Personal Information
Organization / Workplace
San Francisco Bay Area United States
Occupation
President, CAL'S Management Inc; Pharma Consulting
Industry
Medical / Health Care / Pharmaceuticals
About
Innovative, creative and effective Pharmaceutical Scientist/Executive having diversified experience/skills in Products R&D, Clinical Studies/Monitoring, Quality Assurance, Quality Systems/Compliance, Supplier Quality Management, cGxP Audits, Project Management for Consent Decree Remediation and Technology Transfer. Engaged in Clinical Supply/Distribution, weekly project meetings with remote Clinical Monitor/Clinical Project Leader. Participated Pre-Approval Inspection (PAI), Change Control, CAPA (using Trackwise), Analytical Method Validation/Transfer, CMO/CRO Due Diligence Auditing and Evaluation/Selection/Management (Sterile and non-sterile), Regulatory Affairs, CMC (eCTD), Clinical...
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