Managing Director Life Sciences and Healthcare
Managing Director, Life Sciences and Healthcare focus on the Life Sciences Regulatory Consulting providing consulting to many Fortune 500 Pharmaceutical, Medical Device and Biotech companies. I fous on strategic guidance and management in areas of compliance and regulatory affairs. I work with clients in the areas of IT Validation, Compliance with 21 CFR Part 11, and Risk-Based Approach to Regulatory Compliance Management. He has over 16 years experience in regulatory compliance concerning the manufacturing and distribution of both pharmaceutical and medical device products. Pat has strong project management and technical experience regarding the implementation and validation of various applications and systems supporting manufacturing and distribution including ERP, EDMS, CAPA, WMS, and e-Pedigree. Pat holds a Master’s in Information Systems from Eastern Michigan University and MBA from SSIM.