, preventing others, while building an operating quality system to meet product and process needs, and regulatory guidance and requirements. Long-term, mutually satisfactory relationships ensue. My experience as a successful QC director during a consent decree informs my understanding of FDA expectatio...

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