Phil is an experienced quality/compliance professional with 16 years experience in the pharmaceutical, medical device and biologics industry. He has a record of success developing and managing quality systems to support these businesses.
He has a breadth of experience performing/coordinating compliance audits involving CFR210/211, CFR820, ISO13485, QSR/PAL and CMDCAS regulations.
Phil has provided expert counsel in quality systems for early development projects; pioneering drug/medical device/drug combo quality systems and compliance initiatives; designing statistical and attribute analysis programs for manufacturing processes; continuous improvement, auditing, supplier quality management, technology transfer and validation support; statistical process controls; QA expertise for development activities, design controls and GCP for both medical device and drug products.
Phil is the owner and principal consultant of Innovative Consultants GXP. Innovative Consultants offers a range of regulatory compliance and quality assurance services. Inspection readiness is an expertise that Phil and his team of associates provide clients to benefit their compliance profile and foster success in the market place.
Online Resume