María A. Mangiapane Email and Phone Number

25 years Experience in the industry, Enthusiastic, and Very Self-Driven.Website:https://www.mangiapanequalityconsulting.com/Today’s working environment has evolved into innovative technologies that facilitate and provide for fast deliverables while reaching out multiples global teams under remote working models around the World. With that in mind, my goal is to provide flexible models of remote Quality Assurance and Compliance consulting services for the Pharmaceutical, Biopharmaceutical and Medical Device industries (API & Finished Product). Areas covered:* CMOs commercial and clinical * CAPA* Root Cause Analysis * QRM* Validation * Developing personnel * R&D* Technology Transfer * Complaints * Batch Record/Device History Record Review * Product Release * Training TTT* SOPs* MWIs* Guidance for regulations and standards: EU MDR, GMP, 21CFR 210, 211, 820, part 11, ISO 13485, European Certification (EC) and ICH Q7. * TrackWise Standard and Digital * KPIs* Remediation * Fluent in Spanish