With over 30 years experience in the regulatory/quality arena in contract facilities, I've developed expertise in Good Laboratory (GLP) and Good Manufacturing Practices (GMP). I've held roles in Quality Assurance management since 1982 with responsibilities in EPA/FDA GLP and FDA GMP compliance, and most recently was VP of Quality and Regulatory Affairs at Ricerca Biosciences, LLC.I have special expertise in Compliance/Training with a solid foundation in GLP preclinical programs. I led the development of a GMP program for Active Pharmaceutical Ingredients (APIs) manufacturing which resulted in successful Pre-Aproval Inspections (PAIs) from FDA for both manufacturing and Analytical processes. In the Regulatory area, I have written, coordinated and submitted the Chemistry, Manufacturing and Controls (CMC) Drug Substance section for Common Technical Document (CTD) Quality Modules of INDs and NDAs for multiple clients.Throughout my career, I've gained the reputation for creating science-based quality programs through collaboration with all technical contributors. This was accomplished through careful examination of any current processes with a conscious effort to consolidate accountabilities, provide defensible documentation and lower expenses, but not at the risk of reducing quality, reliability or customer service.My work experience is complemented with a BA degree in Chemistry, an MBA in General Management and the RQAP-GLP and RAC certifications. I am a 28 year member of SQA, and have served as President, with 7 years as a Board of Directors member.My goal is to create solutions to compliance issues that provide measurable and sustainable results through increased effectiveness, while lowering operational expenses.Specialties: GLP; API GMP; Regulatory Affairs - CMC; GLP/GMP Training; GLP/GMP Gap Assessments; Vendor/subcontractor Audits.