Ana Paula Azevedo

Currently works with medical device registration in APAC countries, and also has experience with medical device registration in Brazil and Latin America. Responsible for legalization of the company and your brands in the Brazilian regulatory agencies Activities: Preparation of registration portfolio according to the market strategies and engineering project development plans; Registration schedule;Technical analysis of the documents; Regulatory strategies for new projects and changes; Review of materials.

Technical responsible of group companies, regulatory affairs (registration and post registration of health products), legalization of companies in the regulatory agencies, quality assurance based on RDC 16/2013, production and logistics of dental products.

Management of the Quality Assurance, Control System, Quality Projects; Customer Relationship and Regulatory Affairs. Strategic planning, training of employees, review and approval of documents, preparation of indicators, evaluation and qualification of suppliers, technovigilance, treatment and analysis of deviations within the QMS aiming .Application of Quality Tools, FMEA Risk Management, Change Control, Lead Auditor. GMP( Brazil); EN ISO 13.485 ;ANBT NBR ISO 14971: 2009.

Responsible for the sector, Pharmaceutical Logistics, Technical Assistant (regulatory affairs), Qualification of Cold Chain Equipment, Audit Plans, Qualification of suppliers, Qualification of carriers, Pharmacovigilance, Quality Deviations, Implementation of Cold Chain Project (qualifications, validations, control software), Training, Technical Visits, Member of the Internal Commission for Accident Prevention and Fire Brigade.

Technical Responsible; Medication Dispensation, Customer Service, Quality Assurance of products and services, Psychotropic Control, Injection Application, Regulatory Affairs, Career Plan Training.

MBA in Project Management.

Audit and Quality Management in Logistics Processes, Industrial Chain and Post-Use Surveillance